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Liu KC, Griffith KM, Richardson MK, Mayfield CK, Kistler NM, Lieberman JR, Heckmann ND. Safety and Efficacy of Aspirin Compared to Enoxaparin Following Total Hip and Total Knee Arthroplasty Among Patients Who Have a History of Venous Thromboembolic Disease. J Arthroplasty 2025; 40:1484-1491.e4. [PMID: 39561910 DOI: 10.1016/j.arth.2024.11.029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/29/2024] [Revised: 11/12/2024] [Accepted: 11/12/2024] [Indexed: 11/21/2024] Open
Abstract
BACKGROUND Despite the broad utilization of aspirin (ASA) as a venous thromboembolism (VTE) chemoprophylactic agent following total knee arthroplasty (TKA) and total hip arthroplasty (THA), few studies have evaluated its safety and efficacy in patients who had a history of VTE. This study sought to evaluate the safety and efficacy of ASA relative to enoxaparin in high-risk total joint arthroplasty patients. METHODS An all-payer claims database was queried for primary, elective THA, and TKA patients from January 2015 to December 2021. Patients who had a history of VTE were divided based on receipt of either ASA or enoxaparin as VTE prophylaxis. In a 1:1 ratio, 1,429 THA and 2,864 TKA high-risk ASA patients were matched to high-risk enoxaparin patients on age, sex, race, and presence of pertinent comorbidities. Multivariable regression analyses accounted for potential confounders. RESULTS After multivariable analyses, similar risk of pulmonary embolism (THA: adjusted odds ratio [aOR]: 0.85, 95% confidence interval [CI]: 0.26 to 2.76; TKA: aOR: 0.71, 95% CI: 0.38 to 1.32) and deep vein thrombosis (DVT) (THA: aOR: 1.12, 95% CI: 0.53 to 2.36) was observed in the ASA cohorts relative to the enoxaparin cohorts. TKA patients in the ASA cohort had a lower risk of DVT than those in the enoxaparin cohort (aOR: 0.57, 95% CI: 0.33 to 0.96). THA ASA patients demonstrated a reduced risk of stroke (aOR: 0.03, 95% CI: 0.00 to 0.73), while TKA ASA patients had a lower risk of acute blood loss anemia (aOR: 0.77, 95% CI: 0.66 to 0.88). CONCLUSIONS High-risk patients who received ASA demonstrated similar risk of pulmonary embolism and DVT, but decreased risk of bleeding-related and medical complications compared to patients who received enoxaparin. The utilization of ASA in high-risk patients was not associated with an increased risk of adverse outcomes.
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Affiliation(s)
- Kevin C Liu
- Department of Orthopaedic Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, California
| | - Kyle M Griffith
- Department of Orthopaedic Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, California
| | - Mary K Richardson
- Department of Orthopaedic Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, California
| | - Cory K Mayfield
- Department of Orthopaedic Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, California
| | - Natalie M Kistler
- Department of Orthopaedic Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, California
| | - Jay R Lieberman
- Department of Orthopaedic Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, California
| | - Nathanael D Heckmann
- Department of Orthopaedic Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, California
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2
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Salman LA, Altahtamouni SB, Khatkar H, Al‐Ani A, Hameed S, Alvand A. The efficacy of aspirin versus low-molecular-weight heparin for venous thromboembolism prophylaxis after knee and hip arthroplasty: A systematic review and meta-analysis of randomized controlled trials. Knee Surg Sports Traumatol Arthrosc 2025; 33:1605-1616. [PMID: 39228215 PMCID: PMC12022833 DOI: 10.1002/ksa.12456] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/28/2024] [Revised: 08/19/2024] [Accepted: 08/25/2024] [Indexed: 09/05/2024]
Abstract
PURPOSE The purpose of this study was to assess the efficacy of aspirin versus low-molecular-weight heparin (LMWH) in preventing venous thromboembolism (VTE) following hip and knee arthroplasty. METHODS PubMed/Medline, Embase, Cochrane Library and Google Scholar databases were searched from inception till June 2024 for original trials investigating the outcomes of aspirin versus LMWH in hip and knee arthroplasty. The primary outcome was VTE. Secondary outcomes included minor and major bleeding events, and postoperative mortality within 90 days. This review was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS A total of 7 randomized controlled trials with 12,134 participants were included. The mean ages for the aspirin and LMWH cohorts were 66.6 (57.6-69.0) years and 66.8 (57.9-68.9) years, respectively. There was no statistically significant difference in the overall risk of VTE between the aspirin and the LMWH cohorts (odds ratio [OR]: 0.95; 95% confidence interval [CI]: 0.48-1.89; p: 0.877). A subanalysis based on the specific VTE entity (pulmonary embolism [PE] or deep venous thrombosis) showed a significantly higher PE risk for patients receiving aspirin than the LMWH cohort (OR: 1.79; 95% CI: 1.11-2.89; p: 0.017). There was no difference in minor (OR: 0.64; 95% CI: 0.40-1.04; p: 0.072) and major bleeding (OR: 0.77; 95% CI: 0.40-1.47; p: 0.424) episodes across both groups. Furthermore, subanalysis among the total knee arthroplasty group showed that the aspirin cohort was significantly more likely to suffer VTEs than their LMWH counterparts (OR: 1.55; 95% CI: 1.21-1.98; p < 0.001). CONCLUSION This study demonstrated a significantly higher risk of PE among patients receiving aspirin compared to LMWH following hip or knee arthroplasty for osteoarthritis. Aspirin was associated with a significantly higher overall VTE risk among patients undergoing knee arthroplasty, in particular. This might suggest the inferiority of aspirin compared to LMWH in preventing VTE following such procedures. LEVEL OF EVIDENCE Level I.
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Affiliation(s)
- Loay A. Salman
- Department of Orthopaedic SurgerySurgical Specialty Center, Hamad General Hospital, Hamad Medical CorporationDohaQatar
| | - Seif B. Altahtamouni
- Department of Orthopaedic SurgerySurgical Specialty Center, Hamad General Hospital, Hamad Medical CorporationDohaQatar
| | | | - Abdallah Al‐Ani
- Office of Scientific Affairs and ResearchKing Hussein Cancer CenterAmmanJordan
| | - Shamsi Hameed
- Department of Orthopaedic SurgerySurgical Specialty Center, Hamad General Hospital, Hamad Medical CorporationDohaQatar
| | - Abtin Alvand
- Nuffield Orthopaedic CentreUniversity of OxfordOxfordUK
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Chen F, Guo J. The efficacy of aspirin compared to low molecular weight heparin as thromboprophylaxis after orthopedic surgery: A systematic review and meta-analysis. Phlebology 2025:2683555251325415. [PMID: 40080857 DOI: 10.1177/02683555251325415] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/15/2025]
Abstract
Background: Aspirin has increasingly gained attention as a thromboprophylaxis agent for patients undergoing orthopedic surgery; however, the results of recent clinical trials remain controversial. Therefore, in this meta-analysis, we compared the safety and efficacy of aspirin with those of low molecular weight heparin (LMWH) for patients undergoing major orthopedic surgeries leading to significant immobility and necessitating anticoagulants to prevent thromboembolic events. Methods: PubMed, Web of Science, Scopus, and the Cochrane Library were systematically searched from the inception to April 20, 2024, to identify clinical trials and randomized controlled trials comparing the effect of aspirin and LMWH on deep vein thrombosis (DVT), pulmonary thromboembolism (PTE), venous thromboembolism (VTE), major bleeding, short-term postoperative mortality, and adherence to treatment. VTE included DVT and PE in this study. A random-effects model (DerSimonian-Laird) was employed to pool data. Results: In total, 8 randomized controlled trials with 23,540 participants were included in this study. Compared to LMWH, the use of aspirin was associated with a significantly increased risk of DVT (RR 1.56, 95% CI (1.30-1.86), I2 = 0.00%), whereas no significant changes were observed in drug adherence (RR 1.04, 95% CI (0.94-1.14), I2 = 94.02%) and risk of PTE (RR 1.18, 95% CI (0.64-2.15), I2 = 58.64%), VTE (RR 1.51, 95% CI (0.89-2.57), I2 = 24.69%), major bleeding (RR 0.96, 95% CI (0.88-1.04), I2 = 0.00%), and mortality (RR 1.07, 95% CI (0.89-1.29), I2 = 0.00%) after orthopedic surgery. Conclusion: Aspirin is generally as safe as LMWH for preventing thromboembolic events among patients undergoing orthopedic surgery; however, aspirin can increase the risk of DVT.
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Affiliation(s)
- Feng Chen
- Emergency Department, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China
| | - Jing Guo
- Emergency Department, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China
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Liang F, Ren W, Chao M, Cheng RD, Ren JJ. Multimorbidity and Venous Thromboembolism: Epidemiological Evidence, Pathophysiology, Prophylactic and Therapeutic Anticoagulation Efficacy, Safety, and Difficulties. A Review. Clin Appl Thromb Hemost 2025; 31:10760296251333786. [PMID: 40232191 PMCID: PMC12035268 DOI: 10.1177/10760296251333786] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/10/2025] [Revised: 03/24/2025] [Accepted: 03/24/2025] [Indexed: 04/16/2025] Open
Abstract
Multimorbidity defined as the co-occurrence of two or more chronic comorbidities, is becoming increasingly burdensome and is a big challenge for healthcare systems all over the world. Venous thromboembolism (VTE) is a potentially lethal disease and is the third most common cardiovascular disease. Multimorbidity is closely associated with VTE, and the VTE risk is approximately fourfold higher in individuals with multimorbidity compared to those without. Notable and consistent evidences show a significant association between multimorbidity and VTE. Plausible mechanisms for the observed associations between multimorbidity and VTE have been outlined, including higher prevalence of identified VTE risk factors, organ function and coagulation function disorders, reduced physical activity, older age, low cognitive level of VTE, and complications following the multimorbidity. Worse therapeutic and prophylactic anticoagulation efficacy, and safety are suggested by the studies, and the VTE recurrence and bleeding risk are higher in patients with multimorbidity compared to those without. Management of the therapeutic and prophylactic anticoagulation for VTE in patients with multimorbidity is difficult, and a balanced and detailed evaluation of the risks of VTE and bleeding is needed, and antiplatelet medications, increased doses or alternative direct oral anticoagulants (DOACs), thromboelastography (TEG), and physical activity may be helpful.
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Affiliation(s)
- Feng Liang
- The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
- Center for Rehabilitation Medicine, Rehabilitation & Sports Medicine Research Institute of Zhejiang Province, Department of Rehabilitation Medicine, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou
| | - Wen Ren
- The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
| | - Min Chao
- The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
| | - Rui-Dong Cheng
- Center for Rehabilitation Medicine, Rehabilitation & Sports Medicine Research Institute of Zhejiang Province, Department of Rehabilitation Medicine, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou
| | - Jing-Jing Ren
- The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
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Williamson TK, Martinez VH, Verlinsky L, Brennan JL, Buttacavoli FA. The Fragility of Statistical Significance in the Use of Aspirin in Prevention of Venous Thromboembolism Events Following Total Joint Arthroplasty: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med 2024; 13:6369. [PMID: 39518508 PMCID: PMC11546331 DOI: 10.3390/jcm13216369] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/02/2024] [Revised: 10/17/2024] [Accepted: 10/19/2024] [Indexed: 11/16/2024] Open
Abstract
Background/Objectives: Comparative studies often use the p value to convey statistical significance, but fragility indices (FI) and fragility quotients (FQ) may better signify statistical strength. The use of aspirin as venous thromboembolism (VTE) chemoprophylaxis following elective arthroplasty has been debated between the orthopedic and cardiac fields. The purpose of this study was to apply both the FI and FQ to evaluate the degree of statistical fragility in the total joint arthroplasty (TJA) literature regarding aspirin (ASA) use for VTE prevention. Methods: We performed a systematic search for TJA clinical trials from 2004 to 2023 reporting comparisons between ASA and other chemoprophylaxis methods for VTE. The FI of each outcome was calculated through reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by study sample size and interquartile range (IQR) was calculated. SPSS Meta-analysis function was used to calculate the Mean Effect Size Estimate and 95% Confidence Intervals for each outcome. Results: Of 245 articles screened, 39 met search criteria, with 10 RCTs included for analysis (n = 11,481 patients). There were 38 outcome events reported, with three significant (p < 0.05) outcomes and 35 non-significant (p > 0.05) outcomes identified. The overall FI and FQ for all 38 outcomes were 6 (IQR: 5-7) and 0.059 (IQR: 0.044-0.064), respectively. Seven studies (70%) reported a loss-to-follow-up (LTF) greater than the overall FI. There was no increased risk of DVT, PE, or mortality with use of ASA (all p > 0.2). Conclusions: Despite showing non-inferiority in preventing venous thromboembolic events in TJA overall, the highest-level peer-reviewed literature concerning aspirin use following total joint arthroplasty is considered statistically fragile due to high loss-to-follow-up. In addition to the reporting of the p value, the fragility index and quotient can further provide insight into the strength and trustworthiness of outcome measures.
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Affiliation(s)
- Tyler K. Williamson
- Department of Orthopaedic Surgery, University of Texas Health San Antonio, San Antonio, TX 78229, USA; (V.H.M.); (L.V.)
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6
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Lun KK, Tang M, Lewin A, Harris IA. Aspirin as Venous Thromboembolism Prophylaxis in Arthroplasty Patients: An Analysis of Clinical Practice Guidelines Recommendations. J Arthroplasty 2024; 39:2405-2412.e1. [PMID: 38797455 DOI: 10.1016/j.arth.2024.05.050] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/24/2024] [Revised: 05/19/2024] [Accepted: 05/20/2024] [Indexed: 05/29/2024] Open
Abstract
BACKGROUND Venous thromboembolism (VTE) is a recognized postoperative complication of hip or knee arthroplasty and incurs major morbidity and mortality. While anticoagulants are the mainstay of chemoprophylaxis, aspirin has recently emerged as a popular prophylactic agent. However, there is a lack of high-quality evidence comparing aspirin to anticoagulants as a method of VTE prophylaxis, and current guidelines are conflicting regarding using aspirin as first-line chemoprophylaxis. We aimed to investigate guideline characteristics that are associated with the recommendation for or against aspirin as a first-line agent. METHODS MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and PubMed databases were searched from 1966 to January 2024 to identify clinical practice guidelines for VTE prophylaxis in adult hip or knee arthroplasty inpatients of average risk. The characteristics of the guideline were collected by 2 independent reviewers. Logistic regression was used to test the association between the recommendation for or against aspirin and guideline characteristics. RESULTS There were 26 guidelines published from February 2003 to September 2023 and included in this study. There were 5 guidelines that recommended aspirin and 11 guidelines that recommended against aspirin as first-line therapy. With a more recent year of publication, aspirin was more likely to be recommended (odds ratio 1.72, 95% confidence interval: 1.05 to 2.84) and less likely to be recommended against (odds ratio 0.61, 95% confidence interval: 0.41 to 0.90). No other variables, including the level of evidence used, the composition of the guideline working group, or the objective of the guideline, were associated with the recommendation for or against aspirin. CONCLUSIONS Guidelines were inconsistent in their recommendations regarding aspirin as first-line therapy as VTE prophylaxis in arthroplasty patients. Adequately powered randomized controlled trials using modern practices, such as early postoperative mobilization, are needed to better inform clinical practice guidelines.
