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Suriano M, Ritonga ITP, Donas KP, Austermann MJ, Usai MV. Drug Eluting Stents Below the Knee: Patency, Amputation-Rate, and Mortality-A Systematic Review of the Literature. J Endovasc Ther 2025:15266028251324809. [PMID: 40110974 DOI: 10.1177/15266028251324809] [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: 03/22/2025]
Abstract
BACKGROUND Numerous meta-analyses and multicenter randomized controlled trials have demonstrated that drug-eluting stents (DES) offer superior outcomes in terms of primary patency and limb salvage compared to other endovascular modalities such as balloon angioplasty and bare metal stents. This review aims to systematically analyze the literature on the clinical outcomes of DES for the treatment of infrapopliteal arterial occlusions. METHODS This study is a systematic review. Comprehensive searches were conducted in the MEDLINE, EMBASE, Ovid, Cochrane, DAR, and BVS databases. Eligible studies were those that reported outcomes of DES in the treatment of infrapopliteal arterial disease, with no restrictions on time frame, publication status, or language. The primary outcome assessed was the primary patency of the stent, while secondary outcomes included the rates of re-occlusion and mortality. RESULTS A total of 27 studies involving 2470 patients were included in the analysis, in which 1191 patients come from prospective multicenter studies. The mean age of the participants was 73.4 years. Approximately, 50% of the patients had diabetes mellitus and/or chronic renal failure, and 33.3% had heart disease. The fibular artery was the most frequently affected by stenosis, involved in 50.2% of cases, followed by the anterior tibial artery in 34.6% of cases and the posterior tibial artery in 15.2% of cases. The average patency rate following DES treatment was 72.2% at 12 months. The rate of re-occlusion was 21.6%, and the mortality rate was 16.6%. However, due to the heterogeneity of the sample and incomplete data, it was not possible to draw definitive correlations between patency, amputation rates, and mortality. CONCLUSION This systematic review and analysis revealed significant limitations due to the heterogeneity of the sample and incomplete data, preventing a comprehensive stratification of the findings. As a result, we are not yet able to fully address the research questions posed. Further studies with extended follow-up periods are needed to standardize the treatment of infrapopliteal arterial occlusions and provide more definitive conclusions.Clinical ImpactThis review assessed the efficacy and safety of drug-eluting stents for below-the-knee lesions, showing promising patency and safety results. Their use in daily practice may aid in treating lesions prone to recoil and dissection after angioplasty. Despite some data inconsistencies, the findings remain encouraging. Drug-eluting stents demonstrated better outcomes than Bare-metal Stent, supporting their consideration in clinical practice for below-the-knee vascular treatment.
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Affiliation(s)
- Marco Suriano
- Department of Vascular Surgery, St. Franziskus Hospital, Münster, Germany
| | - Imam T P Ritonga
- Department of Vascular Surgery, St. Franziskus Hospital, Münster, Germany
| | - Konstantinos P Donas
- Department of Vascular Surgery, Rhein Main Vascular Center, Asklepios Clinics Langen, Wiesbaden, Seligenstadt, Germany
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Li MX, Tu HX, Yin MC. Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries. World J Clin Cases 2023; 11:5273-5287. [PMID: 37621588 PMCID: PMC10445070 DOI: 10.12998/wjcc.v11.i22.5273] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Revised: 07/07/2023] [Accepted: 07/17/2023] [Indexed: 08/04/2023] Open
Abstract
BACKGROUND Percutaneous drug-eluting stent implantation (DESI) is an emerging and promising treatment modality for infrapopliteal artery diseases (IPADs). This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio (HR), which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio. AIM To explore the superiority of drug-eluting stents (DESs) vs traditional treatment modalities for IPADs. METHODS The following postoperative indicators were the outcomes of interest: All-cause death (ACD)-free survival, major amputation (MA)-free survival, target lesion revascularization (TLR)-free survival, adverse event (AE)-free survival, and primary patency (PP) survival. The outcome measures were then compared according to their respective HRs with 95% confidence intervals (CIs). The participants were human IPAD patients who underwent treatments for infrapopliteal lesions. DESI was set as the intervention arm, and traditional percutaneous transluminal angioplasty (PTA) with or without bare metal stent implantation (BMSI) was set as the control arm. A systematic search in the Excerpta Medica Database (Embase), PubMed, Web of Science, and Cochrane Library was performed on November 29, 2022. All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included. When studies did not directly report the HRs but gave a corresponding survival curve, we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs. Then, meta-analyses were conducted using a random-effects model. RESULTS Five randomized controlled trials and three cohort studies involving 2639 participants were included. The ACD-free and MA-free survival HR values for DESI were not statistically significant from those of the control treatment (P > 0.05); however, the HR values for TLR-free, AE-free, and PP-survival differed significantly [2.65 (95%CI: 1.56-4.50), 1.57 (95%CI: 1.23-2.01), and 5.67 (95%CI: 3.56-9.03), respectively]. CONCLUSION Compared with traditional treatment modalities (i.e., PTA with or without BMSI), DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.
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Affiliation(s)
- Ming-Xuan Li
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Hai-Xia Tu
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Meng-Chen Yin
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
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Li MX, Tu HX, Yin MC. Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries. World J Clin Cases 2023; 11:5267-5281. [DOI: 10.12998/wjcc.v11.i22.5267] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Revised: 07/07/2023] [Accepted: 07/17/2023] [Indexed: 08/03/2023] Open
Abstract
BACKGROUND Percutaneous drug-eluting stent implantation (DESI) is an emerging and promising treatment modality for infrapopliteal artery diseases (IPADs). This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio (HR), which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio.
AIM To explore the superiority of drug-eluting stents (DESs) vs traditional treatment modalities for IPADs.
METHODS The following postoperative indicators were the outcomes of interest: All-cause death (ACD)-free survival, major amputation (MA)-free survival, target lesion revascularization (TLR)-free survival, adverse event (AE)-free survival, and primary patency (PP) survival. The outcome measures were then compared according to their respective HRs with 95% confidence intervals (CIs). The participants were human IPAD patients who underwent treatments for infrapopliteal lesions. DESI was set as the intervention arm, and traditional percutaneous transluminal angioplasty (PTA) with or without bare metal stent implantation (BMSI) was set as the control arm. A systematic search in the Excerpta Medica Database (Embase), PubMed, Web of Science, and Cochrane Library was performed on November 29, 2022. All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included. When studies did not directly report the HRs but gave a corresponding survival curve, we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs. Then, meta-analyses were conducted using a random-effects model.