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Affiliation(s)
- Kimberley K Lun
- The Faculty of Medicine and Health, The University of Sydney, Camperdown, NSW, Australia
| | - Matthew Tang
- School of Clinical Medicine, UNSW Medicine & Health, UNSW Sydney, Sydney, NSW, Australia
| | - Adriane Lewin
- School of Clinical Medicine, UNSW Medicine & Health, UNSW Sydney, Sydney, NSW, Australia
| | - Ian A Harris
- School of Clinical Medicine, UNSW Medicine & Health, UNSW Sydney, Sydney, NSW, Australia
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7
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Zhang X, Ren Y, Luo H. Comment on 'The role of aspirin versus low-molecular-weight heparin for venous thromboembolism prophylaxis after total knee arthroplasty: a meta-analysis of randomized controlled trials'. Int J Surg 2024; 110:5907-5909. [PMID: 38775539 PMCID: PMC11392074 DOI: 10.1097/js9.0000000000001672] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/07/2024] [Accepted: 05/09/2024] [Indexed: 09/15/2024]
Affiliation(s)
- Xiaochen Zhang
- Department of Psychiatry, Taizhou Second People’s Hospital
| | - Yu Ren
- Department of Pharmacy, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
| | - Hua Luo
- Department of Orthopedic, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, Zhejiang, People’s Republic of China
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8
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Jiang W, Yan Y, Huang T, Lin Z, Yang X, Luo Z, Ye L. Efficacy and safety of aspirin in venous thromboembolism prevention after total hip arthroplasty, total knee arthroplasty or fracture. VASA 2024; 53:314-325. [PMID: 39052442 DOI: 10.1024/0301-1526/a001129] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 07/27/2024]
Abstract
Background: This study aims to analyse the efficacy and safety of aspirin in the prevention of venous thromboembolism (VTE) for patients undergoing total hip arthroplasty (THA), total knee arthroplasty (TKA) or fracture. Patients and methods: Two independent investigators searched PubMed, Embase, Cochrane and ClinicalTrials.gov from January 2000 to June 2023 to retrieve randomized control trials (RCTs) about aspirin in VTE prevention after arthroplasty or fracture. Then, the relative risk (RR) was utilized to evaluate its efficiency and safety. Results: A total of 16 RCTs with 27,864 patients were included. There was no statistical difference in the incidence of deep-vein thrombosis (RR: 1.31, p = 0.100), pulmonary embolism (RR:1.05, p = 0.850), VTE (RR:1.28, p = 0.290), major bleeding (RR:0.96, p = 0.900), and death (RR:1.01, p = 0.960) between the aspirin group and the anticoagulants group. Subgroup analysis showed that a relatively higher incidence of deep-vein thrombosis in patients undergoing TKA (RR:1.49, p = 0.030), fracture (RR:1.48, p = 0.001), patients receiving 81 mg aspirin twice daily (RR:1.48, p = 0.001) and patients from North America (RR:1.57, p<0.001) when comparing aspirin with anticoagulants. Meanwhile, the incidence of VTE was higher in patients receiving 100 mg aspirin once daily (RR:1.82, p<0.001) compared with anticoagulants. Additionally, the incidence of all bleeding (RR:2.00, p = 0.030) was higher in patients receiving aspirin in Asia compared with anticoagulants. Conclusions: In terms of clinical effectiveness and safety, aspirin (antiplatelet agent) was generally not inferior to anticoagulants in the prevention of VTE after THA, TKA, or fracture. Notably, the clinical effectiveness of aspirin was affected by different surgical types, the doses of aspirin and races.
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Affiliation(s)
- Wei Jiang
- Department of Intensive Care Unit, Ningbo No. 2 Hospital, Ningbo, Zhejiang, China
| | - Yici Yan
- The First School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, China
| | - Tongmin Huang
- The Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China
| | - Zhenyi Lin
- The First School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, China
| | - Xinyan Yang
- The First School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, China
| | - Zhouqing Luo
- The First School of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, China
| | - Lin Ye
- Department of Intensive Care Unit, Ningbo No. 2 Hospital, Ningbo, Zhejiang, China
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Cheok T, Beveridge A, Berman M, Coia M, Campbell A, Tse TTS, Doornberg JN, Jaarsma RL. Efficacy and safety of commonly used thromboprophylaxis agents following hip and knee arthroplasty. Bone Joint J 2024; 106-B:924-934. [PMID: 39216864 DOI: 10.1302/0301-620x.106b9.bjj-2023-1252.r2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/04/2024]
Abstract
Aims We investigated the efficacy and safety profile of commonly used venous thromboembolism (VTE) prophylaxis agents following hip and knee arthroplasty. Methods A systematic search of PubMed, Embase, Cochrane Library, Web of Science, and OrthoSearch was performed. Prophylaxis agents investigated were aspirin (< 325 mg and ≥ 325 mg daily), enoxaparin, dalteparin, fondaparinux, unfractionated heparin, warfarin, rivaroxaban, apixaban, and dabigatran. The primary efficacy outcome of interest was the risk of VTE, whereas the primary safety outcomes of interest were the risk of major bleeding events (MBE) and wound complications (WC). VTE was defined as the confirmed diagnosis of any deep vein thrombosis and/or pulmonary embolism. Network meta-analysis combining direct and indirect evidence was performed. Cluster rank analysis using the surface under cumulative ranking (SUCRA) was applied to compare each intervention group, weighing safety and efficacy outcomes. Results Of 86 studies eligible studies, cluster rank analysis showed that aspirin < 325 mg daily (SUCRA-VTE 89.3%; SUCRA-MBE 75.3%; SUCRA-WC 71.1%), enoxaparin (SUCRA-VTE 55.7%; SUCRA-MBE 49.8%; SUCRA-WC 45.2%), and dabigatran (SUCRA-VTE 44.9%; SUCRA-MBE 52.0%; SUCRA-WC 41.9%) have an overall satisfactory efficacy and safety profile. Conclusion We recommend the use of either aspirin < 325 mg daily, enoxaparin, or dabigatran for VTE prophylaxis following hip and knee arthroplasty.
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Affiliation(s)
- Tim Cheok
- Department of Orthopaedic Surgery, Lyell McEwin Hospital, Adelaide, Australia
- Department of Orthopaedic Surgery, Palmerston North Hospital, Palmerston North, New Zealand
- College of Medicine and Public Health, Flinders University, Adelaide, Australia
| | - Alexander Beveridge
- Department of Orthopaedic Surgery, Palmerston North Hospital, Palmerston North, New Zealand
- School of Medicine, Cardiff University, Neuadd Meirionnydd, Cardiff, UK
| | - Morgan Berman
- Department of Orthopaedic Surgery, Monash Medical Centre, Melbourne, Australia
| | - Martin Coia
- Department of Orthopaedic Surgery, Palmerston North Hospital, Palmerston North, New Zealand
| | - Alexander Campbell
- Department of Orthopaedic Surgery, Middlemore Hospital, Auckland, New Zealand
| | - Tycus T S Tse
- Department of Orthopaedic Surgery, Palmerston North Hospital, Palmerston North, New Zealand
| | - Job N Doornberg
- College of Medicine and Public Health, Flinders University, Adelaide, Australia
- Department of Orthopaedic Surgery, Flinders Medical Centre, Adelaide, Australia
- Department of Orthopaedic Surgery, University Medical Centre Groningen, Groningen, Netherlands
| | - Ruurd L Jaarsma
- College of Medicine and Public Health, Flinders University, Adelaide, Australia
- Department of Orthopaedic Surgery, Flinders Medical Centre, Adelaide, Australia
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10
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Liu KC, Bagrodia N, Richardson MK, Piple AS, Kusnezov N, Wang JC, Lieberman JR, Heckmann ND. Risk Factors Associated with Thromboembolic Complications After total Hip Arthroplasty: An Analysis of 1,129 Pulmonary Emboli. J Am Acad Orthop Surg 2024; 32:e706-e715. [PMID: 38626438 DOI: 10.5435/jaaos-d-23-01213] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/14/2023] [Accepted: 02/28/2024] [Indexed: 04/18/2024] Open
Abstract
INTRODUCTION Venous thromboembolism (VTE) remains a dangerous complication after total hip arthroplasty (THA), despite advances in chemoprophylactic measures. This study aimed to identify risk factors of developing pulmonary embolism (PE) and deep vein thrombosis (DVT) after THA using a modern cohort of patients reflecting contemporary practices. METHODS The Premier Healthcare Database was queried for primary, elective THAs from January 1st, 2015, to December 31st, 2021. Patients who developed PE or DVT within 90 days of THA were compared with patients who did not develop any postoperative VTE. Differences in patient demographics, comorbidities, hospital factors, perioperative medications, chemoprophylactic agents, and allogeneic blood transfusion were compared between cohorts. Multivariable logistic regression models were used to identify independent risk factors of PE and DVT. In total, 544,298 THAs were identified, of which 1,129 (0.21%) developed a PE and 1,799 (0.33%) developed a DVT. RESULTS Patients diagnosed with a PE had significantly higher rates of in-hospital death (2.6% vs 0.1%, P < 0.001) compared with those without a PE. Age (adjusted odds ratio: 1.02 per year, 95% confidence interval [CI]: 1.01 to 1.03) and Black race (aOR: 1.52, 95% CI: 1.24 to 1.87) were associated with an increased risk of PE. Comorbidities associated with increased risk of PE included chronic pulmonary disease (aOR: 1.58, 95% CI: 1.36 to 1.84), pulmonary hypertension (aOR: 2.06, 95% CI: 1.39 to 3.04), and history of VTE (aOR: 2.38, 95% CI: 1.98 to 2.86). Allogeneic blood transfusion (aOR: 2.40, 95% CI: 1.88 to 3.06) was also associated with an increased risk of PE while dexamethasone utilization was associated with a reduced risk (aOR: 0.83, 95% CI: 0.73 to 0.95). DISCUSSION Increasing age; Black race; allogeneic blood transfusion; and comorbidities, including chronic pulmonary disease, pulmonary hypertension, and history of VTE, were independent risk factors of PE after THA. Given the increased mortality associated with PE, patients should be carefully evaluated for these factors and managed with an appropriate chemoprophylactic regimen.
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Affiliation(s)
- Kevin C Liu
- From the Department of Orthopaedic Surgery, Keck School of Medicine of USC, Los Angeles, CA
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11
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Núñez JH, Moreira F, Escudero-Cisneros B, Martínez-Peña J, Bosch-García D, Angles F, Guerra-Farfán E. [Translated article] Risk of venous thromboembolism in thromboprophylaxis between aspirin and low molecular weight heparins after total hip arthroplasty or total knee arthroplasty: Systematic review and meta-analysis. Rev Esp Cir Ortop Traumatol (Engl Ed) 2024; 68:T409-T421. [PMID: 38325570 DOI: 10.1016/j.recot.2024.01.024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/15/2023] [Revised: 07/16/2023] [Accepted: 07/27/2023] [Indexed: 02/09/2024] Open
Abstract
INTRODUCTION The aim of this study was to evaluate the efficacy of aspirin versus low molecular weight heparins (LMWH) for the prophylaxis of venous thromboembolism (VTE), deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing total knee arthroplasty (TKA) and/or total hip arthroplasty (THA). MATERIALS AND METHODS Systematic review and meta-analysis. Sixteen studies were selected. The risk of VTE, DVT and PE were analysed. Mortality, risk of bleeding and surgical wound complications was also analysed. RESULTS 248,461 patients were included. 176,406 patients with thromboprophylaxis with LMWH and 72,055 patients with aspirin thromboprophylaxis. There were no significant differences in the risk of VTE (OR=0.93; 95% CI: 0.69-1.26; p=0.64), DVT (OR=0.72; 95% CI: 0.43-1.20; p=0.21) or PE (OR=1.13; 95% CI: 0.86-1.49; p=0.38) between both groups. No significant differences were found in mortality (p=0.30), bleeding (p=0.22), or complications in the surgical wound (p=0.85) between both groups. These same findings were found in the sub-analysis of only randomised clinical trials (p>0.05). CONCLUSIONS No increased risk of PE, DVT, or VTE was found among patients with aspirin thromboprophylaxis versus patients with LMWH thromboprophylaxis. There was also no greater mortality, greater bleeding, or greater complications in the surgical wound found among patients with aspirin thromboprophylaxis versus patients with LMWH thromboprophylaxis.
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Affiliation(s)
- J H Núñez
- Servicio de Traumatología y Cirugía Ortopédica, Hospital Universitario de Mutua Terrassa, Plaça del Doctor Robert, 5, 08221 Terrassa, Barcelona, Spain; Artro-Esport, Centro Médico Teknon, Carrer de Vilana, 12, 08022 Barcelona, Spain.
| | - F Moreira
- Artro-Esport, Centro Médico Teknon, Carrer de Vilana, 12, 08022 Barcelona, Spain
| | - B Escudero-Cisneros
- Servicio de Traumatología y Cirugía Ortopédica, Hospital Universitario de Mutua Terrassa, Plaça del Doctor Robert, 5, 08221 Terrassa, Barcelona, Spain
| | - J Martínez-Peña
- Servicio de Traumatología y Cirugía Ortopédica, Hospital Universitario de Mutua Terrassa, Plaça del Doctor Robert, 5, 08221 Terrassa, Barcelona, Spain
| | - D Bosch-García
- Servicio de Traumatología y Cirugía Ortopédica, Hospital Universitario de Mutua Terrassa, Plaça del Doctor Robert, 5, 08221 Terrassa, Barcelona, Spain
| | - F Angles
- Servicio de Traumatología y Cirugía Ortopédica, Hospital Universitario de Mutua Terrassa, Plaça del Doctor Robert, 5, 08221 Terrassa, Barcelona, Spain
| | - E Guerra-Farfán
- Artro-Esport, Centro Médico Teknon, Carrer de Vilana, 12, 08022 Barcelona, Spain
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Núñez JH, Moreira F, Escudero-Cisneros B, Martínez-Peña J, Bosch-García D, Anglès F, Guerra-Farfán E. Risk of venous thromboembolism in thromboprophylaxis between aspirin and low molecular weight heparins after total hip arthroplasty or total knee arthroplasty: Systematic review and meta-analysis. Rev Esp Cir Ortop Traumatol (Engl Ed) 2024; 68:409-421. [PMID: 37544408 DOI: 10.1016/j.recot.2023.07.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/15/2023] [Revised: 07/16/2023] [Accepted: 07/27/2023] [Indexed: 08/08/2023] Open
Abstract
INTRODUCTION The aim of this study was to evaluate the efficacy of aspirin versus low molecular weight heparins (LMWH) for the prophylaxis of venous thromboembolism (VTE), deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing total knee arthroplasty (TKA) and/or total hip arthroplasty (THA). MATERIALS AND METHODS Systematic review and meta-analysis. Sixteen studies were selected. The risk of VTE, DVT and PE were analyzed. Mortality, risk of bleeding and surgical wound complications was also analyzed. RESULTS 248,461 patients were included. 176,406 patients with thromboprophylaxis with LMWH and 72,055 patients with aspirin thromboprophylaxis. There were no significant differences in the risk of VTE (OR = 0.93; 95% CI: 0.69-1.26; P = .64), DVT (OR = 0.72; 95% CI: 0.43-1.20; P = .21) or PE (OR = 1.13; 95% CI: 0.86-1.49; P = .38) between both groups. No significant differences were found in mortality (P = .30), bleeding (P = .22), or complications in the surgical wound (P = .85) between both groups. These same findings were found in the sub-analysis of only randomized clinical trials (P>.05). CONCLUSIONS No increased risk of PE, DVT, or VTE was found among patients with aspirin thromboprophylaxis versus patients with LMWH thromboprophylaxis. There was also no greater mortality, greater bleeding, or greater complications in the surgical wound found among patients with aspirin thromboprophylaxis versus patients with LMWH thromboprophylaxis.
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Affiliation(s)
- Jorge H Núñez
- Servicio de Traumatología y Cirugía Ortopédica, Hospital Universitario de Mutua Terrassa, Terrassa, Barcelona, España; Artro-Esport, Centro Médico Teknon, Terrassa, Barcelona, España.
| | - Felipe Moreira
- Artro-Esport, Centro Médico Teknon, Terrassa, Barcelona, España
| | - Berta Escudero-Cisneros
- Servicio de Traumatología y Cirugía Ortopédica, Hospital Universitario de Mutua Terrassa, Terrassa, Barcelona, España
| | - Judith Martínez-Peña
- Servicio de Traumatología y Cirugía Ortopédica, Hospital Universitario de Mutua Terrassa, Terrassa, Barcelona, España
| | - David Bosch-García
- Servicio de Traumatología y Cirugía Ortopédica, Hospital Universitario de Mutua Terrassa, Terrassa, Barcelona, España
| | - Francesc Anglès
- Servicio de Traumatología y Cirugía Ortopédica, Hospital Universitario de Mutua Terrassa, Terrassa, Barcelona, España
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Wu H, Zhou L, Wang Q, Wang T, Liang S. Aspirin versus low-molecular-weight heparin for thromboprophylaxis after orthopaedic surgery: a systematic review and meta-analysis. Blood Coagul Fibrinolysis 2024; 35:187-195. [PMID: 38652521 PMCID: PMC11064920 DOI: 10.1097/mbc.0000000000001300] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2023] [Revised: 01/02/2024] [Accepted: 03/08/2024] [Indexed: 04/25/2024]
Abstract
The article aimed to compare the efficiency and safety of aspirin with low-molecular-weight heparin (LMWH) for thromboprophylaxis in orthopaedic surgery patients. According to the inclusion and exclusion criteria, PubMed, Embase and Cochrane Library database were searched for studies comparing aspirin and LMWH in venous thromboembolism (VTE) prophylaxis until 25 April 2023. The outcome measures included deep venous thrombosis(DVT)/Pulmonary embolism(PE) events, major bleeding events, wound complications, wound infection and death. Six studies met the requirements of our meta-analysis, including 12 470 patients in the aspirin group and 10 857 patients in the LMWH group. The meta-analysis showed that results showed that LMWH was superior to aspirin in preventing VTE events (odds ratio (OR) 1.44, 95% CI 1.24-1.68, P < 0.00001), whereas there was no significant difference between them in bleeding events (OR 0.95, 95% CI 0.86-1.05, P = 0.33), wound complication (OR 0.58, 95% CI 0.28-1.17, P = 0.13), wound infection (OR 1.12, 95% CI 0.86-1.47, P = 0.39) and mortality (OR 1.04, 95% CI 0.70-1.55, P = 0.83). In addition, subgroup analysis showed that compared with aspirin, LMWH was more likely to reduce the incidence of DVT events in orthopaedic surgery patients (OR 1.59, 95% CI 1.33-1.91, P < 0.00001), whereas there was no advantage in reducing the incidence of PE events (OR 1.22, 95% CI 0.62-2.40, P = 0.56). Despite the similar safety profiles, this meta-analysis showed that LMWH was significantly superior to aspirin in thromboprophylaxis after orthopaedic surgery. LMWH was still the first-line drug for thrombosis prevention in patients who underwent major orthopaedic surgeries.
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Affiliation(s)
- Haichao Wu
- Department of Vascular Surgery, Taizhou Municipal Hospital, Taizhou
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14
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Guo X, Zheng S, Zhi Y. Comment on 'The role of aspirin versus low-molecular-weight heparin for venous thromboembolism prophylaxis after total knee arthroplasty: a meta-analysis of randomized controlled trials'. Int J Surg 2024; 110:621-622. [PMID: 37800552 PMCID: PMC10793785 DOI: 10.1097/js9.0000000000000825] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2023] [Accepted: 09/24/2023] [Indexed: 10/07/2023]
Affiliation(s)
| | - Shuxian Zheng
- Blood Transfusion Department, The Sixth Affiliated Hospital of Xinjiang Medical University
| | - Yong Zhi
- College of Traditional Chinese Medicine, Xinjiang Medical University, Xinjiang, People’s Republic of China
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15
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Liu HZ, Liang J, Hu AX. The efficacy and safety of aspirin in preventing venous thrombosis in major orthopedic surgery: An updated meta-analysis of randomized controlled trials. Medicine (Baltimore) 2023; 102:e35602. [PMID: 37861503 PMCID: PMC10589573 DOI: 10.1097/md.0000000000035602] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/18/2023] [Accepted: 09/20/2023] [Indexed: 10/21/2023] Open
Abstract
BACKGROUND Major orthopedic surgery, including hip and knee replacement and lower extremity trauma fractures surgery, is associated with a high risk of venous thromboembolism (VTE), especially proximal deep vein thrombosis (DVT), and pulmonary embolism (PE), and is linked with high morbidity and mortality rates. Chemical anticoagulation is routinely used to prevent VTE, with previous meta-analyses reporting on the efficacy and safety of aspirin and other anticoagulants, however, opinions are divided. In the past 2 years, several large randomized controlled trials have been published, therefore, we reanalyzed aspirin efficacy and safety when compared with other anticoagulants in preventing VTE in major orthopedic surgery. METHODS Using PubMed, The Cochrane Library, Embase, and Web of Science databases, we conducted a RCT search in August 2023. The main outcomes included VTE, proximal DVT or PE. Additional outcomes included bleeding events, wound complications, wound infections, blood transfusions, and death events. RESULTS In total, 17 eligible articles, involving 29,522 patients (15,253 aspirin vs 14,269 other anticoagulant cases), were included. Primary outcomes showed that VTE incidence was more high in the aspirin group when compared with other anticoagulants (risk ratio [RR] = 1.45, 95% confidence interval [CI] = 1.18-1.77, P = .0004) and proximal in the aspirin group the DVT and/or PE incidence was significantly higher in the aspirin group when compared with other anticoagulants (RR = 1.19, 95% CI = 1.02-1.39, P = .03). No significant secondary outcome differences were identified in the aspirin group when compared with other anticoagulants (bleeding events [RR] = 0.83, 95% CI = 0.63-1.10, P = .20); wound complications (RR = 0.45, 95% CI = 0.20-1.04, P = .06); wound infection (RR = 1.08, 95% CI = 0.85-1.38, P = .53); blood transfusion events (RR = 1.00, 95% CI = 0.84-1.19, P = 1.00) and death events (RR = 1.11, 95% CI = 0.78-1.57, P = .55). CONCLUSIONS Our updated meta-analysis showed that aspirin was inferior to when compared with other anticoagulants in VTE-related orthopedic major surgery, including proximal DVT and/or PE, and was more likely to form VTE. No differences between groups were identified for bleeding, wound complications, wound infections, transfusion, or death events.
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Affiliation(s)
- Heng-Zhi Liu
- Department of Orthopaedics, The First College of Clinical Medical Science, China Three Gorges University, Yichang, China
- Department of Orthopaedics, Yichang Central People’s Hospital, Yichang, China
| | - Jie Liang
- Department of Orthopaedics, The First College of Clinical Medical Science, China Three Gorges University, Yichang, China
- Department of Orthopaedics, Yichang Central People’s Hospital, Yichang, China
| | - Ai-Xin Hu
- Department of Orthopaedics, The First College of Clinical Medical Science, China Three Gorges University, Yichang, China
- Department of Orthopaedics, Yichang Central People’s Hospital, Yichang, China
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Za P, Papalia GF, Franceschetti E, Rizzello G, Adravanti P, Papalia R. Aspirin is a safe and effective thromboembolic prophylaxis after total knee arthroplasty: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc 2023; 31:4407-4421. [PMID: 37449989 DOI: 10.1007/s00167-023-07500-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/24/2022] [Accepted: 07/03/2023] [Indexed: 07/18/2023]
Abstract
PURPOSE Patients undergoing total knee arthroplasty (TKA) are at high risk for thromboembolic events compared to non-surgical patients. Both anticoagulants and antiplatelet agents are used as antithrombotic prophylaxis in TKA. The aim of this review is to understand the role of aspirin in the prevention of thromboembolic events and to compare its efficacy and safety with the main anticoagulants used in antithromboembolic prophylaxis in TKA. METHODS A systematic review and meta-analysis was performed according to the PRISMA guidelines. An electronic systematic search was conducted using PubMed, Scopus, and the Cochrane Central Registry to evaluate studies that compared aspirin with other anticoagulants, in terms of deep venous thrombosis and pulmonary embolism after TKA. The meta-analysis compared the rate of complications between aspirin and other anticoagulants. RESULTS Thirteen studies were included in the systematic review for a total of 163,983 patients, and 10 studies were included in the meta-analysis. The meta-analysis demonstrated no statistically significant differences between aspirin and other anticoagulants in terms of the rate of deep venous thrombosis (OR 0.93, 95% CI 0.81-1.08, p = 0.35) and pulmonary embolism (OR 0.89, 95% CI 0.56-1.41, p = 0.61). CONCLUSION Aspirin is safe, effective, and not inferior to other main anticoagulants in preventing thromboembolic events following TKA.
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Affiliation(s)
- Pierangelo Za
- Department of Orthopaedic and Trauma Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128, Rome, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy
| | - Giuseppe Francesco Papalia
- Department of Orthopaedic and Trauma Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128, Rome, Italy.
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy.
| | - Edoardo Franceschetti
- Department of Orthopaedic and Trauma Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128, Rome, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy
| | - Giacomo Rizzello
- Department of Orthopaedic and Trauma Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128, Rome, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy
| | - Paolo Adravanti
- Department of Orthopaedic and Trauma Surgery, Casa di Cura Città of Parma, 43123, Parma, Italy
| | - Rocco Papalia
- Department of Orthopaedic and Trauma Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128, Rome, Italy
- Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy
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Jones A, Al-Horani RA. Venous Thromboembolism Prophylaxis in Major Orthopedic Surgeries and Factor XIa Inhibitors. Med Sci (Basel) 2023; 11:49. [PMID: 37606428 PMCID: PMC10443384 DOI: 10.3390/medsci11030049] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/12/2023] [Revised: 07/26/2023] [Accepted: 08/09/2023] [Indexed: 08/23/2023] Open
Abstract
Venous thromboembolism (VTE), comprising pulmonary embolism (PE) and deep vein thrombosis (DVT), poses a significant risk during and after hospitalization, particularly for surgical patients. Among various patient groups, those undergoing major orthopedic surgeries are considered to have a higher susceptibility to PE and DVT. Major lower-extremity orthopedic procedures carry a higher risk of symptomatic VTE compared to most other surgeries, with an estimated incidence of ~4%. The greatest risk period occurs within the first 7-14 days following surgery. Major bleeding is also more prevalent in these surgeries compared to others, with rates estimated between 2% and 4%. For patients undergoing major lower-extremity orthopedic surgery who have a low bleeding risk, it is recommended to use pharmacological thromboprophylaxis with or without mechanical devices. The choice of the initial agent depends on the specific surgery and patient comorbidities. First-line options include low-molecular-weight heparins (LMWHs), direct oral anticoagulants, and aspirin. Second-line options consist of unfractionated heparin (UFH), fondaparinux, and warfarin. For most patients undergoing knee or hip arthroplasty, the initial agents recommended for the early perioperative period are LMWHs (enoxaparin or dalteparin) or direct oral anticoagulants (rivaroxaban or apixaban). In the case of hip fracture surgery, LMWH is recommended as the preferred agent for the entire duration of prophylaxis. However, emerging factor XI(a) inhibitors, as revealed by a recent meta-analysis, have shown a substantial decrease in the occurrence of VTE and bleeding events among patients undergoing major orthopedic surgery. This discovery poses a challenge to the existing paradigm of anticoagulant therapy in this specific patient population and indicates that factor XI(a) inhibitors hold great promise as a potential strategy to be taken into serious consideration.
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Affiliation(s)
| | - Rami A. Al-Horani
- Division of Basic Pharmaceutical Sciences, College of Pharmacy, Xavier University of Louisiana, New Orleans, LA 70125, USA;
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18
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Nimerta F, Faisal S, Reyaz N, Shah SU, Gurajala S, Khenhrani RR, Khan MW, Amin A. Comparison of the Efficacy and Safety of Aspirin and Low-Molecular-Weight Heparin in Patients With a Fracture: A Meta-Analysis. Cureus 2023; 15:e39025. [PMID: 37323315 PMCID: PMC10265923 DOI: 10.7759/cureus.39025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 05/14/2023] [Indexed: 06/17/2023] Open
Abstract
The aim of this study is to compare the efficacy and safety of aspirin and low-molecular-weight heparin (LMWH) in preventing thromboembolic events in patients with fractures. The present meta-analysis was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched EMBASE, PubMed, and EBSCO to find articles comparing aspirin and LMWH in patients with orthopedic trauma from inception to April 15, 2023. Limits were set to studies published in the English language only. Outcomes assessed in this meta-analysis included VTE and all-cause mortality. VTE can manifest as deep venous thrombosis (DVT) and pulmonary embolism. For safety analysis, rates of wound complication, infection, and bleeding complications were compared between the two study groups. A total of three studies were included in this meta-analysis enrolling 12884 patients. The study found no significant difference between the two groups in the risk of DVT and pulmonary embolism, and aspirin was non-inferior to LMWH for the prevention of all-cause mortality in patients. Additionally, no significant safety risk was associated with aspirin thromboprophylaxis. These findings suggest that inexpensive over-the-counter aspirin is as effective as LMWH in terms of safety and efficacy profile, making it a feasible option to consider in clinical practice.