RESULTS Five randomized controlled trials and three cohort studies involving 2639 participants were included. The ACD-free and MA-free survival HR values for DESI were not statistically significant from those of the control treatment (P > 0.05); however, the HR values for TLR-free, AE-free, and PP-survival differed significantly [2.65 (95%CI: 1.56-4.50), 1.57 (95%CI: 1.23-2.01), and 5.67 (95%CI: 3.56-9.03), respectively].
CONCLUSION Compared with traditional treatment modalities (i.e., PTA with or without BMSI), DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.
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Affiliation(s)
- Ming-Xuan Li
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Hai-Xia Tu
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Meng-Chen Yin
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
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Fong KY, Xin L, Ng J, Loh SEK, Ng JJ, Choong AMTL. A systematic review and meta-analysis of sirolimus-eluting stents for treatment of below-the-knee arterial disease. J Vasc Surg 2023; 77:1264-1273.e3. [PMID: 36183989 DOI: 10.1016/j.jvs.2022.09.022] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/25/2022] [Revised: 08/29/2022] [Accepted: 09/19/2022] [Indexed: 10/14/2022]
Abstract
OBJECTIVE We performed a systematic review and meta-analysis to analyze the efficacy and safety of sirolimus-eluting stents (SESs) in the treatment of below-the-knee (BTK) arterial disease. METHODS An electronic literature search was conducted from inception to July 24, 2021. Retrospective, prospective, and randomized studies that had used SESs to treat BTK arterial disease and had reported the primary patency, technical success, target lesion revascularization, and/or mortality were included. Meta-analyses of the proportions were conducted to derive pooled summary statistics of the outcomes. Where Kaplan-Meier curves were provided for primary patency, a meta-analysis of the individual patient data was conducted via a graphic reconstruction tool to estimate primary patency at various follow-up points. For studies comparing SESs and bare metal stents (BMSs), a two-stage meta-analysis was performed to compare the 6-month primary patency of SESs vs BMSs. RESULTS Ten studies across 13 publications, including 995 patients, were retrieved for analysis. In the meta-analysis of proportions, across six studies (n = 339 patients), the pooled 6-month primary patency was 87.3% (95% confidence interval [CI], 81.6%-92.1%). Across seven studies (n = 283 patients), the pooled 6-month mortality was 5.4% (95% CI, 1.4%-11.2%). An individual patient data analysis of three studies (n = 282 patients) yielded a primary patency rate of 95.2% (95% CI, 92.7%-97.8%), 82.8% (95% CI, 78.3%-87.6%), 79.8% (95% CI, 75.0%-85.0%), and 79.8% (95% CI, 75.0%-85.0%) at 6, 12, 18, and 24 months, respectively. The 12-month target lesion revascularization rate across four studies (n = 324 patients) was 9.6% (95% CI, 6.4%-13.4%). In the two-stage meta-analysis of 6-month primary patency across three studies (n = 168 patients), the use of SESs was significantly favored over BMSs (risk ratio, 1.28; 95% CI, 1.12-1.46; P < .001). CONCLUSIONS The overall evidence suggests that the use of SESs appears to be safe and offers favorable outcomes for BTK arterial disease compared with BMSs.
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Affiliation(s)
- Khi Yung Fong
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore; SingVaSC, Singapore Vascular Surgical Collaborative, Singapore
| | - Liu Xin
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Magdalen College, University of Oxford, Oxford, UK
| | - Josiah Ng
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore; SingVaSC, Singapore Vascular Surgical Collaborative, Singapore
| | - Stanley E K Loh
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Diagnostic Imaging, National University Health System, Singapore
| | - Jun Jie Ng
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Vascular and Endovascular Surgery, National University Heart Centre, Singapore
| | - Andrew M T L Choong
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Vascular and Endovascular Surgery, National University Heart Centre, Singapore; Cardiovascular Research Institute, National University of Singapore, Singapore.
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Violari E, Payomo A, Schiro BJ, Powell A, Gandhi RT, Pena CS. Endovascular Treatment of Infra-Inguinal Peripheral Arterial Disease (PAD): Update on Stent Technology. Tech Vasc Interv Radiol 2022; 25:100840. [PMID: 35842258 DOI: 10.1016/j.tvir.2022.100840] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
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Taeymans K, Bosiers M, Deloose K, Callaert J, Keirse K, Verbist J, van den Eynde W, Torsello G, Wauters J. One-year outcome of the everolimus-eluting, balloon-expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in CLI patients. THE JOURNAL OF CARDIOVASCULAR SURGERY 2020; 61:445-450. [DOI: 10.23736/s0021-9509.19.10830-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
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Ferrone M, Cheng Y, Granada JF. Current concepts regarding drug dosing for peripheral stents. THE JOURNAL OF CARDIOVASCULAR SURGERY 2019; 60:439-449. [PMID: 31062571 DOI: 10.23736/s0021-9509.19.10995-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Drug-eluting stent (DES) are the mainstay therapy for the treatment of coronary artery disease. Stent design and drug-elution strategies have evolved over the years leading to the last generation DES which shows optimal safety and efficacy outcome. Peripheral arteries have different mechanical and biological features and the lessons learned from the coronary field have been difficult to introduce into the development of peripheral vascular technologies. First, due to its complex biomechanical behavior the use of metallic stents is limited in some vascular segments (i.e., distal superficial fermoral artery [SFA]). Also, peripheral vascular atherosclerosis is different containing higher levels of plaque burden and calcium. Finally, peripheral arterial disease tends to be more aggressive including longer lesions and higher incidence of total chronic occlusion. In general terms, restenosis in the peripheral vascular territory is more aggressive and occurs at a later time (~12 months) requiring a different pharmacokinetic profile compared to coronary technologies. Several strategies have been evaluated in the peripheral arteries raging from the bare metal stent to the drug coated balloon and drug eluting stent with outcome varying depending on the different field of application (i.e. SFA and below-the-knee). Results coming from the clinical trial are encouraging but further studies and direct comparison among the different technologies are demanded to determine the best therapy for peripheral vascular disease.
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Affiliation(s)
- Marco Ferrone
- Cardiovascular Research Foundation, Skirball Center for Innovation, Orangeburg, NY, USA.,Federico II University of Naples, Naples, Italy
| | - Yanping Cheng
- Cardiovascular Research Foundation, Skirball Center for Innovation, Orangeburg, NY, USA
| | - Juan F Granada
- Cardiovascular Research Foundation, Skirball Center for Innovation, Orangeburg, NY, USA -
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Spiliopoulos S, Vasiniotis Kamarinos N, Brountzos E. Current evidence of drug-elution therapy for infrapopliteal arterial disease. World J Cardiol 2019; 11:13-23. [PMID: 30705739 PMCID: PMC6354073 DOI: 10.4330/wjc.v11.i1.13] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2018] [Revised: 10/23/2018] [Accepted: 01/01/2019] [Indexed: 02/06/2023] Open
Abstract
New and sophisticated endovascular devices, such as drug-eluting stents (DES) and drug-coated balloons (DCB), provide targeted drug delivery to affected vessels. The invention of these devices has made it possible to address the reparative cascade of arterial wall injury following balloon angioplasty that results in restenosis. DESs were first used for the treatment of infrapopliteal lesions almost 20 years ago. More recently, however, DCB technology is being investigated to improve outcomes of endovascular below-the-knee arterial procedures, avoiding the need for a metallic scaffold. Today, level IA evidence supports the use of infrapopliteal DES for short to medium length lesions, although robust evidence that justifies the use of DCBs in this anatomical area is missing. This review summarizes and discusses all available data on infrapopliteal drug-elution devices and highlights the most promising future perspectives.