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Affiliation(s)
- Fnu Nimerta
- Medical College, Jinnah Sindh Medical University, Karachi, PAK
| | - Sana Faisal
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, California, USA
- Internal Medicine, Jinnah Sindh Medical University, Karachi, PAK
| | - Nafisa Reyaz
- Internal Medicine, Jawaharlal Nehru Medical College and Hospital, Aligarh, IND
| | | | - Swathi Gurajala
- Medical Microbiology, College of Applied Medical Sciences, Imam Abdul Rahman Bin Faisal University, Jubail, SAU
| | - Raja Ram Khenhrani
- Internal Medicine, Liaquat University of Medical and Health Sciences, Karachi, PAK
| | | | - Adil Amin
- Cardiology, PNS (Pakistan Navy Ship) Shifa, Karachi, PAK
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19
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Duke AJ, Bowen S, Baig S, Cohen D, Komatsu DE, Nicholson J. Thirty day low-dose versus regular-dose aspirin for venous thromboembolism prophylaxis in primary total joint arthroplasty. J Orthop Surg (Hong Kong) 2023; 31:10225536231173329. [PMID: 37137821 DOI: 10.1177/10225536231173329] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/05/2023] Open
Abstract
BACKGROUND The optimal dosing of aspirin (ASA) monotherapy for prophylaxis after total joint arthroplasty is debatable. The objective of this study was to compare two ASA regimens with regards to symptomatic deep venous thrombosis (DVT), pulmonary embolism (PE), bleeding, and infection 90 days after primary total hip arthroplasty (THA) and total knee arthroplasty (TKA). METHODS We retrospectively identified 625 primary THA and TKA surgeries in 483 patients who received ASA for 4 weeks post-op. 301 patients received 325 mg once daily (QD) and 324 patients received 81 mg twice daily (BID). Patients were excluded if they were minors, had a prior venous thromboembolism (VTE), had ASA allergy, or received other VTE prophylaxis drugs. RESULTS There was a significant difference in rate of bleeding and suture reactions between the two groups. Bleeding was 7.6% for 325 mg QD and 2.5% for 81 mg BID (p = .0029 Χ2, p = .004 on multivariate logistic regression analysis). Suture reactions were 3.3% for 325 mg QD and 1.2% for 81 mg BID (p = .010 Χ2, p = .027 on multivariate logistic regression analysis). Rates of VTE, symptomatic DVT, and PE were not significantly different. The incidence of VTE was 2.7% for 325 mg QD and 1.5% for 81 mg BID (p = .4056). Symptomatic DVT rates were 1.6% for 325 mg QD and 0.9% for 81 mg BID (p = .4139). Deep infection was 1.0% for 325 mg QD and 0.31% for 81 mg BID (p = .3564). CONCLUSION Low-dose ASA in patients with limited comorbidities undergoing primary THA and TKA is associated with significant lower rates of bleeding and suture reactions than high dose ASA. Low-dose ASA was not inferior to higher dose ASA for the prevention of VTE, wound complications, and infection 90 days postoperatively.
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Affiliation(s)
- Alexander J Duke
- Department of Orthopaedics and Rehabilitation, Stony Brook University, Stony Brook, NY, USA
| | - Stephen Bowen
- Department of Orthopaedics and Rehabilitation, Stony Brook University, Stony Brook, NY, USA
| | - Samir Baig
- Department of Orthopaedics and Rehabilitation, Stony Brook University, Stony Brook, NY, USA
| | - Dorian Cohen
- Department of Orthopaedics and Rehabilitation, Stony Brook University, Stony Brook, NY, USA
| | - David E Komatsu
- Department of Orthopaedics and Rehabilitation, Stony Brook University, Stony Brook, NY, USA
| | - James Nicholson
- Department of Orthopaedics and Rehabilitation, Stony Brook University, Stony Brook, NY, USA
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Statistical Fragility of Venous Thromboembolism Prophylaxis Following Total Joint Arthroplasty. Arthroplast Today 2023; 20:101111. [PMID: 36923060 PMCID: PMC10008837 DOI: 10.1016/j.artd.2023.101111] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/13/2022] [Revised: 12/25/2022] [Accepted: 01/22/2023] [Indexed: 03/18/2023] Open
Abstract
Background Statistical fragility is a quantitative measure of the robustness of the statistical conclusions drawn in a study. Although statistical fragility has been comprehensively evaluated in the arthroplasty literature, the statistical fragility of large-scale randomized trials evaluating venous thromboembolism (VTE) prophylaxis has not been evaluated. The purpose of this study was to determine the utility of applying the fragility index (FI) and the fragility quotient (FQ) analysis to randomized controlled trials (RCTs) evaluating VTE prophylaxis following total joint arthroplasty. Methods A systematic review was performed by searching multiple databases to identify RCTs that evaluated VTE prophylaxis following total joint arthroplasty from 2000 to 2020. The FI was determined by manipulating each reported dichotomous outcome event until a reversal of significance was appreciated with 2 × 2 contingency tables. The associated FQ was determined by dividing the FI by the sample size. Results Thirty-two RCTs were ultimately included for analysis. The overall FI incorporating all 32 RCTs was only 7 (interquartile range 3-9), suggesting that the reversal of only 7 events is required to change study significance. The associated FQ was determined to be 0.01. Of the RCTs that reported lost-to-follow-up data, the majority of studies had lost-to-follow-up numbers greater than 7. Conclusions Our findings suggest that RCTs evaluating VTE prophylaxis following total hip arthroplasty and total knee arthroplasty may lack statistical stability as few outcome events are required to reverse the significance of outcomes. Future randomized trials should consider reporting FI and FQ along with the P value analysis to provide better context to the integrity of statistical stability.
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Low Molecular Weight Heparin is Superior to Aspirin in the Prevention of Thromboembolic Disease, or is it? Response to an Editorial. J Arthroplasty 2023; 38:e7-e8. [PMID: 36906350 DOI: 10.1016/j.arth.2023.01.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/17/2022] [Revised: 11/29/2022] [Accepted: 01/04/2023] [Indexed: 03/13/2023] Open
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22
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O'Toole RV, Stein DM, O'Hara NN, Frey KP, Taylor TJ, Scharfstein DO, Carlini AR, Sudini K, Degani Y, Slobogean GP, Haut ER, Obremskey W, Firoozabadi R, Bosse MJ, Goldhaber SZ, Marvel D, Castillo RC. Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture. N Engl J Med 2023; 388:203-213. [PMID: 36652352 DOI: 10.1056/nejmoa2205973] [Citation(s) in RCA: 76] [Impact Index Per Article: 38.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/19/2023]
Abstract
BACKGROUND Clinical guidelines recommend low-molecular-weight heparin for thromboprophylaxis in patients with fractures, but trials of its effectiveness as compared with aspirin are lacking. METHODS In this pragmatic, multicenter, randomized, noninferiority trial, we enrolled patients 18 years of age or older who had a fracture of an extremity (anywhere from hip to midfoot or shoulder to wrist) that had been treated operatively or who had any pelvic or acetabular fracture. Patients were randomly assigned to receive low-molecular-weight heparin (enoxaparin) at a dose of 30 mg twice daily or aspirin at a dose of 81 mg twice daily while they were in the hospital. After hospital discharge, the patients continued to receive thromboprophylaxis according to the clinical protocols of each hospital. The primary outcome was death from any cause at 90 days. Secondary outcomes were nonfatal pulmonary embolism, deep-vein thrombosis, and bleeding complications. RESULTS A total of 12,211 patients were randomly assigned to receive aspirin (6101 patients) or low-molecular-weight heparin (6110 patients). Patients had a mean (±SD) age of 44.6±17.8 years, 0.7% had a history of venous thromboembolism, and 2.5% had a history of cancer. Patients received a mean of 8.8±10.6 in-hospital thromboprophylaxis doses and were prescribed a median 21-day supply of thromboprophylaxis at discharge. Death occurred in 47 patients (0.78%) in the aspirin group and in 45 patients (0.73%) in the low-molecular-weight-heparin group (difference, 0.05 percentage points; 96.2% confidence interval, -0.27 to 0.38; P<0.001 for a noninferiority margin of 0.75 percentage points). Deep-vein thrombosis occurred in 2.51% of patients in the aspirin group and 1.71% in the low-molecular-weight-heparin group (difference, 0.80 percentage points; 95% CI, 0.28 to 1.31). The incidence of pulmonary embolism (1.49% in each group), bleeding complications, and other serious adverse events were similar in the two groups. CONCLUSIONS In patients with extremity fractures that had been treated operatively or with any pelvic or acetabular fracture, thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin in preventing death and was associated with low incidences of deep-vein thrombosis and pulmonary embolism and low 90-day mortality. (Funded by the Patient-Centered Outcomes Research Institute; PREVENT CLOT ClinicalTrials.gov number, NCT02984384.).
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Affiliation(s)
- Robert V O'Toole
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Deborah M Stein
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Nathan N O'Hara
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Katherine P Frey
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Tara J Taylor
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Daniel O Scharfstein
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Anthony R Carlini
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Kuladeep Sudini
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Yasmin Degani
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Gerard P Slobogean
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Elliott R Haut
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - William Obremskey
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Reza Firoozabadi
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Michael J Bosse
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Samuel Z Goldhaber
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Debra Marvel
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
| | - Renan C Castillo
- From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.)
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Parvizi J, DeMik DE, Hozack WJ, Dunbar MJ, Mont MA, Lachiewicz PF. Low-Molecular-Weight Heparin Is Superior to Aspirin in the Prevention of Thromboembolic Disease: Or Is It? J Arthroplasty 2023; 38:1-2. [PMID: 36351554 DOI: 10.1016/j.arth.2022.09.017] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/12/2022] [Accepted: 09/13/2022] [Indexed: 11/09/2022] Open
Affiliation(s)
- Javad Parvizi
- Rothman Orthopaedic Institute, Philadelphia, Pennsylvania
| | - David E DeMik
- Rothman Orthopaedic Institute, Philadelphia, Pennsylvania
| | | | | | - Michael A Mont
- Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, Baltimore, Maryland
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Singjie LC, Halomoan R, Saleh I, Sumargono E, Kholinne E. Clinical effectiveness and safety of aspirin and other anticoagulants for venous thromboembolism prophylaxis after major orthopedic surgery: a systematic review and meta-analysis of randomized clinical trials. EFORT Open Rev 2022; 7:792-799. [PMID: 36541528 PMCID: PMC9880907 DOI: 10.1530/eor-22-0053] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2022] Open
Abstract
Purpose Patients undergoing major orthopedic surgeries, such as total hip replacement (THR), total knee replacement (TKR), and trauma surgery, are at an elevated risk of venous thromboembolism (VTE), causing significant morbidity and mortality. Previous studies have investigated aspirin as a thromboprophylactic agent for arthroplasty, besides trauma surgery. Therefore, we sought to analyze the efficacy of aspirin compared to that of other anticoagulants for VTE prophylaxis in patients undergoing major orthopedic surgeries. Methods This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The study protocol was registered with the PROSPERO register. Randomized controlled trials that investigated the use of aspirin for thromboprophylaxis in major orthopedic lower limb surgeries were included and analyzed. Quality analysis of the literature and level of evidence were assessed. The primary clinical outcome was VTE. Secondary clinical outcomes included mortality, bleeding events, and wound complications. Results Eight high-quality studies with level 2 evidence (published within 2006-2021) were included, comprising 6220 patients. The incidence of VTE with aspirin was not found to be more significant than other anticoagulants (risk ratio (RR) = 1.18, 95% CI: 0.89-1.58, P = 0.25). Regarding secondary outcomes, there were no significant differences between aspirin and other anticoagulants (mortality (RR = 1.40, 95% CI: 0.27-7.23, P = 0.69), bleeding events (RR = 0.89, 95% CI: 0.57-1.39, P = 0.61), or wound complications (RR = 0.64, 95% CI: 0.30-1.35, P = 0.24)). Conclusion The current meta-analysis did not show any difference between aspirin and other anticoagulants as thromboprophylactic agents in preventing VTE in patients who underwent major orthopedic surgeries.
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Affiliation(s)
- Leonard Christianto Singjie
- Department of Orthopedic Surgery, St. Carolus Hospital, Jakarta, Indonesia
- Faculty of Medicine, Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia
| | - Reynaldo Halomoan
- Faculty of Medicine, Atma Jaya Catholic University of Indonesia, Jakarta, Indonesia
| | - Ifran Saleh
- Department of Orthopedic Surgery, St. Carolus Hospital, Jakarta, Indonesia
- Faculty of Medicine, University of Indonesia, Jakarta, Indonesia
| | | | - Erica Kholinne
- Department of Orthopedic Surgery, St. Carolus Hospital, Jakarta, Indonesia
- Faculty of Medicine, Universitas Trisakti, Jakarta, Indonesia
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Parvizi J, DeMik DE, Dunbar M, Hozack WJ, Mont MA, Lachiewicz PF. Low-Molecular-Weight Heparin Is Superior to Aspirin in the Prevention of Thromboembolic Disease: Or Is It? J Bone Joint Surg Am 2022; 104:2045-2046. [PMID: 36476736 DOI: 10.2106/jbjs.22.01024] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Affiliation(s)
- Javad Parvizi
- Rothman Orthopaedic Institute, Philadelphia, Pennsylvania
| | - David E DeMik
- Rothman Orthopaedic Institute, Philadelphia, Pennsylvania
| | | | | | - Michael A Mont
- Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, Baltimore, Maryland
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Kakkos S, Kirkilesis G, Caprini JA, Geroulakos G, Nicolaides A, Stansby G, Reddy DJ. Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism. Cochrane Database Syst Rev 2022; 1:CD005258. [PMID: 35089599 PMCID: PMC8796751 DOI: 10.1002/14651858.cd005258.pub4] [Citation(s) in RCA: 26] [Impact Index Per Article: 8.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
BACKGROUND It is generally assumed by practitioners and guideline authors that combined modalities (methods of treatment) are more effective than single modalities in preventing venous thromboembolism (VTE), defined as deep vein thrombosis (DVT) or pulmonary embolism (PE), or both. This is the second update of the review first published in 2008. OBJECTIVES The aim of this review was to assess the efficacy of combined intermittent pneumatic leg compression (IPC) and pharmacological prophylaxis compared to single modalities in preventing VTE. SEARCH METHODS The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases, and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 18 January 2021. We searched the reference lists of relevant articles for additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) or controlled clinical trials (CCTs) of combined IPC and pharmacological interventions used to prevent VTE compared to either intervention individually. DATA COLLECTION AND ANALYSIS We independently selected studies, applied Cochrane's risk of bias tool, and extracted data. We resolved disagreements by discussion. We performed fixed-effect model meta-analyses with odds ratios (ORs) and 95% confidence intervals (CIs). We used a random-effects model when there was heterogeneity. We assessed the certainty of the evidence using GRADE. The outcomes of interest were PE, DVT, bleeding and major bleeding. MAIN RESULTS We included a total of 34 studies involving 14,931 participants, mainly undergoing surgery or admitted with trauma. Twenty-five studies were RCTs (12,672 participants) and nine were CCTs (2259 participants). Overall, the risk of bias was mostly unclear or high. We used GRADE to assess the certainty of the evidence and this was downgraded due to the risk of bias, imprecision or indirectness. The addition of pharmacological prophylaxis to IPC compared with IPC alone reduced the incidence of symptomatic PE from 1.34% (34/2530) in the IPC group to 0.65% (19/2932) in the combined group (OR 0.51, 95% CI 0.29 to 0.91; 19 studies, 5462 participants, low-certainty evidence). The incidence of DVT was 3.81% in the IPC group and 2.03% in the combined group showing a reduced incidence of DVT in favour of the combined group (OR 0.51, 95% CI 0.36 to 0.72; 18 studies, 5394 participants, low-certainty evidence). The addition of pharmacological prophylaxis to IPC, however, increased the risk of any bleeding compared to IPC alone: 0.95% (22/2304) in the IPC group and 5.88% (137/2330) in the combined group (OR 6.02, 95% CI 3.88 to 9.35; 13 studies, 4634 participants, very low-certainty evidence). Major bleeding followed a similar pattern: 0.34% (7/2054) in the IPC group compared to 2.21% (46/2079) in the combined group (OR 5.77, 95% CI 2.81 to 11.83; 12 studies, 4133 participants, very low-certainty evidence). Tests for subgroup differences between orthopaedic and non-orthopaedic surgery participants were not possible for PE incidence as no PE events were reported in the orthopaedic subgroup. No difference was detected between orthopaedic and non-orthopaedic surgery participants for DVT incidence (test for subgroup difference P = 0.19). The use of combined IPC and pharmacological prophylaxis modalities compared with pharmacological prophylaxis alone reduced the incidence of PE from 1.84% (61/3318) in the pharmacological prophylaxis group to 0.91% (31/3419) in the combined group (OR 0.46, 95% CI 0.30 to 0.71; 15 studies, 6737 participants, low-certainty evidence). The incidence of DVT was 9.28% (288/3105) in the pharmacological prophylaxis group and 5.48% (167/3046) in the combined group (OR 0.38, 95% CI 0.21 to 0.70; 17 studies; 6151 participants, high-certainty evidence). Increased bleeding side effects were not observed for IPC when it was added to anticoagulation (any bleeding: OR 0.87, 95% CI 0.56 to 1.35, 6 studies, 1314 participants, very low-certainty evidence; major bleeding: OR 1.21, 95% CI 0.35 to 4.18, 5 studies, 908 participants, very low-certainty evidence). No difference was detected between the orthopaedic and non-orthopaedic surgery participants for PE incidence (test for subgroup difference P = 0.82) or for DVT incidence (test for subgroup difference P = 0.69). AUTHORS' CONCLUSIONS Evidence suggests that combining IPC with pharmacological prophylaxis, compared to IPC alone reduces the incidence of both PE and DVT (low-certainty evidence). Combining IPC with pharmacological prophylaxis, compared to pharmacological prophylaxis alone, reduces the incidence of both PE (low-certainty evidence) and DVT (high-certainty evidence). We downgraded due to risk of bias in study methodology and imprecision. Very low-certainty evidence suggests that the addition of pharmacological prophylaxis to IPC increased the risk of bleeding compared to IPC alone, a side effect not observed when IPC is added to pharmacological prophylaxis (very low-certainty evidence), as expected for a physical method of thromboprophylaxis. The certainty of the evidence for bleeding was downgraded to very low due to risk of bias in study methodology, imprecision and indirectness. The results of this update agree with current guideline recommendations, which support the use of combined modalities in hospitalised people (limited to those with trauma or undergoing surgery) at risk of developing VTE. More studies on the role of combined modalities in VTE prevention are needed to provide evidence for specific patient groups and to increase our certainty in the evidence.