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Affiliation(s)
- Stavros Spiliopoulos
- 2nd Radiology Department, Interventional Radiology Unit, University of Athens, Attikon University General Hospital, Athens 12461, Greece
| | - Nikiforos Vasiniotis Kamarinos
- 2nd Radiology Department, Interventional Radiology Unit, University of Athens, Attikon University General Hospital, Athens 12461, Greece
| | - Elias Brountzos
- 2nd Radiology Department, Interventional Radiology Unit, University of Athens, Attikon University General Hospital, Athens 12461, Greece
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Varcoe RL, Paravastu SC, Thomas SD, Bennett MH. The use of drug-eluting stents in infrapopliteal arteries: an updated systematic review and meta-analysis of randomized trials. INT ANGIOL 2019; 38:121-135. [PMID: 30650949 DOI: 10.23736/s0392-9590.19.04049-5] [Citation(s) in RCA: 39] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/28/2023]
Abstract
INTRODUCTION Endovascular treatment below-the-knee is safe and effective but limited by poor patency. Coronary drug-eluting stents (DES) may play a role in providing mechanical scaffolding and deliver anti-proliferative drug to the site of vascular barotrauma to reduce the incidence of restenosis. Our aim was to evaluate and compare the use of contemporary DES with standard endovascular-therapies for atherosclerotic disease of infrapopliteal arteries. EVIDENCE ACQUISITION We performed a meta-analysis of randomized controlled trials comparing DES with conventional treatment for symptomatic peripheral artery disease (search date 30 August 2017). The primary endpoint was primary patency. Secondary endpoints were freedom from target lesion revascularization (TLR), major amputation, sustained Rutherford class improvement and mortality. EVIDENCE SYNTHESIS We identified 7 trials enrolling 801 randomly assigned patients (392 DES, 409 control). At the median follow-up of 12-months DES improved rates of primary patency (OR 3.49, 95%CI 2.38-5.12, I2=0%, P<0.00001), freedom from TLR (OR 2.19, 95%CI 1.30-3.69, I2=38%, P=0.003), major amputation (OR 0.56, 95%CI 0.31-0.99, I2=0%, P=0.049), and Rutherford class improvement (OR 1.62, 95%CI 1.01-2.59, I2=65%, P=0.046), but not mortality (OR 1.05, 95%CI 0.68-1.62; I2 =0%, P=0.91) compared to control. Subgroup analysis of primary patency favoured DES coated in sirolimus analogues compared to paclitaxel (Test for subgroup differences, Chi2=6.51, df=1, P=0.01, I2=84.6%). CONCLUSIONS At midterm follow-up DES significantly improved rates of primary patency, re-intervention, Rutherford class improvement and major amputation for the treatment of atherosclerotic disease of infrapopliteal arteries compared to control therapy, with no effect on patient survival. Stents coated in sirolimus analogues were more effective than paclitaxel.
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Affiliation(s)
- Ramon L Varcoe
- Department of Surgery, Prince of Wales Hospital, Sydney, Australia - .,Faculty of Medicine, University of New South Wales, Sydney, Australia - .,The Vascular Institute, Prince of Wales, Sydney, Australia -
| | - Sharath C Paravastu
- Department of Surgery, Prince of Wales Hospital, Sydney, Australia.,Department of Vascular Surgery, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK
| | - Shannon D Thomas
- Department of Surgery, Prince of Wales Hospital, Sydney, Australia.,Faculty of Medicine, University of New South Wales, Sydney, Australia.,The Vascular Institute, Prince of Wales, Sydney, Australia
| | - Michael H Bennett
- Faculty of Medicine, University of New South Wales, Sydney, Australia.,Department of Anesthesia, Prince of Wales Hospital, Sydney, Australia
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Tokuda T, Hirano K, Sakamoto Y, Takimura H, Kobayashi N, Araki M, Yamawaki M, Ito Y. Incidence and clinical outcomes of the slow-flow phenomenon after infrapopliteal balloon angioplasty. J Vasc Surg 2016; 65:1047-1054. [PMID: 27865638 DOI: 10.1016/j.jvs.2016.08.118] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/12/2016] [Accepted: 08/12/2016] [Indexed: 11/16/2022]
Abstract
OBJECTIVE This study investigated the incidence and clinical relevance of the slow-flow phenomenon after infrapopliteal balloon angioplasty. METHODS This retrospective, single-center study included 161 consecutive patients with critical limb ischemia (173 limbs) who underwent endovascular treatment for infrapopliteal lesions between January 2012 and May 2015. The overall technical success rate was 88%. Of these lesions, 30 limbs presented with slow flow after angioplasty. RESULTS Total occlusion (90% vs 63%; P < .01) and severe calcification (43% vs 8%; P < .01) were more common in the slow-flow group. Kaplan-Meier curve analysis revealed that freedom from major amputation (60% vs 86%; log-rank, P < .01) and wound healing at 2 years (77% vs 91%; log-rank, P = .03) were significantly less common in the slow-flow group. Univariate Cox proportional hazard analysis identified Rutherford class 6 (hazard ratio [HR], 6.4; 95% confidence interval [CI], 2.8-15.8; P < .01), the slow-flow phenomenon (HR, 3.9; 95% CI, 1.6-8.9; P < .01), and hemodialysis (HR, 3.2; 95% CI, 1.2-11.1; P = .02) as independent predictors of major amputation and Rutherford class 6 (HR, 0.3; 95% CI, 0.2-0.6; P < .01), the slow-flow phenomenon (HR, 0.5; 95% CI, 0.3-0.9; P = .02), and pedal arch (HR, 1.6; 95% CI, 1.0-2.5; P = .04) as predictors of wound healing. CONCLUSIONS The slow-flow phenomenon after infrapopliteal balloon angioplasty occurred in 18.6% of limbs. This phenomenon may result in poor outcomes.
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Affiliation(s)
- Takahiro Tokuda
- Department of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, Yokohama, Kanagawa, Japan.
| | - Keisuke Hirano
- Department of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, Yokohama, Kanagawa, Japan
| | - Yasunari Sakamoto
- Department of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, Yokohama, Kanagawa, Japan
| | - Hideyuki Takimura
- Department of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, Yokohama, Kanagawa, Japan
| | - Norihiro Kobayashi
- Department of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, Yokohama, Kanagawa, Japan
| | - Motoharu Araki
- Department of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, Yokohama, Kanagawa, Japan
| | - Masahiro Yamawaki
- Department of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, Yokohama, Kanagawa, Japan
| | - Yoshiaki Ito
- Department of Cardiovascular Medicine, Saiseikai Yokohama City Eastern Hospital, Yokohama, Kanagawa, Japan
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Di Minno G, Spadarella G, Cafaro G, Petitto M, Lupoli R, Di Minno A, de Gaetano G, Tremoli E. Systematic reviews and meta-analyses for more profitable strategies in peripheral artery disease. Ann Med 2014; 46:475-89. [PMID: 25045928 PMCID: PMC4245179 DOI: 10.3109/07853890.2014.932618] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/13/2023] Open
Abstract
In the peripheral arteries, a thrombus superimposed on atherosclerosis contributes to the progression of peripheral artery disease (PAD), producing intermittent claudication (IC), ischemic necrosis, and, potentially, loss of the limb. PAD with IC is often undiagnosed and, in turn, undertreated. The low percentage of diagnosis (∼30%) in this setting of PAD is of particular concern because of the potential worsening of PAD (amputation) and the high risk of adverse vascular outcomes (vascular death, coronary artery disease, stroke). A Medline literature search of the highest-quality systematic reviews and meta-analyses of randomized controlled trials documents that, due to risk of bias, imprecision, and indirectness, the overall quality of the evidence concerning diagnostic tools and antithrombotic interventions in PAD is generally low. Areas of research emerge from the information collected. Appropriate treatments for PAD patients will only derive from ad-hoc studies. Innovative imaging techniques are needed to identify PAD subjects at the highest vascular risk. Whether IC unresponsive to physical exercise and smoking cessation identifies those with a heritable predisposition to more severe vascular events deserves to be addressed. Devising ways to improve prevention of vascular events in patients with PAD implies a co-ordinated approach in vascular medicine.
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Affiliation(s)
- Giovanni Di Minno
- Department of Clinical Mediine and Surgery, Università degli Studi di Napoli , Naples , Italy
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Razavi MK, Mustapha JA, Miller LE. Contemporary Systematic Review and Meta-Analysis of Early Outcomes with Percutaneous Treatment for Infrapopliteal Atherosclerotic Disease. J Vasc Interv Radiol 2014; 25:1489-96, 1496.e1-3. [DOI: 10.1016/j.jvir.2014.06.018] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/22/2014] [Revised: 06/23/2014] [Accepted: 06/23/2014] [Indexed: 12/01/2022] Open
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Fusaro M, Cassese S, Ndrepepa G, Tepe G, King L, Ott I, Nerad M, Schunkert H, Kastrati A. Drug-eluting stents for revascularization of infrapopliteal arteries: updated meta-analysis of randomized trials. JACC Cardiovasc Interv 2014; 6:1284-93. [PMID: 24355118 DOI: 10.1016/j.jcin.2013.08.007] [Citation(s) in RCA: 79] [Impact Index Per Article: 7.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/07/2013] [Revised: 07/30/2013] [Accepted: 08/14/2013] [Indexed: 12/17/2022]
Abstract
OBJECTIVES This study sought to undertake an updated meta-analysis of randomized trials investigating the outcomes of percutaneous revascularization with primary drug-eluting stenting in patients with atherosclerotic disease of infrapopliteal arteries. BACKGROUND In atherosclerotic disease of infrapopliteal arteries, drug-eluting stents (DESs) improve patency rates compared with plain balloon angioplasty or bare-metal stents (BMSs). However, the clinical impact of DES placement in this vascular territory still remains uncertain. METHODS We searched MEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), scientific session abstracts, and relevant Websites. The keywords used were "below the knee," "infrapopliteal artery," "angioplasty," "drug-eluting stent(s)," "bare metal stent(s)," "trial," and "randomized trial." Inclusion criteria were randomized design, intention-to-treat analysis, and a minimum of 6-month follow-up. Exclusion criteria were vessels treated other than infrapopliteal arteries; devices used other than DESs, plain balloons, or BMSs; and duplicated data. The primary endpoint was target lesion revascularization; secondary endpoints were restenosis, amputation, death, and improvement in Rutherford class. RESULTS A total of 611 patients from 5 trials were randomly assigned to DESs (n = 294) versus control therapy (plain balloon angioplasty/BMS implantation, n = 307). Overall, the median lesion length was 26.8 mm (interquartile range [IQR]: 18.2 to 30.0 mm) with a reference vessel diameter of 2.86 mm (IQR: 2.68 to 3.00 mm). At a median follow-up of 12 months (IQR: 12 to 36 months), DESs reduced the risk of target lesion revascularization (odds ratio [OR]: 0.31; 95% confidence interval [CI]: 0.18 to 0.54; p < 0.001), restenosis (OR: 0.25; 95% CI: 0.15 to 0.43; p < 0.001), and amputation (OR: 0.50; 95% CI: 0.26 to 0.97); p = 0.04) without a significant difference in terms of death (OR: 0.81; 95% CI: 0.45 to 1.49; p = 0.50) and Rutherford class improvement (OR: 1.36; 95% CI: 0.91 to 2.04; p = 0.13) versus control therapy. CONCLUSIONS In focal disease of infrapopliteal arteries, DES therapy reduces the risk of reintervention and amputation compared with plain balloon angioplasty or BMS implantation without any impact on mortality and Rutherford class at 1-year follow-up.