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Affiliation(s)
- Stavros Kakkos
- Department of Vascular Surgery, University of Patras Medical School, Patras, Greece
| | - George Kirkilesis
- Department of Vascular Surgery, University of Patras Medical School, Patras, Greece
| | - Joseph A Caprini
- NorthShore University HealthSystem, Evanston, Illinois, USA
- Pritzker School of Medicine, Chicago, Illinois, USA
| | - George Geroulakos
- Department of Surgery and Cancer, Imperial College of Science Technology and Medicine, London, UK
- Department of Vascular Surgery, Attikon University Hospital, National and Kapodistrian University, Athens, Greece
| | - Andrew Nicolaides
- Department of Surgery, University of Nicosia Medical School, Nicosia, Cyprus
| | - Gerard Stansby
- Northern Vascular Centre, Freeman Hospital, Newcastle, UK
| | - Daniel J Reddy
- Department of Surgery, Wayne State University, Detroit, Michigan, USA
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Major Orthopedic Surgery. Perioper Med (Lond) 2022. [DOI: 10.1016/b978-0-323-56724-4.00034-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
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Matzko C, Berliner ZP, Husk G, Mina B, Nisonson B, Hepinstall MS. Equivalent VTE rates after total joint arthroplasty using thromboprophylaxis with aspirin versus potent anticoagulants: retrospective analysis of 4562 cases across a diverse healthcare system. ARTHROPLASTY 2021; 3:45. [PMID: 35236505 PMCID: PMC8796388 DOI: 10.1186/s42836-021-00101-8] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/30/2021] [Accepted: 09/24/2021] [Indexed: 12/21/2022] Open
Abstract
BACKGROUND Guidelines support aspirin thromboprophylaxis for primary total hip and knee arthroplasty (THA and TKA) but supporting evidence has come from high volume centers and the practice remains controversial. METHODS We studied 4562 Medicare patients who underwent elective primary THA (1736, 38.1%) or TKA (2826, 61.9%) at 9 diverse hospitals. Thirty-day claims data were combined with data from the health system's electronic medical records to compare rates of venous thromboembolism (VTE) between patients who received prophylaxis with: (1) aspirin alone (47.3%), (2) a single, potent anticoagulant (29%), (3) antiplatelet agents other than aspirin or multiple anticoagulants (21.5%), or (4) low-dose subcutaneous unfractionated heparin or no anticoagulation (2.2%). Sub-analyses separately evaluating THA, TKA and cases from lower volume hospitals (n = 975) were performed. RESULTS The 30-day VTE incidence was 0.6% (29/4562). VTE rates were equal in patients receiving aspirin and those receiving a single potent anticoagulant (0.5% in both groups). Patients with VTE were significantly older than patients without VTE (mean 76.5 vs. 73.1 years, P = 0.04). VTE rate did not associate with sex or hospital case volume. On bivariate analysis considering age, aspirin did not associate with greater VTE risk compared to a single potent anticoagulant (OR = 2.1, CI = 0.7-6.3) with the numbers available. Odds of VTE were increased with use of subcutaneous heparin or no anticoagulant (OR = 6.4, CI = 1.2-35.6) and with multiple anticoagulants (OR = 3.6, CI = 1.1-11.2). THA and TKA demonstrated similar rates of VTE (0.5% vs. 0.7%, respectively, P = 0.43). Of 975 cases done at lower volume hospitals, 387 received aspirin, none of whom developed VTE. CONCLUSIONS This study provides further support for aspirin as an effective form of pharmacological VTE prophylaxis after total joint arthroplasty in the setting of a multi-modal regimen using 30-day outcomes. VTE occurred in 0.7% of primary joint arthroplasties. Aspirin prophylaxis did not associate with greater VTE risk compared to potent anticoagulants in the total population or at lower volume hospitals.
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Affiliation(s)
- Chelsea Matzko
- Department of Orthopedic Surgery, Lenox Hill Hospital, Northwell Health, New York, New York, USA
| | - Zachary P Berliner
- Department of Orthopedic Surgery, Lenox Hill Hospital, Northwell Health, New York, New York, USA.,Department of Orthopedic Surgery, Boston University Medical Center, Boston, Massachusetts, USA
| | - Gregg Husk
- Department of Orthopedic Surgery, Lenox Hill Hospital, Northwell Health, New York, New York, USA
| | - Bushra Mina
- Department of Orthopedic Surgery, Lenox Hill Hospital, Northwell Health, New York, New York, USA
| | - Barton Nisonson
- Department of Orthopedic Surgery, Lenox Hill Hospital, Northwell Health, New York, New York, USA
| | - Matthew S Hepinstall
- Department of Orthopedic Surgery, Lenox Hill Hospital, Northwell Health, New York, New York, USA. .,Department of Orthopedic Surgery, NYU Langone Health, 301 E 17th St, Suite 1402, New York, 10003, New York, USA.
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Halbur CR, Gulbrandsen TR, West CR, Brown TS, Noiseux NO. Weight-Based Aspirin Dosing May Further Reduce the Incidence of Venous Thromboembolism Following Primary Total Joint Arthroplasty. J Arthroplasty 2021; 36:3986-3992.e1. [PMID: 34215460 DOI: 10.1016/j.arth.2021.06.008] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/30/2021] [Revised: 05/29/2021] [Accepted: 06/08/2021] [Indexed: 02/02/2023] Open
Abstract
BACKGROUND Obesity poses a challenge to thromboembolic prophylaxis following total joint arthroplasty (TJA). The purpose of this study is to evaluate a weight-based aspirin dosing regimen for prevention of venous thromboembolism (VTE) following TJA. METHODS This is a retrospective observational study of 2403 patients who underwent primary total hip or knee arthroplasty at one institution. A weight-based aspirin dosing regimen for VTE prophylaxis was administered to 1247 patients: patients weighing ≥120 kg received 325 mg aspirin twice daily (BID) and those weighing <120 kg received 81 mg aspirin BID for 4 weeks. In total, 1156 patients in the comparison cohort received 81 mg aspirin BID. VTE and gastrointestinal bleeding events were identified through chart review at 42 days and 6 months postoperatively. A multivariable logistic regression was performed to adjust for covariates. RESULTS The weight-based aspirin cohort had a significantly lesser incidence of VTE at 42 days (P = .03, relative risk [RR] 0.31, 95% confidence interval 0.12-0.82) and 6 months (P = .03, RR 0.38, 95% confidence interval 0.18-0.80). There was no difference in VTE incidence between total hip arthroplasty and total knee arthroplasty cases (P = .8). There was no difference in gastrointestinal bleeding events between the cohorts at 42 days (P = .69) or 6 months (P = .92). Subanalysis of patients weighing ≥120 kg demonstrated a significant difference between the cohorts with a VTE incidence of 3.48% and 0% in the 81 mg and weight-based cohorts, respectively (P = .02). CONCLUSION Patients prescribed a weight-based aspirin regimen had significantly fewer VTEs after TJA compared to historical controls with an RR reduction of 69% at 6 weeks and 62% at 6 months postoperatively. This suggests the need to factor patient weight when determining postoperative VTE prophylaxis with aspirin.
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Affiliation(s)
- Christopher R Halbur
- Department of Orthopedic Surgery and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA
| | - Trevor R Gulbrandsen
- Department of Orthopedic Surgery and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA
| | | | - Timothy S Brown
- Department of Orthopedic Surgery and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA
| | - Nicolas O Noiseux
- Department of Orthopedic Surgery and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA
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31
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Hovik O, Amlie EJ, Jenssen KK. No Increased Risk of Venous Thromboembolism in High-Risk Patients Continuing Their Dose of 75 mg Aspirin Compared to Healthier Patients Given Low-Molecular-Weight Heparin. J Arthroplasty 2021; 36:3589-3592. [PMID: 34176693 DOI: 10.1016/j.arth.2021.06.001] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/26/2021] [Revised: 05/11/2021] [Accepted: 06/06/2021] [Indexed: 02/02/2023] Open
Abstract
BACKGROUND Optimum venous thromboembolism (VTE) prophylaxis for patients undergoing total hip or knee arthroplasty remains undefined. The purpose of this study is to compare complication rates among total joint arthroplasty patients using either low-dose aspirin (75 mg once daily) or low-molecular-weight heparin (LMWH; Fragmin/dalteparin 5000 U) for VTE prophylaxis. METHODS This is a prospective observational study. All total hip or knee arthroplasties from 2014 to 2020 were included. One thousand eighty-four patients already taking aspirin 75 mg as primary or secondary prophylaxis for cardiovascular disease continued their daily aspirin dose throughout their hospital stay and after discharge without any other kind of thromboprophylaxis. Five thousand ten patients not already taking aspirin were given LMWH for 12-14 days starting the day of surgery. Both groups consisted of patients undergoing either primary or revision total hip or knee arthroplasty. The aspirin group was older (73 ± 7.8 vs 66 ± 10.2 years, P < .01, 95% CI -7.6, -6.3) with more comorbidities but otherwise did not differ from the LMWH group. Outcome measures were recorded at 3-month follow-up and included the following complications: clinically deep venous thrombosis (DVT), pulmonary embolism (PE), deep infection, blood transfusion, and death. RESULTS The aspirin group had 0.28% DVT and 0.28% PE, and the LMWH group had 0.24% DVT and 0.16% PE (P = .42 and .74, respectively). No difference in deep infection, allogenic blood transfusion, or mortality was found. CONCLUSION No statistically significant difference in complication rates was found between aspirin 75 mg and LMWH used for VTE prophylaxis. Aspirin 75 mg daily is safe for VTE prophylaxis after total hip or knee arthroplasty.
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Affiliation(s)
- Oystein Hovik
- Orthopaedic Department, Lovisenberg Diaconal Hospital, Oslo, Norway
| | - Einar J Amlie
- Orthopaedic Department, Lovisenberg Diaconal Hospital, Oslo, Norway
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Marrannes S, Victor K, Arnout N, De Backer T, Victor J, Tampere T. Prevention of venous thromboembolism with aspirin following knee surgery: A systematic review and meta-analysis. EFORT Open Rev 2021; 6:892-904. [PMID: 34760289 PMCID: PMC8559566 DOI: 10.1302/2058-5241.6.200120] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/24/2022] Open
Abstract
Venous thromboembolism (VTE) is a well-known complication following orthopaedic surgery. The incidence of this complication has decreased substantially since the introduction of routine thromboprophylaxis. However, concerns have been raised about increased bleeding complications caused by aggressive thromboprophylaxis.Attention has grown for aspirin as a safer thromboprophylactic agent following orthopaedic surgery.A systematic review using MEDLINE, Embase and Web of Science databases was undertaken to compare the effectiveness of aspirin prophylaxis following knee surgery with the current standard prophylactic agents (low molecular weight heparin [LMWH], vitamin K antagonists and factor Xa inhibitors).No significant difference in effectiveness of VTE prevention was found between aspirin, LMWH and warfarin. Factor Xa inhibitors were more effective, but increased bleeding complications were reported.As evidence is limited and of low quality with substantial heterogeneity, further research with high-quality, adequately powered trials is needed. Cite this article: EFORT Open Rev 2021;6:892-904. DOI: 10.1302/2058-5241.6.200120.