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Affiliation(s)
| | | | - Gjin Ndrepepa
- Deutsches Herzzentrum, Technische Universität, Munich, Germany
| | - Gunnar Tepe
- Radiologische Klinik, Diagnostische und Interventionelle Radiologie, Karls-Universität, Tübingen, Germany
| | - Lamin King
- Deutsches Herzzentrum, Technische Universität, Munich, Germany
| | - Ilka Ott
- Deutsches Herzzentrum, Technische Universität, Munich, Germany
| | - Mateja Nerad
- Klinische Abteilung für Kardiologie, Universität Graz, Graz, Austria
| | - Heribert Schunkert
- Deutsches Herzzentrum, Technische Universität, Munich, Germany; DZHK-German Centre for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany
| | - Adnan Kastrati
- Deutsches Herzzentrum, Technische Universität, Munich, Germany; DZHK-German Centre for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany
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Canaud L, Ozdemir BA, Belli AM, Loftus IM, Thompson MM, Hinchliffe RJ. Infrainguinal angioplasty with drug-eluting stents and balloons. J Vasc Surg 2014; 59:1721-36. [DOI: 10.1016/j.jvs.2014.03.235] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/27/2013] [Accepted: 03/09/2014] [Indexed: 10/25/2022]
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Schmehl J, Tepe G. Current status of bare and drug-eluting stents in infrainguinal peripheral vascular disease. Expert Rev Cardiovasc Ther 2014; 6:531-8. [DOI: 10.1586/14779072.6.4.531] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
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Bunte MC, Shishehbor MH. Treatment of infrapopliteal critical limb ischemia in 2013: the wound perfusion approach. Curr Cardiol Rep 2013; 15:363. [PMID: 23605465 DOI: 10.1007/s11886-013-0363-5] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/16/2023]
Abstract
The primary goals of treatment for critical limb ischemia (CLI) are alleviation of ischemic rest pain, healing of arterial insufficiency ulcers, and improving quality of life. These goals are directed toward preventing limb loss and CLI-related mortality. Arterial revascularization serves as the foundation of a contemporary approach to promote amputation-free survival. Mounting evidence supports a wound-directed angiosome revascularization approach, increasingly achieved with endovascular techniques. Innovations in technology and wound-perfusion strategy have advanced patient care and are accelerating the pace of CLI treatment. The evolving angiosome revascularization approach has been augmented with a multidisciplinary wound care strategy that deserves particular emphasis. These state-of-the-art advances in CLI management are reported herein with considerations for the future treatment of CLI.
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Affiliation(s)
- Matthew C Bunte
- Robert & Suzanne Tomsich Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Mail code J3-5, 9500 Euclid Avenue, Cleveland, OH 44195, USA
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18
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Antoniou GA, Chalmers N, Kanesalingham K, Antoniou SA, Schiro A, Serracino-Inglott F, Smyth JV, Murray D. Meta-analysis of outcomes of endovascular treatment of infrapopliteal occlusive disease with drug-eluting stents. J Endovasc Ther 2013; 20:131-44. [PMID: 23581752 DOI: 10.1583/1545-1550-20.2.131] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/27/2022]
Abstract
PURPOSE To review emerging evidence regarding the use of bare metal (BMS) vs. drug-eluting stents (DES) in the treatment of infrapopliteal occlusive disease. METHODS A systematic review of the literature was undertaken to identify all studies comparing stent treatments of infragenicular vessels in patients with chronic lower limb ischemia. Validated methods to assess the methodological quality of the included studies were applied. Outcome data were pooled, and combined overall effect sizes were calculated using fixed or random effects models. The search identified 4 randomized clinical trials and 2 observational studies reporting on 544 patients (287 treated with DES and 257 treated with BMS). Data are presented as the odds ratio (OR) with 95% confidence interval (CI) and the number-needed-to-treat (NNT). RESULTS Primary patency, freedom from target lesion revascularization, and clinical improvement at 1 year were significantly higher in the DES recipients compared to patients treated with BMS (OR 4.511, 95% CI 2.897 to 7.024, p<0.001, NNT 3.5; OR 3.238, 95% CI 2.019 to 5.192, p<0.001, NNT 6.0; and OR 1.792, 95% CI 1.039 to 3.090, p=0.036, NNT 7.3, respectively). No significant differences in limb salvage and overall survival at 1 year were identified between the groups (OR 2.008, 95% CI 0.722 to 5.585, p=0.181; OR 1.262, 95% CI 0.605 to 2.634, p=0.535, respectively). Sensitivity analyses investigating the potential effects of study design and type of DES on the combined outcome estimates validated the results. CONCLUSION Our analysis has demonstrated superior short-term results with DES compared with BMS, expressed by increased patency and freedom from target lesion revascularization. The influence of this finding on clinical surrogate endpoints, such as limb salvage, remains unknown.
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Affiliation(s)
- George A Antoniou
- Department of Vascular and Endovascular Surgery, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, UK.
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Baumann F, Engelberger RP, Willenberg T, Do DD, Kalka C, Baumgartner I, Diehm N. Infrapopliteal lesion morphology in patients with critical limb ischemia: implications for the development of anti-restenosis technologies. J Endovasc Ther 2013; 20:149-56. [PMID: 23581754 DOI: 10.1583/1545-1550-20.2.149] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/27/2022]
Abstract
PURPOSE To angiographically evaluate infrapopliteal arterial lesion morphology in a consecutive series of patients presenting with critical limb ischemia (CLI) and undergoing infrapopliteal angioplasty. METHODS A prospective analysis was undertaken of a consecutive series of CLI patients undergoing endovascular therapy in a tertiary referral center in the year 2011. Morphological assessment of baseline angiograms obtained prior to revascularization included lesion length, assessment of calcification using a semi-quantitative scoring system, and reference vessel diameter (RVD) measurement. Delta RVDs were assessed subtracting distal RVDs from proximal RVDs. A total of 197 infrapopliteal lesions in 105 CLI patients (n=106 limbs) were assessed. Of these, 136 lesions were treated by endovascular means. RESULTS The average length of treated lesions was 87.1±43.8 mm in stenoses and 124.0±78.3 mm in chronic occlusions (p<0.001). Mean RVD proximal to the lesions was 1.88 mm whereas it was 1.66 mm distal to the lesions (p≤0.03). Mean arterial calcification was 1.15. CONCLUSION This prospective angiographic series underlines the complex nature and extensive longitudinal involvement of infrapopliteal lesions in CLI patients. These findings should be taken into consideration for anti-restenosis concepts in this challenging subgroup of peripheral artery disease patients.
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Affiliation(s)
- Frederic Baumann
- Clinical and Interventional Angiology, Swiss Cardiovascular Center, Inselspital, University Hospital of Bern, Switzerland
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Misra S, Lookstein R, Rundback J, Hirsch AT, Hiatt WR, Jaff MR, White CR, Conte M, Geraghty P, Patel M, Rosenfield K. Proceedings from the Society of Interventional Radiology research consensus panel on critical limb ischemia. J Vasc Interv Radiol 2013; 24:451-8. [PMID: 23522155 DOI: 10.1016/j.jvir.2012.10.028] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/24/2012] [Revised: 10/19/2012] [Accepted: 10/22/2012] [Indexed: 12/20/2022] Open
Affiliation(s)
- Sanjay Misra
- Department of Radiology, Division of Vascular and Interventional Radiology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.