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Affiliation(s)
| | - Klaas Victor
- Department of Orthopedic Surgery, University of Leuven, Belgium
| | - Nele Arnout
- Department of Orthopedic Surgery, Ghent University, Belgium
| | | | - Jan Victor
- Department of Orthopedic Surgery, Ghent University, Belgium
| | - Thomas Tampere
- Department of Orthopedic Surgery, Ghent University, Belgium
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Farey JE, An VVG, Sidhu V, Karunaratne S, Harris IA. Aspirin versus enoxaparin for the initial prevention of venous thromboembolism following elective arthroplasty of the hip or knee: A systematic review and meta-analysis. Orthop Traumatol Surg Res 2021; 107:102606. [PMID: 32631716 DOI: 10.1016/j.otsr.2020.04.002] [Citation(s) in RCA: 27] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/23/2020] [Revised: 04/07/2020] [Accepted: 04/08/2020] [Indexed: 02/03/2023]
Abstract
BACKGROUND Aspirin is perceived to be non-inferior to enoxaparin, a low-molecular-weight heparin, for the prevention of venous thromboembolism (VTE) following elective arthroplasty of the hip or knee and is recommended in clinical guidelines internationally. Previous systematic reviews of aspirin as VTE prophylaxis have been limited by the inclusion of heterogenous studies where aspirin is commenced after the initial high-risk postoperative period. The purpose of this systematic review and meta-analysis was to compare the efficacy and associated harms of aspirin and enoxaparin when used as VTE prophylaxis in the initial postoperative period following elective arthroplasty of the hip or knee. We sought to: (1) to compare the use of aspirin versus enoxaparin following elective joint replacement of the hip or knee on the primary outcomes of incidence of VTE and mortality up to 3 months postoperatively and (2) assess the efficacy of aspirin with respect to secondary outcomes such as major or minor bleeding events. We hypothesised that aspirin would have equivalent efficacy for the prevention of VTE when used as initial prophylactic agent, without increasing harm from bleeding events. PATIENTS AND METHODS We searched Pubmed, Embase, Medline and Cochrane Central for randomized controlled trials reporting the primary outcomes of VTE incidence and mortality. Secondary outcomes included major (compromise of organ, limb or muscle function requiring unplanned re-operation) and minor bleeding events (wound ooze, minor bleed, infection). Included trials underwent a risk of bias and quality of evidence assessment using the GRADE criteria. RESULTS Four trials involving 1507 participants who underwent elective lower limb arthroplasty were included. We did not detect a significant difference in overall VTE rates when comparing aspirin versus enoxaparin (RR, 0.84; 95% CI: 0.41 to 1.75; p=0.65). Mortality was reported by one study and no events were recorded. There were no significant differences in the rates of all major (RR, 0.84; 95% CI: 0.08 to 9.16) or minor (RR, 0.77; 95% CI: 0.34 to 1.72) bleeding events between the aspirin and enoxaparin groups. Included trials demonstrated a significant risk of bias, and Low to Very Low quality of evidence for primary outcomes, and Moderate to Very Low for secondary outcomes. CONCLUSION There is currently a lack of high quality randomised controlled trials supporting the use of aspirin as VTE chemoprophylaxis in the initial postoperative period for both total hip and total knee arthroplasty. The results of this meta-analysis provide cautious endorsement for the position that aspirin is likely a safe alternative to enoxaparin for TKA patients as part of a multimodal enhanced recovery protocol, but care is advised for THA patients owing to a lack of data from trials. Current evidence from randomized controlled trials is generally of low quality, and does not estimate critical event data for VTE incidence or mortality, as well as major and minor bleeding events with sufficient certainty. PROSPERO Registration CRD42018110784. LEVEL OF EVIDENCE II, systematic review.
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Affiliation(s)
- John E Farey
- Department of Orthopaedic Surgery, Royal Prince Alfred Hospital, Missenden Road, 2050 Camperdown NSW, Australia.
| | - Vincent V G An
- Department of Orthopaedic Surgery, Royal Prince Alfred Hospital, Missenden Road, 2050 Camperdown NSW, Australia
| | - Verinder Sidhu
- School of Public Health, Institute for Musculoskeletal Health, University of Sydney, King George V building, Missenden Road, 2050 Camperdown NSW, Australia
| | - Sascha Karunaratne
- Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Missenden Road, 2050 Camperdown NSW, Australia
| | - Ian A Harris
- Department of Orthopaedic Surgery, Royal Prince Alfred Hospital, Missenden Road, 2050 Camperdown NSW, Australia; School of Public Health, Institute for Musculoskeletal Health, University of Sydney, King George V building, Missenden Road, 2050 Camperdown NSW, Australia; South Western Sydney Clinical School, Ingham Institute for Applied Medical Research, University of New South Wales, 1,Campbell Street, 2170 Liverpool NSW, Australia
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34
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Analysis of the quality of reporting of randomized controlled trials in anticoagulant versus antiplatelet medication for venous thromboembolism prophylaxis as governed by the CONSORT statement. J Thromb Thrombolysis 2020; 52:138-147. [PMID: 33068278 DOI: 10.1007/s11239-020-02315-0] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 10/09/2020] [Indexed: 12/19/2022]
Abstract
Randomized controlled trials (RCTs) are the gold standard research in evaluating healthcare interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement improves the quality of RCTs in an evidence-based approach. To evaluate the reporting quality of published RCTs concerning the use of anticoagulants versus antiplatelet agents for venous thromboembolism prophylaxis according to the CONSORT statement. Electronic databases were searched for English-language RCTs involving patients who received either anticoagulant or antiplatelet medication for prophylaxis of deep vein thrombosis and pulmonary embolism published from 2000 to 2019. Trials were considered eligible when the included patients received either anticoagulant or antiplatelet medication for primary and secondary prevention of deep vein thrombosis or pulmonary embolism and were randomly assigned to at least two treatment arms. Quality of reporting was assessed using a 37-item questionnaire based on the CONSORT 2010 checklist. Reporting was assessed in 2 publication periods (2000-2009) and (2010-2019). The effect of CONSORT statement in high- and low-ranked medical journals, according to their impact factor, has also been evaluated. The search identified 13 eligible articles for analysis. Only 12 of the 37 items of the checklist were addressed in 75% or more of the studies. Most items concerning the methodological issues were reported by fewer than 50% of the studies. Improvements over time were seen for items that assessed the methodological quality with no statistically significant difference. RCTs published in high-ranked journals showed better quality of reporting. Quality of reporting in RCTs focusing on the use of anticoagulants versus antiplatelet agents for venous thromboembolism prophylaxis remains unsatisfactory. Further improvement of reporting is necessary to assess the validity of clinical research.
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Ní Cheallaigh S, Fleming A, Dahly D, Kehoe E, O'Byrne JM, McGrath B, O'Connell C, Sahm LJ. Aspirin compared to enoxaparin or rivaroxaban for thromboprophylaxis following hip and knee replacement. Int J Clin Pharm 2020; 42:853-860. [PMID: 32328957 DOI: 10.1007/s11096-020-01032-1] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2019] [Accepted: 04/08/2020] [Indexed: 11/29/2022]
Abstract
Background The risk of venous thromboembolism following major orthopaedic surgery is among the highest for all surgical specialties. Our hospital guidelines for thromboprophylaxis following elective primary total hip or knee replacement are based on American College of Chest Physicians guidance. The most recent change to local guidelines was the introduction of the extended aspirin regimen as standard thromboprophylaxis. Objective To establish the appropriateness of this regimen by comparing venous thromboembolism rates in patients receiving extended aspirin to previous regimens. Setting The largest dedicated orthopaedic hospital in Ireland. Methods This was a retrospective cohort study. Data were collected from patient record software. All eligible patients undergoing primary total hip or knee replacement between 1st January 2010 and 30th June 2016 were included. Main outcome measure Venous thromboembolism up to 6 months post-operatively. Results Of the 6548 participants (55.3% female, mean age 65.4 years (± 11.8 years, 55.8% underwent total hip replacement), venous thromboembolism occurred in 65 (0.99%). Venous thromboembolism rate in both the inpatient enoxaparin group (n = 961) and extended aspirin group (n = 3460) was 1.04% and was 0.66% in the modified rivaroxaban group (n = 1212). Non-inferiority analysis showed the extended aspirin regimen to be equivalent to the modified rivaroxaban regimen. History of venous thromboembolism was the only significant demographic risk factor for post-operative venous thromboembolism (0.87% vs. 3.54%, p = 0.0002). Conclusion In daily clinical practice, extended aspirin regimen is at least as effective as modified rivaroxaban for preventing clinically important venous thromboembolism among patients undergoing hip or knee arthroplasty who are discharged from the hospital without complications. Aspirin can be considered a safe and effective agent in the prevention of venous thromboembolism after total hip or total knee replacement.
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Affiliation(s)
| | - Aoife Fleming
- Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Cork, Ireland
| | - Darren Dahly
- HRB Clinical Research Facility Cork, School of Public Health, University College Cork, Cork, Ireland
| | - Eimear Kehoe
- Pharmacy Department, Cappagh National Orthopaedic Hospital, Dublin 11, Ireland
| | - John M O'Byrne
- RCSI Department of Orthopaedic Surgery, Cappagh National Orthopaedic Hospital, Dublin 11, Ireland
| | - Brid McGrath
- Department of Anaesthetics, Cappagh National Orthopaedic Hospital, Dublin 11, Ireland
| | - Charles O'Connell
- Pharmacy Department, Cappagh National Orthopaedic Hospital, Dublin 11, Ireland
| | - Laura J Sahm
- Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Cork, Ireland.
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36
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An VVG, Levy YD, Walker PM, Bruce WJ. Thrombosis rates using aspirin and a compression device as multimodal prophylaxis for lower limb arthroplasty in a screened population. J Clin Orthop Trauma 2020; 11:S187-S191. [PMID: 32189937 PMCID: PMC7067987 DOI: 10.1016/j.jcot.2018.10.007] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/14/2018] [Revised: 10/11/2018] [Accepted: 10/15/2018] [Indexed: 10/28/2022] Open
Abstract
BACKGROUND Venous thromboembolism (VTE) (Deep vein thrombosis (DVT), and pulmonary embolism (PE)), is a common complication in patients undergoing total joint arthroplasty (TJA). Recently, aspirin was recommended by the American Academy of Orthopaedic Surgeons (AAOS) as VTE prophylaxis following TJA. This study investigates VTE rates in TJA patients using as thromboprophylaxis. METHODS DVT was screened for in 396 consecutive total hip or knee arthroplasty procedures. Patients were treated with early mobilisation, calf compression device and 300 mg aspirin for 5 days and then 100 mg aspirin for 5 weeks. All patients received lower-limb duplex ultrasonography prior to discharge. Patients were clinically evaluated at 6 weeks post-op documenting any VTE. RESULTS 51 TJA's (12.87%) were complicated by VTE: one proximal, 47 distal DVT and 3 PE. No fatal PE occurred. Only four DVT were symptomatic. Of 159 THA, 2 (1.25%) had VTE: one distal DVT and one PE. Of 237 TKA, 49 (20.67%) had VTE: 1 proximal, 46 distal DVT and 2 PE. Patients with a history of diabetes and those receiving TKA were at higher risk of DVT. CONCLUSION Multimodal VTE prophylaxis demonstrated a low rate of proximal DVT, PE and bleeding complications. The rate of asymptomatic DVT was high, but most were distal and unlikely to be clinically significant. Patients with diabetes and those receiving TKA could be at higher risk of asymptomatic DVT, and may benefit from closer clinical assessment. These findings suggest aspirin is safe and efficacious when used in combination with mechanical compressors and early mobilisation. However, our findings require further validation, particularly with larger, prospective comparative studies.
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Affiliation(s)
- Vincent V. G An
- Faculty of Medicine, University of Sydney, Camperdown, Australia,Corresponding author. 93 Arthur Street, Strathfield, NSW, 2135, Australia.
| | - Yadin D. Levy
- Sydney Olympic Park Hip and Knee Clinic, Sydney Olympic Park, Australia
| | - Peter M. Walker
- Sydney Olympic Park Hip and Knee Clinic, Sydney Olympic Park, Australia,Department of Orthopaedics, Concord Repatriation General Hospital, Concord, Australia
| | - Warwick J.M. Bruce
- Faculty of Medicine, University of Sydney, Camperdown, Australia,Sydney Olympic Park Hip and Knee Clinic, Sydney Olympic Park, Australia,Department of Orthopaedics, Concord Repatriation General Hospital, Concord, Australia
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Matharu GS, Kunutsor SK, Judge A, Blom AW, Whitehouse MR. Clinical Effectiveness and Safety of Aspirin for Venous Thromboembolism Prophylaxis After Total Hip and Knee Replacement: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Intern Med 2020; 180:376-384. [PMID: 32011647 PMCID: PMC7042877 DOI: 10.1001/jamainternmed.2019.6108] [Citation(s) in RCA: 169] [Impact Index Per Article: 33.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/14/2022]
Abstract
IMPORTANCE Patients undergoing total hip replacement (THR) and total knee replacement (TKR) receive venous thromboembolism (VTE) pharmacoprophylaxis. It is unclear which anticoagulant is preferable. Observational data suggest aspirin provides effective VTE prophylaxis. OBJECTIVE To assess the effectiveness and safety of aspirin for VTE prophylaxis after THR and TKR. DATA SOURCES A systematic review and meta-analysis was performed of randomized clinical trials (RCTs), with no language restrictions, from inception to September 19, 2019, using MEDLINE, Embase, Web of Science, Cochrane Library, and bibliographic searches. The computer-based searches combined terms and combinations of keywords related to the population (eg, hip replacement, knee replacement, hip arthroplasty, and knee arthroplasty), drug intervention (eg, aspirin, heparin, clexane, dabigatran, rivaroxaban, and warfarin), and outcome (eg, venous thromboembolism, deep vein thrombosis, pulmonary embolism, and bleeding) in humans. STUDY SELECTION This study included RCTs assessing the effectiveness and safety of aspirin for VTE prophylaxis compared with other anticoagulants in adults undergoing THR and TKR. The RCTs with a placebo control group were excluded. The searches and study selection were independently performed. DATA EXTRACTION AND SYNTHESIS This study followed PRISMA recommendations and used the Cochrane Collaboration's risk of bias tool. Data were screened and extracted independently by both reviewers. Study-specific relative risks (RRs) were aggregated using random-effects models. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. MAIN OUTCOMES AND MEASURES The primary outcome was any postoperative VTE (asymptomatic or symptomatic). Secondary outcomes were adverse events associated with therapy, including bleeding. RESULTS Of 437 identified articles, 13 RCTs were included (6060 participants; 3466 [57.2%] women; mean age, 63.0 years). The RR of VTE after THR and TKR was 1.12 (95% CI, 0.78-1.62) for aspirin compared with other anticoagulants. Comparable findings were observed for deep vein thrombosis (DVT) (RR, 1.04; 95% CI, 0.72-1.51) and pulmonary embolism (PE) (RR, 1.01; 95% CI, 0.68-1.48). The risk of adverse events, including major bleeding, wound hematoma, and wound infection, was not statistically significantly different in patients receiving aspirin vs other anticoagulants. When analyzing THRs and TKRs separately, there was no statistically significant difference in the risk of VTE, DVT, and PE between aspirin and other anticoagulants. Aspirin had a VTE risk not statistically significantly different from low-molecular-weight heparin (RR, 0.76; 95% CI, 0.37-1.56) or rivaroxaban (RR, 1.52; 95% CI, 0.56-4.12). The quality of the evidence ranged from low to high. CONCLUSIONS AND RELEVANCE In terms of clinical effectiveness and safety profile, aspirin did not differ statistically significantly from other anticoagulants used for VTE prophylaxis after THR and TKR. Future trials should focus on noninferiority analysis of aspirin compared with alternative anticoagulants and cost-effectiveness.