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Abstract
Technological advances in the past decade have shifted revascularization strategies from traditional open surgical approaches toward lower-morbidity percutaneous endovascular treatments for patients with lower extremity peripheral arterial disease (PAD). The continuing advances in stent design, more than any other advances, have fueled the growth of catheter-based procedures by improving the safety, durability, and predictability of percutaneous revascularization. Although the 2007 TransAtlantic Inter-Society Consensus (TASC) guidelines recommend endovascular therapy for type A and B aortoiliac and femoropopliteal lesions, recent developments in stent technology and increased experience of interventionists have suggested that a strategy of endovascular therapy first is appropriate in experienced hands for TASC type D lesions. The role of endovascular interventions is also expanding in the treatment of limb-threatening ischemia.
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In-Stent Restenosis in the Superficial Femoral Artery. Ann Vasc Surg 2013; 27:510-24. [DOI: 10.1016/j.avsg.2012.09.005] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/14/2012] [Revised: 08/07/2012] [Accepted: 09/16/2012] [Indexed: 11/20/2022]
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Bifurcated coronary stents for infrapopliteal angioplasty in critical limb ischemia. J Vasc Surg 2013; 57:1006-13. [DOI: 10.1016/j.jvs.2012.09.080] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2012] [Revised: 09/25/2012] [Accepted: 09/30/2012] [Indexed: 11/21/2022]
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Mwipatayi BP, Thomas S, Angel D, Wong J, Vijayan V. Stent outcomes for infrapopliteal arterial occlusive disease. Vascular 2013; 21:121-8. [PMID: 23518851 DOI: 10.1177/1708538113478734] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
This study aimed to determine if the different stent types used in the treatment of infrapopliteal arterial occlusive disease provide any significant advantage over one another at 6 and 12-month follow-up. Consecutive patients undergoing stenting of infrapopliteal lesions were enrolled into a non-randomised prospective registry and followed-up for 1 year. Outcome measures included binary restenosis, target lesion revascularisation, major amputation, and change in Rutherford-Becker score and ankle-brachial index (ABI).Thirty-three patients were enrolled including four patients with bilateral disease. There were 20 target vessels in the drug-eluting stent (DES) group, 13 target vessels in the balloon-expandable bare metal stent (BE-BMS) group and 14 target vessels in the self expandableb are metal stent (SE-BMS) group. Most of the patients in the study were octogenarians except in the SE-BMS group where the mean age was 73 ± 9 years. At 12 months, seven patients had died (DES = 6, BE-BMS = 1) from cardiac and cancer-related diseases. In-stent and peri-stent binary restenosis were non-statistically different between all three groups. There was a nonstatistically significant trend towards higher target vessel revascularisation in the BE-BMS group. Survival curves in all stent types demonstrated restenosis to occur within the first 6 months post-procedure. There was no significant difference in the change in Rutherford-Becker score or ABI between the groups. No major limb amputations occurred during the 12-month period. In conclusion,we did not detect a significant difference in stent performance between the different stent types used to treat infrapopliteal arterial occlusive disease. The choice of stent did not seem to affect patient survival or major amputation-free survival at 1-year follow-up.
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Scheinert D, Katsanos K, Zeller T, Koppensteiner R, Commeau P, Bosiers M, Krankenberg H, Baumgartner I, Siablis D, Lammer J, Van Ransbeeck M, Qureshi AC, Stoll HP. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol 2013. [PMID: 23194941 DOI: 10.1016/j.jacc.2012.08.989] [Citation(s) in RCA: 200] [Impact Index Per Article: 16.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
OBJECTIVES The study investigated the efficacy and safety of a balloon expandable, sirolimus-eluting stent (SES) in patients with symptomatic infrapopliteal arterial disease. BACKGROUND Results of infrapopliteal interventions using balloon angioplasty and/or bare stents are limited by a relatively high restenosis rate, which could be potentially improved by stabilizing the lesion with a SES. METHODS Two hundred patients (total lesion length 27 ± 21 mm) were randomized to infrapopliteal SES stenting or percutaneous transluminal balloon angioplasty (PTA). The primary endpoint was 1-year in-segment binary restenosis by quantitative angiography. RESULTS Ninety-nine and 101 patients (mean age 73.4 years; 64% diabetics) were randomized to SES and PTA, respectively (8 crossover bailout cases to SES). At 1 year, there were lower angiographic restenosis rates (22.4% vs. 41.9%, p = 0.019), greater vessel patency (75.0% vs. 57.1%, p =0.025), and similar death, repeat revascularization, index-limb amputation rates, and proportions of patients with improved Rutherford class for SES versus PTA. CONCLUSIONS SES implantation may offer a promising therapeutic alternative to PTA for treatment of infrapopliteal peripheral arterial disease.
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Affiliation(s)
- Dierk Scheinert
- Department for Angiology, Park-Krankenhaus Leipzig-Südost GmbH, Leipzig, Germany.
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Spiliopoulos S, Fragkos G, Katsanos K, Diamantopoulos A, Karnabatidis D, Siablis D. Long-term outcomes following primary drug-eluting stenting of infrapopliteal bifurcations. J Endovasc Ther 2012; 19:788-96. [PMID: 23210878 DOI: 10.1583/jevt-12-3993r.1] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
PURPOSE To investigate the outcomes following primary deployment of drug-eluting stents (DES) for the treatment of infrapopliteal bifurcation lesions in patients suffering from critical limb ischemia (CLI). METHODS This was a retrospective study of a registry enrolling all patients suffering from chronic infrapopliteal artery disease and undergoing treatment of tibial bifurcation lesions with DES using 3 techniques: balloon and stent (single stent), T-shape double-stent, and culotte double-stent. The analysis included 39 CLI patients (32 men; mean age 69 ± 10 years) who underwent primary stenting of 41 infrapopliteal bifurcations. Most patients (29, 70.7%) were classified as Rutherford category 4. The mean lesion length was 31.3 ± 13.1 mm. The primary endpoints were amputation-free survival, target lesion revascularization (TLR)-free survival, angiographic 2-vessel primary patency (2VPP), and 1-vessel primary patency (1VPP). Secondary endpoints included survival and angiographic binary restenosis. A Cox regression analysis was performed to identify independent predictors influencing outcomes RESULTS Technical success was achieved in all cases. The mean clinical and angiographic follow-up intervals were 47.5 ± 14.8 and 17.5 ± 12.5 months, respectively. According to the Kaplan-Meier analysis, overall survival, amputation-free survival, and TLR-free survival estimates were 79.5%, 84.3%, and 58.0%, respectively, at 5 years. At 12, 24, and 36 months, the 2VPP rates were 77.2%, 47.5%, and 33.9%, and the 1VPP rates were 84.0%, 65.5%, and 54.5%, respectively. Binary restenosis rates were 26.4%, 57.3%, and 82.2% at 12, 24, and 36 months; restenotic lesions were mainly detected at the origin of the bifurcations. The regression model did not identify any independent predictors influencing outcome. CONCLUSION DES application for below-the-knee bifurcation lesions was safe and resulted in satisfactory long-term angiographic and clinical outcomes comparable to those reported following infrapopliteal endovascular treatment.
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Affiliation(s)
- Stavros Spiliopoulos
- Department of Diagnostic and Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece.
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New Treatments for Infrapopliteal Disease: Devices, Techniques, and Outcomes So Far. Cardiovasc Intervent Radiol 2012; 35:715-24. [DOI: 10.1007/s00270-012-0412-2] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/16/2011] [Accepted: 04/20/2012] [Indexed: 11/25/2022]
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Kawarada O, Fujihara M, Higashimori A, Yokoi Y, Honda Y, Fitzgerald PJ. Predictors of adverse clinical outcomes after successful infrapopliteal intervention. Catheter Cardiovasc Interv 2012; 80:861-71. [DOI: 10.1002/ccd.24370] [Citation(s) in RCA: 110] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/12/2011] [Revised: 01/07/2012] [Accepted: 02/12/2012] [Indexed: 11/09/2022]
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Ruzsa Z, Pintér L, Kolvenbach R. Retrograde transpedal stenting of the tibioperoneal trunk in critical limb ischemia. Catheter Cardiovasc Interv 2012; 80:1105-11. [DOI: 10.1002/ccd.23427] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/19/2011] [Accepted: 10/17/2011] [Indexed: 11/06/2022]
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30
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Werner M, Schmidt A, Freyer M, Bausback Y, Bräunlich S, Friedenberger J, Schuster J, Botsios S, Scheinert D, Ulrich M. Sirolimus-Eluting Stents for the Treatment of Infrapopliteal Arteries in Chronic Limb Ischemia: Long-term Clinical and Angiographic Follow-up. J Endovasc Ther 2012; 19:12-9. [DOI: 10.1583/11-3665.1] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/14/2022]
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Katsanos K, Diamantopoulos A, Siablis D. Commentary: Prime Time for Infrapopliteal Drug-Eluting Stents? J Endovasc Ther 2012; 19:20-2. [DOI: 10.1583/11-3665c.1] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/14/2022]
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Karnabatidis D, Spiliopoulos S, Katsanos K, Siablis D. Below-the-knee drug-eluting stents and drug-coated balloons. Expert Rev Med Devices 2012; 9:85-94. [PMID: 22145843 DOI: 10.1586/erd.11.67] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
Endovascular procedures have evolved to the mainstream treatment of choice for revascularization of infrapopliteal obstructive disease, especially in patients suffering from critical limb ischemia and multiple comorbidities. However, standard balloon angioplasty is limited by the potential of a suboptimal acute outcome due to elastic recoil and/or flow-limiting dissection, followed by neointimal hyperplasia and progressive vascular restenosis even in the case of bare-metal stent use. Drug-eluting stents and drug-coated balloons are emerging endovascular technologies with the promise of significant inhibition of vessel restenosis and improved clinical outcomes. The current review outlines the drug-eluting properties of those instruments and summarizes the currently available clinical data. The authors critically appraise the current status and also provide a glimpse of the near future of endovascular below-the-knee treatments.
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Affiliation(s)
- Dimitris Karnabatidis
- Department of Radiology, Angiography Suite, Patras University Hospital, Rion, Greece.
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Setacci C, de Donato G, Teraa M, Moll F, Ricco JB, Becker F, Robert-Ebadi H, Cao P, Eckstein H, De Rango P, Diehm N, Schmidli J, Dick F, Davies A, Lepäntalo M, Apelqvist J. Chapter IV: Treatment of Critical Limb Ischaemia. Eur J Vasc Endovasc Surg 2011; 42 Suppl 2:S43-59. [DOI: 10.1016/s1078-5884(11)60014-2] [Citation(s) in RCA: 99] [Impact Index Per Article: 7.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
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Ward TJ, Lookstein RA. Drug-eluting stents for infrapopliteal arterial disease in the setting of critical limb ischemia. Expert Rev Cardiovasc Ther 2011; 9:1339-46. [PMID: 21985546 DOI: 10.1586/erc.11.125] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Peripheral artery disease is increasingly prevalent with disease presentations ranging from the asymptomatic patient to the patient with an ischemic or threatened lower extremity. The role of the vascular specialist treating the peripheral artery disease patient is to create or maintain straight-line or uninterrupted blood flow to the extremities in order to preserve patient mobility and the ability of the leg to heal in the setting of trauma or infection. Although autologous-vein surgical bypass grafting has long been viewed as the first-line treatment, endovascular approaches have become increasingly popular owing to technological advances, including the advent of drug-eluting stents. The angiographic and clinical results including symptom improvement, wound healing, limb salvage rates, cost considerations and current ongoing clinical research will be discussed.
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Affiliation(s)
- Thomas J Ward
- Department of Interventional Radiology, The Mount Sinai Medical Center, One Gustave L Levy Place, Box 1234, New York, NY 10029-6574, USA
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Abstract
Critical limb ischemia (CLI) represents the most severe clinical manifestation of peripheral arterial disease, defined as the presence of chronic ischemic rest pain, ulcers, or gangrene attributable to objectively proven arterial occlusive disease. The dominant pathology underlying CLI is atherosclerosis, distributed at multiple levels along the length of the lower extremity and with a propensity for involvement of the tibial vessels in the leg and the small vessels of the foot. To achieve limb salvage in patients with CLI, revascularization of the affected limb is generally required. In contemporary practice, endovascular techniques are rapidly replacing surgical bypass as the first option for revascularization for CLI based on high technical success rates and low rates of procedure-related morbidity and mortality. This review will describe the clinical strategy of the authors who have adopted an endovascular-first approach to revascularization in treating patients with CLI and summarize the clinical outcomes of endovascular therapy in this population.
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Abstract
Diagnosis and treatment of critical limb ischemia (CLI) is increasingly important as the average age of the world population and the incidence of diabetes and metabolic syndrome increases. Fortunately, most patients will not progress to this stage of peripheral arterial disease, yet if left untreated, there is a high risk of future cardiovascular events. At the point of ischemic rest pain or tissue loss, there are significant implications for morbidity and mortality. There is a high prevalence of multisegment occlusive disease in the CLI patient with the infrapopliteal vessels frequently involved. Revascularization of the affected limb is of utmost importance as the prospects of wound healing and relief of ischemic rest pain are poor without reestablishing continuous flow to the distal extremity. With the advent of endovascular devices designed to treat this vexing problem, the ability to successfully treat this difficult patient population with less procedural morbidity has been greatly enhanced.