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Affiliation(s)
- Gulraj S Matharu
- Musculoskeletal Research Unit, Bristol Medical School, Southmead Hospital, University of Bristol, Bristol, United Kingdom
| | - Setor K Kunutsor
- Musculoskeletal Research Unit, Bristol Medical School, Southmead Hospital, University of Bristol, Bristol, United Kingdom.,National Institute for Health Research Bristol Biomedical Research Centre, Bristol, United Kingdom
| | - Andrew Judge
- Musculoskeletal Research Unit, Bristol Medical School, Southmead Hospital, University of Bristol, Bristol, United Kingdom.,National Institute for Health Research Bristol Biomedical Research Centre, Bristol, United Kingdom
| | - Ashley W Blom
- Musculoskeletal Research Unit, Bristol Medical School, Southmead Hospital, University of Bristol, Bristol, United Kingdom.,National Institute for Health Research Bristol Biomedical Research Centre, Bristol, United Kingdom
| | - Michael R Whitehouse
- Musculoskeletal Research Unit, Bristol Medical School, Southmead Hospital, University of Bristol, Bristol, United Kingdom.,National Institute for Health Research Bristol Biomedical Research Centre, Bristol, United Kingdom
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38
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Anderson DR, Morgano GP, Bennett C, Dentali F, Francis CW, Garcia DA, Kahn SR, Rahman M, Rajasekhar A, Rogers FB, Smythe MA, Tikkinen KAO, Yates AJ, Baldeh T, Balduzzi S, Brożek JL, Ikobaltzeta IE, Johal H, Neumann I, Wiercioch W, Yepes-Nuñez JJ, Schünemann HJ, Dahm P. American Society of Hematology 2019 guidelines for management of venous thromboembolism: prevention of venous thromboembolism in surgical hospitalized patients. Blood Adv 2019; 3:3898-3944. [PMID: 31794602 PMCID: PMC6963238 DOI: 10.1182/bloodadvances.2019000975] [Citation(s) in RCA: 353] [Impact Index Per Article: 58.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2019] [Accepted: 10/22/2019] [Indexed: 12/16/2022] Open
Abstract
BACKGROUND Venous thromboembolism (VTE) is a common source of perioperative morbidity and mortality. OBJECTIVE These evidence-based guidelines from the American Society of Hematology (ASH) intend to support decision making about preventing VTE in patients undergoing surgery. METHODS ASH formed a multidisciplinary guideline panel balanced to minimize bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline-development process, including performing systematic reviews. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment. RESULTS The panel agreed on 30 recommendations, including for major surgery in general (n = 8), orthopedic surgery (n = 7), major general surgery (n = 3), major neurosurgical procedures (n = 2), urological surgery (n = 4), cardiac surgery and major vascular surgery (n = 2), major trauma (n = 2), and major gynecological surgery (n = 2). CONCLUSIONS For patients undergoing major surgery in general, the panel made conditional recommendations for mechanical prophylaxis over no prophylaxis, for pneumatic compression prophylaxis over graduated compression stockings, and against inferior vena cava filters. In patients undergoing total hip or total knee arthroplasty, conditional recommendations included using either aspirin or anticoagulants, as well as for a direct oral anticoagulant over low-molecular-weight heparin (LMWH). For major general surgery, the panel suggested pharmacological prophylaxis over no prophylaxis, using LMWH or unfractionated heparin. For major neurosurgery, transurethral resection of the prostate, or radical prostatectomy, the panel suggested against pharmacological prophylaxis. For major trauma surgery or major gynecological surgery, the panel suggested pharmacological prophylaxis over no prophylaxis.
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Affiliation(s)
- David R Anderson
- Department of Medicine, Dalhousie University, Halifax, NS, Canada
| | - Gian Paolo Morgano
- Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada
| | | | - Francesco Dentali
- Department of Medicine and Surgery, Insubria University, Varese, Italy
| | - Charles W Francis
- Wilmot Cancer Center, University of Rochester Medical Center, Rochester, NY
| | - David A Garcia
- Division of Hematology, Department of Medicine, University of Washington Medical Center, University of Washington School of Medicine, Seattle, WA
| | - Susan R Kahn
- Department of Medicine, McGill University and Lady Davis Institute, Montreal, QC, Canada
| | | | - Anita Rajasekhar
- Division of Hematology and Oncology, Department of Medicine, University of Florida, Gainesville, FL
| | - Frederick B Rogers
- Trauma and Acute Care Surgery, Penn Medicine Lancaster General Health, Lancaster, PA
| | - Maureen A Smythe
- Department of Pharmaceutical Services, Beaumont Hospital, Royal Oak, MI
- Department of Pharmacy Practice, Wayne State University, Detroit, MI
| | - Kari A O Tikkinen
- Department of Urology and
- Department of Public Health, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | - Adolph J Yates
- Department of Orthopedic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA
| | - Tejan Baldeh
- Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada
| | - Sara Balduzzi
- Department of Diagnostic, Clinical, and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy
| | - Jan L Brożek
- Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada
- Department of Medicine and
| | | | - Herman Johal
- Center for Evidence-Based Orthopaedics, Division of Orthopaedic Surgery, McMaster University, Hamilton, ON, Canada
| | - Ignacio Neumann
- Department of Internal Medicine, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile
| | - Wojtek Wiercioch
- Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada
| | | | - Holger J Schünemann
- Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada
- Department of Medicine and
| | - Philipp Dahm
- Urology Section, Minneapolis VA Health Care System, Minneapolis, MN; and
- Department of Urology, University of Minnesota, Minneapolis, MN
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Nadi S, Vreugdenburg TD, Atukorale Y, Ma N, Maddern G, Rovers M. Safety and effectiveness of aspirin and enoxaparin for venous thromboembolism prophylaxis after total hip and knee arthroplasty: a systematic review. ANZ J Surg 2019; 89:1204-1210. [PMID: 30989803 DOI: 10.1111/ans.15122] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/12/2018] [Revised: 01/22/2019] [Accepted: 01/30/2019] [Indexed: 11/30/2022]
Abstract
BACKGROUND Patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA) are at risk of venous thromboembolism (VTE). Australian orthopaedic guidelines recommend aspirin and low-molecular-weight heparin (e.g. enoxaparin) for VTE prophylaxis; however, there is debate in the international literature around the use of aspirin as VTE prophylaxis. This review assesses the risks and benefits of aspirin compared to enoxaparin as VTE prophylaxis for patients undergoing THA or TKA. METHODS A systematic review was conducted to identify relevant randomized controlled trials. Studies comparing enoxaparin, aspirin and/or placebo for VTE prophylaxis in THA or TKA patients were included. Network meta-analysis (NMA) was performed to calculate risk ratios (RRs) and confidence intervals (CIs). Quality appraisal was conducted by assessing risk of bias and the strength of the evidence. RESULTS Nine randomized controlled trials were eligible for inclusion. The NMA found no statistically significant differences for the investigated outcomes: total DVT rates (RR = 1.21, 95% CI 0.86, 1.72), symptomatic pulmonary embolism (PE) rates (RR = 1.02, 95% CI 0.02, 50.86), major haemorrhage (RR = 0.97, 95% CI 0.02, 50.99) and wound complication (RR = 0.73, 95% CI 0.17, 3.20). The occurrence of PE was rare. Due to limited data, sub-group analysis was not possible. The overall quality of evidence in the NMA is considered to be very low. CONCLUSION This review did not find statistically significant differences between aspirin and enoxaparin. Future studies should identify more evidence, particularly for rare outcomes such as PE, as this might help decision-makers to get consensus on the use of aspirin as VTE prophylaxis.
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Affiliation(s)
- Sinan Nadi
- Research and Evaluation, Incorporating ASERNIP-S, Royal Australasian College of Surgeons, Adelaide, South Australia, Australia.,Department of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
| | - Thomas D Vreugdenburg
- Research and Evaluation, Incorporating ASERNIP-S, Royal Australasian College of Surgeons, Adelaide, South Australia, Australia
| | - Yasoba Atukorale
- Research and Evaluation, Incorporating ASERNIP-S, Royal Australasian College of Surgeons, Adelaide, South Australia, Australia
| | - Ning Ma
- Research and Evaluation, Incorporating ASERNIP-S, Royal Australasian College of Surgeons, Adelaide, South Australia, Australia
| | - Guy Maddern
- Research and Evaluation, Incorporating ASERNIP-S, Royal Australasian College of Surgeons, Adelaide, South Australia, Australia.,Discipline of Surgery, The University of Adelaide and The Queen Elizabeth Hospital, Adelaide, South Australia, Australia
| | - Maroeska Rovers
- Department of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
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Woon CYL, Shah RR, Pardi BM, Schwartz BE, Goldstein JM, Cipparrone NE, Goldstein WM. Aspirin Alone Is Not Enough to Prevent Deep Venous Thrombosis After Total Joint Arthroplasty. Orthopedics 2019; 42:48-55. [PMID: 30602046 DOI: 10.3928/01477447-20181227-02] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/05/2018] [Accepted: 12/03/2018] [Indexed: 02/03/2023]
Abstract
Thromboembolic events after total joint arthroplasty are potentially devastating complications. This study evaluated the efficacy of 4 different anticoagulants in preventing deep venous thrombosis and pulmonary embolism after total joint arthroplasty. The demographics and anticoagulant use (warfarin, enoxaparin, and aspirin with and without outpatient mechanical pumps) for patients who underwent primary unilateral total joint arthroplasties performed by a single surgeon from January 2013 to October 2014 were retrospectively reviewed. All patients underwent lower extremity ultrasound at the 3-week postoperative visit. A total of 613 primary unilateral total joint arthroplasties met the study inclusion criteria. There were 288 primary total knee arthroplasties and 325 primary total hip arthroplasties. The patients were 62.2% female, having a mean age of 67.6±10.6 years and a mean body mass index of 30.2±5.9 kg/m2. There were 119 patients in group 1 (aspirin alone), 40 patients in group 2 (aspirin plus pumps), 246 patients in group 3 (warfarin), and 208 patients in group 4 (enoxaparin). The overall 3-week symptomatic and asymptomatic deep venous thrombosis and symptomatic pulmonary embolism rates in the entire cohort were 5.7% and 0.3%, respectively. The venous thromboembolism rate was significantly affected by the anticoagulant of choice (P<.01). Compared with aspirin alone, warfarin decreased the risk of venous thromboembolism (P<.01). Increasing age led to increased risk of venous thromboembolism (P=.05). This study indicated that aspirin chemoprophylaxis alone was not as efficacious as warfarin and enoxaparin in preventing asymptomatic and symptomatic venous thromboembolism found during routine postoperative surveillance with lower extremity ultrasound. Aspirin alone may be inadequate and should be augmented with an outpatient mechanical pump as part of multimodal prophylaxis. [Orthopedics. 2019; 42(1):48-55.].
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Feng JE, Novikov D, Anoushiravani AA, Wasterlain AS, Lofton HF, Oswald W, Nazemzadeh M, Weiser S, Berger JS, Iorio R. Team Approach: Perioperative Optimization for Total Joint Arthroplasty. JBJS Rev 2018; 6:e4. [DOI: 10.2106/jbjs.rvw.17.00147] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/29/2023]
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Low-Dose Aspirin Is Safe and Effective for Venous Thromboembolism Prophylaxis Following Total Knee Arthroplasty. J Arthroplasty 2018; 33:S131-S135. [PMID: 29656974 DOI: 10.1016/j.arth.2018.03.001] [Citation(s) in RCA: 54] [Impact Index Per Article: 7.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/04/2017] [Revised: 03/02/2018] [Accepted: 03/03/2018] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Aspirin is an effective prophylaxis for venous thromboembolism (VTE) after total knee arthroplasty (TKA). The optimal prophylactic aspirin dose has not been established. The study aims to compare 2 aspirin regimens with regard to the incidence of (1) symptomatic deep venous thrombosis (DVT), (2) pulmonary embolism (PE), (3) bleeding, and (4) mortality within 90 days after TKA. METHODS We retrospectively identified 5666 patients who received aspirin twice daily for 4 to 6 weeks after TKA. A total of 1327 patients received 81-mg BID and 4339 patients received 325-mg BID aspirin. Postoperative complications collected were VTEs (DVT and PE), bleeding (gastrointestinal or wound bleeding), and mortality. RESULTS The incidence of VTE was 1.5% in the 325-mg group and 0.7% in the 81-mg group (P = .02). Symptomatic DVT was 1.4% in the 325-mg aspirin compared with 0.3% for the 81-mg aspirin (P = .0009). Regression model showed no correlation between aspirin dose and VTE incidence (odds ratio [OR] = 1.03; 95% confidence interval [95% CI], 0.45-2.36; P = .94) or DVT (OR = 0.50; 95% CI, 0.16-1.55; P = .20). The incidence of PE was 0.2% in the high-aspirin group compared with 0.4% in the low-aspirin group (P = .13). Bleeding was 0.2% in the 325-mg aspirin group and 0.2% in the 81-mg aspirin group (P = .62), and 90-day mortality was similar (0.1%) between the groups (P = .56). CONCLUSION Low-dose aspirin was not inferior to high-dose aspirin for the prevention of VTE after TKA. Low-dose aspirin can be considered a safe and effective agent in the prevention of VTE after TKA.
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Azboy I, Barrack R, Thomas AM, Haddad FS, Parvizi J. Aspirin and the prevention of venous thromboembolism following total joint arthroplasty: commonly asked questions. Bone Joint J 2017; 99-B:1420-1430. [PMID: 29092979 PMCID: PMC5742873 DOI: 10.1302/0301-620x.99b11.bjj-2017-0337.r2] [Citation(s) in RCA: 83] [Impact Index Per Article: 10.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2017] [Accepted: 07/19/2017] [Indexed: 12/17/2022]
Abstract
The number of arthroplasties being performed
increases each year. Patients undergoing an arthroplasty are at
risk of venous thromboembolism (VTE) and appropriate prophylaxis
has been recommended. However, the optimal protocol and the best
agent to minimise VTE under these circumstances are not known. Although
many agents may be used, there is a difference in their efficacy
and the risk of bleeding. Thus, the selection of a particular agent relies
on the balance between the desire to minimise VTE and the attempt
to reduce the risk of bleeding, with its undesirable, and occasionally
fatal, consequences. Acetylsalicylic acid (aspirin) is an agent for VTE prophylaxis
following arthroplasty. Many studies have shown its efficacy in
minimising VTE under these circumstances. It is inexpensive and
well-tolerated, and its use does not require routine blood tests.
It is also a ‘milder’ agent and unlikely to result in haematoma
formation, which may increase both the risk of infection and the
need for further surgery. Aspirin is also unlikely to result in persistent
wound drainage, which has been shown to be associated with the use
of agents such as low-molecular-weight heparin (LMWH) and other
more aggressive agents. The main objective of this review was to summarise the current
evidence relating to the efficacy of aspirin as a VTE prophylaxis
following arthroplasty, and to address some of the common questions
about its use. There is convincing evidence that, taking all factors into account,
aspirin is an effective, inexpensive, and safe form of VTE following
arthroplasty in patients without a major risk factor for VTE, such
as previous VTE. Cite this article: Bone Joint J 2017;99-B:1420–30.
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Affiliation(s)
- I Azboy
- Rothman Institute at Thomas Jefferson University Hospital, Sheridan Building, Suite 1000, 125 South 9th Street, Philadelphia, PA 19107, USA
| | - R Barrack
- Washington University Orthopedics, Barnes Jewish Hospital, 660 South Euclid Avenue, Campus Box 8233, St. Louis, Missouri 63110, USA
| | - A M Thomas
- The Royal Orthopaedic Hospital, Bristol Road South, Birmingham B31 2AP, UK
| | - F S Haddad
- University College London Hospitals, 235 Euston Road, London NW1 2BU, UK and NIHR University College London Hospitals Biomedical Research Centre, UK
| | - J Parvizi
- Rothman Institute at Thomas Jefferson University Hospital, Sheridan Building, Suite 1000, 125 South 9th Street, Philadelphia, PA 19107, USA
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Suen K, Westh RN, Churilov L, Hardidge AJ. Low-Molecular-Weight Heparin and the Relative Risk of Surgical Site Bleeding Complications: Results of a Systematic Review and Meta-Analysis of Randomized Controlled Trials of Venous Thromboprophylaxis in Patients After Total Joint Arthroplasty. J Arthroplasty 2017; 32:2911-2919.e6. [PMID: 28522244 DOI: 10.1016/j.arth.2017.04.010] [Citation(s) in RCA: 25] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/06/2017] [Revised: 03/12/2017] [Accepted: 04/02/2017] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Venous thromboembolism causes significant morbidity and mortality in patients after total joint arthroplasty. Although network meta-analyses have demonstrated a benefit of various thromboprophylactic agents, there remains a concern in the surgical community regarding the resulting wound complications. There is currently no systematic review of the surgical site bleeding complications of thromboprophylactic agents. The aim of this study was to systematically review the surgical site bleeding outcomes of venous thromboembolism prophylaxis in this population. METHODS A systematic review and meta-analysis was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized controlled trials comparing more than one of low-molecular-weight heparin (LMWH), warfarin, rivaroxaban, apixaban, dabigatran, aspirin, or no pharmacologic treatment in patients after total hip or knee arthroplasty were selected for inclusion. Five meta-analyses were performed to compare LMWH with control, warfarin, apixaban, rivaroxaban, and dabigatran. RESULTS Forty-five randomized controlled trials of 56,730 patients were included. LMWH had a significantly increased relative risk of surgical site bleeding in comparison with control (relative risk, 2.32; 95% confidence interval, 1.40-3.85) and warfarin (1.54; 1.23-1.94). The relative risk of LMWH trended higher than apixaban (1.27; 1.00-1.63) and was similar to rivaroxaban (0.95; 0.74-1.23). Only 1 study reported the risk of surgical site bleeding in LMWH vs dabigatran (5.97; 2.08-17.11). CONCLUSION LMWH increased the risk of surgical site bleeding compared with control, warfarin. and dabigatran and trended toward an increased risk compared with apixaban. The risk of surgical site bleeding was similar with LMWH and rivaroxaban.
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Affiliation(s)
- Kary Suen
- Department of Orthopaedic Surgery, Austin Health, Heidelberg, Victoria, Australia
| | - Roger N Westh
- Department of Orthopaedic Surgery, Austin Health, Heidelberg, Victoria, Australia
| | - Leonid Churilov
- Department of Statistics and Decision Support, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia
| | - Andrew J Hardidge
- Department of Orthopaedic Surgery, Austin Health, Heidelberg, Victoria, Australia; Department of Statistics and Decision Support, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia
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Parvizi J, Ceylan HH, Kucukdurmaz F, Merli G, Tuncay I, Beverland D. Venous Thromboembolism Following Hip and Knee Arthroplasty: The Role of Aspirin. J Bone Joint Surg Am 2017; 99:961-972. [PMID: 28590382 DOI: 10.2106/jbjs.16.01253] [Citation(s) in RCA: 43] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Affiliation(s)
- Javad Parvizi
- 1The Rothman Institute at Thomas Jefferson University, Philadelphia, Pennsylvania 2Bezmialem Vakif University, Istanbul, Turkey 3Thomas Jefferson University, Philadelphia, Pennsylvania 4Musgrave Park Hospital, Belfast, United Kingdom
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Schmidt-Braekling T, Pearle AD, Mayman DJ, Westrich GH, Waldstein W, Boettner F. Deep Venous Thrombosis Prophylaxis After Unicompartmental Knee Arthroplasty: A Prospective Study on the Safety of Aspirin. J Arthroplasty 2017; 32:965-967. [PMID: 27789095 DOI: 10.1016/j.arth.2016.09.018] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/14/2016] [Revised: 09/06/2016] [Accepted: 09/21/2016] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Although venous thromboembolism is one of the leading causes of morbidity after knee arthroplasty, little data exist on the risk of deep venous thrombosis (DVT) after unicompartmental knee arthroplasty (UKA). METHODS We prospectively enrolled 112 patients undergoing UKA to determine the incidence of DVT utilizing aspirin 325 mg twice a day (BID) for 4 weeks postoperatively as DVT prophylaxis. The data were compared with a recent randomized controlled trial of patients undergoing total knee arthroplasty utilizing aspirin and Lovenox in conjunction with pneumatic compression devices. RESULTS One patient (0.9%) had an asymptomatic DVT, and none developed clinical symptoms of either DVT or pulmonary embolus. The incidence of asymptomatic and symptomatic DVT was 0.9% and 0%, respectively. CONCLUSION Our data suggest that 325 mg of aspirin BID for 4 weeks results in a very low risk of DVT for patients undergoing UKA.
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Affiliation(s)
- Tom Schmidt-Braekling
- Adult Reconstruction and Joint Replacement Division, Hospital for Special Surgery, Weill Medical College of Cornell University, New York, New York; Department of Orthopedics and Tumor Orthopedics, University of Muenster, Muenster, Germany
| | - Andrew D Pearle
- Adult Reconstruction and Joint Replacement Division, Hospital for Special Surgery, Weill Medical College of Cornell University, New York, New York
| | - David J Mayman
- Adult Reconstruction and Joint Replacement Division, Hospital for Special Surgery, Weill Medical College of Cornell University, New York, New York
| | - Geoffrey H Westrich
- Adult Reconstruction and Joint Replacement Division, Hospital for Special Surgery, Weill Medical College of Cornell University, New York, New York
| | - Wenzel Waldstein
- Adult Reconstruction and Joint Replacement Division, Hospital for Special Surgery, Weill Medical College of Cornell University, New York, New York; Department of Orthopaedics, Vienna General Hospital, Medical University of Vienna, Vienna, Austria
| | - Friedrich Boettner
- Adult Reconstruction and Joint Replacement Division, Hospital for Special Surgery, Weill Medical College of Cornell University, New York, New York
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An VVG, Phan K, Levy YD, Bruce WJM. Aspirin as Thromboprophylaxis in Hip and Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty 2016; 31:2608-2616. [PMID: 27178011 DOI: 10.1016/j.arth.2016.04.004] [Citation(s) in RCA: 89] [Impact Index Per Article: 9.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/17/2015] [Revised: 03/25/2016] [Accepted: 04/05/2016] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Venous thromboembolism (VTE) comprises pulmonary embolism and deep vein thrombosis and is a complication of particular concern in lower limb arthroplasty. In recent years, aspirin has emerged as a potential alternative thromboprophylactic agent, particularly after its acceptance as a recommended agent by the American College of Chest Physicians. Aspirin is favorable due to its relative cost-effectiveness and convenience compared to novel oral anticoagulants and warfarin. However, its efficacy since its inclusion in the American College of Chest Physicians guidelines remains unclear. The present systematic review aimed to establish the efficacy of aspirin in preventing VTE in total hip and knee arthroplasty. METHODS Electronic searches were performed using 6 databases from up to June 2015, identifying all relevant studies. Data were extracted and meta-analyzed. RESULTS Eleven relevant studies were identified for inclusion in the present meta-analysis. The overall rate of deep vein thrombosis and pulmonary embolism in both hip and knee arthroplasty was 1.2% and 0.6%, respectively. The rate of major bleeding was 0.3%. Pooled mortality rate was 0.2%. All findings demonstrated a high and significant degree of heterogeneity. CONCLUSION Aspirin, both alone and in multimodal approaches to thromboprophylaxis, confers a low rate of VTE, with a low risk of major bleeding complications. However, the evidence for its use is limited by the low quality of studies and variation in dose in dosing regimes. Future randomized controlled trials should investigate the efficacy of aspirin, as well as the ideal dosing protocol for its use in thromboprophylaxis in arthroplasty.
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Affiliation(s)
- Vincent V G An
- Faculty of Medicine, Sydney Medical School, University of Sydney, New South Wales, Australia
| | - Kevin Phan
- Faculty of Medicine, Sydney Medical School, University of Sydney, New South Wales, Australia
| | - Yadin D Levy
- Department of Orthopaedic Surgery, Concord Repatriation General Hospital, New South Wales, Australia
| | - Warwick J M Bruce
- Faculty of Medicine, Sydney Medical School, University of Sydney, New South Wales, Australia; Department of Orthopaedic Surgery, Concord Repatriation General Hospital, New South Wales, Australia
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Kakkos SK, Caprini JA, Geroulakos G, Nicolaides AN, Stansby G, Reddy DJ, Ntouvas I, Cochrane Vascular Group. Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism. Cochrane Database Syst Rev 2016; 9:CD005258. [PMID: 27600864 PMCID: PMC6457599 DOI: 10.1002/14651858.cd005258.pub3] [Citation(s) in RCA: 51] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/19/2023]
Abstract
BACKGROUND It is generally assumed by practitioners and guideline authors that combined modalities (methods of treatment) are more effective than single modalities in preventing venous thromboembolism (VTE), defined as deep vein thrombosis (DVT) or pulmonary embolism (PE), or both. This is an update of the review first published in 2008. OBJECTIVES The aim of this review was to assess the efficacy of combined intermittent pneumatic leg compression (IPC) and pharmacological prophylaxis versus single modalities in preventing venous thromboembolism. SEARCH METHODS For this update the Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (May 2016). In addition the CIS searched the Cochrane Register of Studies (CENTRAL (2016, Issue 4)). Clinical trials databases were searched for details of ongoing or unpublished studies. SELECTION CRITERIA Randomized controlled trials (RCTs) or controlled clinical trials (CCTs) of combined IPC and pharmacological interventions used to prevent VTE. DATA COLLECTION AND ANALYSIS We independently selected trials and extracted data. Disagreements were resolved by discussion. We performed fixed-effect model meta-analyses with odds ratios (ORs) and 95% confidence intervals (CIs). We used a random-effects model when there was heterogeneity. MAIN RESULTS We included a total of 22 trials (9137 participants) of which 15 were randomized trials (7762 participants). The overall risk of bias was mostly unclear or high due to selection and performance bias. We used GRADE to assess the quality of the evidence and this was downgraded from high to moderate or very low due to the risk of bias, imprecision or indirectness.The rate of PE in the studies comparing IPC alone with combined IPC and pharmacological prophylaxis was low, underpowering the analyses. The incidence of symptomatic PE was 0.79% with IPC, but ranged between 0.1 to 1% with combined IPC and pharmacological prophylaxis (OR 0.49, 95% CI 0.18 to 1.34; 12 studies, 3017 participants, moderate quality evidence). The incidence of DVT was 4.10% in the IPC group and 2.19% in the combined group showing a reduced incidence of DVT in favour of the combined group (OR 0.52, 95% CI 0.33 to 0.82; 11 studies, 2934 participants, moderate quality evidence). The addition of an anticoagulant to IPC, however, increased the risk of any bleeding compared to IPC alone; 0.66% (7/1053) in the IPC group and 4.0% (44/1102) in the combined group (OR 5.04, 95% CI 2.36 to 10.77; 7 studies, 2155 participants, moderate quality evidence). Major bleeding followed a similar pattern; 0.1% (1/1053) in the IPC group to 1.5% (17/1102) in the combined group (OR 6.81, 95% CI 1.99 to 23.28; 7 studies, 2155 participants, moderate quality evidence).We detected no difference between the type of surgery subgroups such as orthopedic and non-orthopedic participants for DVT incidence (P = 0.16). Tests for differences between type of surgery subgroups were not possible for PE incidence.Compared with pharmacological prophylaxis alone, the use of combined IPC and pharmacological prophylaxis modalities reduced the incidence of symptomatic PE from 2.92% to 1.20% (OR 0.39, 95% CI 0.23 to 0.64; 10 studies, 3544 participants, moderate quality evidence). The incidence of DVT was 6.2% in the pharmacological prophylaxis group and 2.9% in the combined group showing no difference between the combined and pharmacological prophylaxis groups (OR 0.42, 95% CI 0.18 to 1.03; 11 studies, 2866 participants, moderate quality evidence). Increased bleeding side effects were not observed for IPC when it was added to anticoagulation (bleeding: OR 0.80, 95% CI 0.30 to 2.14, very low quality evidence; major bleeding: OR 1.21, 95% CI 0.35 to 4.18, very low quality evidence, 3 studies, 244 participants).No difference was detected between the type of surgery subgroups for PE incidence (P = 0.68) or for DVT incidence (P = 0.10). AUTHORS' CONCLUSIONS Moderate quality evidence suggests that combining IPC and pharmacological prophylaxis, compared with IPC or pharmacological prophylaxis alone, decreases the incidence of DVT when compared to compression, and incidence of PE when compared to anticoagulation. Moderate quality evidence suggests that there is no difference between combined and single modalities in the incidence of PE when compared with compression alone and DVT when compared with anticoagulation alone. The quality of evidence for PE or DVT was downgraded to moderate due to imprecision or risk of bias in study methodology, highlighting the need for further research. Moderate quality evidence suggests the addition of pharmacological prophylaxis to IPC, increased the risk of bleeding compared to IPC alone, a side effect not observed for IPC when added to pharmacological prophylaxis (very low quality evidence), as expected for a physical method of thromboprophylaxis. The quality of evidence for bleeding was downgraded to moderate due to indirectness or very low due to risk of bias in study methodology, indirectness and imprecision highlighting the need for further research. Nevertheless, the results of the current review agree with current guideline recommendations, which support the use of combined modalities in hospitalised patients (limited to those with trauma or undergoing surgery) at risk of developing VTE. More studies on the role of combined modalities in VTE prevention are needed.
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Affiliation(s)
- Stavros K Kakkos
- University of Patras Medical SchoolDepartment of Vascular SurgeryHippocrates Ave, RioPatrasAchaiaGreece26504
| | - Joseph A Caprini
- Evanston Northwestern HealthcareDepartment of SurgeryNorthwestern UniversityEvanstonIllinoisUSA60201
| | - George Geroulakos
- Ealing Hospital and Imperial College, LondonVascular Unit and Department of Vascular SurgeryUxbridge RoadSouthallMiddlesexUKUB1 3HW
| | - Andrew N Nicolaides
- Vascular Screening and Diagnostic Centre, Cyprus University2 Kyriacou Matsi StreetAyios DhometiosNicosiaCyprus2368
| | - Gerard Stansby
- Freeman HospitalNorthern Vascular CentreNewcastle upon TyneUKNE7 7DN
| | - Daniel J Reddy
- Department of SurgeryDivision of Vascular SurgeryHenry Ford Hospital2799 W. Grand BoulevardDetroitMichiganUSA28202
| | - Ioannis Ntouvas
- University Hospital of PatrasVascular SurgeryPatrasGreece26504
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