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Kawarada O, Yokoi Y, Higashimori A, Waratani N, Waseda K, Honda Y, Fitzgerald PJ. Stent-assisted below-the-ankle angioplasty for limb salvage. J Endovasc Ther 2011; 18:32-42. [PMID: 21314346 DOI: 10.1583/10-3214.1] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
Abstract
PURPOSE To report the clinical outcome of stent-assisted below-the-ankle angioplasty for limb salvage in the setting of critical limb ischemia (CLI). METHODS A retrospective single-center study was conducted of 40 critical ischemic limbs in 31 patients (mean age 67 ± 8 years, range 46-94) undergoing below-the-ankle stent-assisted angioplasty between April 2006 and April 2009. Coronary bare metal stents were implanted in cases of failed balloon angioplasty due to significant recoil, flow-limiting dissection, abrupt closure, or repeat early reocclusion. RESULTS Technical success was 93% (37 limbs), with 3 failures to cross the occlusive lesions. Acute or subacute occlusion was evident in 9 (23%) limbs. The number of runoff vessels increased significantly (p < 0.001) from 0.6 ± 0.8 to 1.8 ± 0.8. During a clinical follow-up of 19.3 ± 11.4 months (range 1-48), the number of repeat interventions for limb salvage was 2.2 ± 1.6 (range 1-9), and a total of 1.6 ± 0.9 stents (range 1-3) were implanted in 8 dorsalis pedis arteries. Acute or subacute stent thrombosis after stenting was observed in 2 of these, and symptomatic in-stent restenosis was detected in 4, which were all treated by repeat intervention. At 6, 12, and 24 months, the freedom from repeat intervention was 39.6%, 39.6%, and 35.2%, respectively. Amputation-free survival was 80.0%, 69.7%, and 62.7%, and limb salvage was 94.7%, 91.4%, and 82.1% at the same time points. Patient survival rates were 77.4%, 71.0%, and 71.0%, respectively. During a mean follow-up of 13.4 ± 12.7 months (range 1-31 months) in 7 of the 8 stented arteries, all examined stents were deformed: stent compression was evident in 5 and stent fracture in 5. However, 7 limbs undergoing dorsalis pedis artery stenting showed complete wound healing; 1 limb had a resistant wound in the heel. CONCLUSION Stent-assisted below-the-ankle angioplasty produced a satisfactory clinical outcome but with the need for repeat intervention. Thus, further refinement in endovascular technology is mandatory to reduce the need for repeat interventions and to resolve stent deformity issues.
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Affiliation(s)
- Osami Kawarada
- Department of Cardiology, Kishiwada Tokushukai Hospital, Kishiwada-city, Osaka, Japan.
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Abstract
Restenosis by myointimal hyperplasia after peripheral arterial angioplasty or stenting is a major problem limiting its long-term efficiency and patency, and may lead to recurrent symptoms. Drug-eluting devices which inhibit the proliferation of neo-intimal growth of vascular smooth muscle cells may prevent restenosis. The aim of this article is to examine the evidence in published literature on the use of drug-eluting devices in the treatment of peripheral arterial diseases. A systematic literature review was undertaken of all published literature on this subject using Medline and cross-referenced. All published relevant articles on the use of drug-eluting stents and balloons in peripheral arterial disease were used. Cochrane Central Register of Controlled Trials and electronic databases were also searched for on-going studies. Published results from randomised studies such as the SIROCCO I and II Trials and the THUNDER study, together with single cohort studies, are now available. There are on-going studies comparing drug-eluting and non-drug-eluting devices. Evidence from the published literature suggests that drug-eluting stents and balloons are safe and effective in preventing restenosis after peripheral angioplasty. However, drug-eluting devices are more expensive and many are limited to single-use only. It is anticipated that results from all the on-going studies may allow a meta-analysis to show whether these preliminary data can translate into a clinically applicable cost-effective strategy in combating restenosis after peripheral angioplasty or stenting.
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Affiliation(s)
- Y C Chan
- Division of Vascular & Endovascular Surgery, Department of Surgery, University of Hong Kong Medical Centre, Queen Mary Hospital, Hong Kong. ycchan88@ hkucc.hku.hk
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Rastan A, Tepe G, Krankenberg H, Zahorsky R, Beschorner U, Noory E, Sixt S, Schwarz T, Brechtel K, Böhme C, Neumann FJ, Zeller T. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J 2011; 32:2274-81. [PMID: 21622669 DOI: 10.1093/eurheartj/ehr144] [Citation(s) in RCA: 133] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022] Open
Abstract
AIMS Preliminary reports indicate that sirolimus-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. We conducted a prospective, randomized, multi-centre, double-blind trial comparing a polymer-free sirolimus-eluting stent with a placebo-coated bare-metal stent in patients with either intermittent claudication or critical limb ischaemia who had a de-novo lesion in an infrapopliteal artery. METHODS AND RESULTS 161 patients were included in this trial. The mean target lesion length was 31 ± 9 mm. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent-restenosis (luminal narrowing of ≥50%) detected with duplex ultrasound if not appropriate with angiography. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, and changes in Rutherford-Becker classification after 1 year. Twenty-five (15.5%) patients died during the follow-up period. One hundred and twenty-five patients reached the 1-year examinations. The 1-year primary patency rate was significantly higher in the sirolimus-eluting stent group (80.6%) than in the bare-metal stent group (55.6%, P= 0.004), and the 1-year secondary patency rates were 91.9 and 71.4% (P= 0.005), respectively. The median (interquartile range) change in Rutherford-Becker classification after 1 year was -2 (-3 to -1) in the sirolimus-eluting stent group and -1 (-2 to 0) in the bare-metal stent group, respectively (P= 0.004). CONCLUSION Mid-term patency rates of focal infrapopliteal lesions are substantially improved with sirolimus-eluting stent compared with bare-metal stent. Corresponding to the technical results, the changes in Rutherford-Becker classification reveal a significant advantage for the sirolimus-eluting stent.
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Affiliation(s)
- Aljoscha Rastan
- Abteilung Angiologie, Herz-Zentrum Bad Krozingen, Südring 15, Bad Krozingen, Germany.
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Karnabatidis D, Spiliopoulos S, Diamantopoulos A, Katsanos K, Kagadis GC, Kakkos S, Siablis D. Primary everolimus-eluting stenting versus balloon angioplasty with bailout bare metal stenting of long infrapopliteal lesions for treatment of critical limb ischemia. J Endovasc Ther 2011; 18:1-12. [PMID: 21314342 DOI: 10.1583/10-3242.1] [Citation(s) in RCA: 50] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
PURPOSE To report the long-term outcomes of a single-center prospective study investigating primary placement of everolimus-eluting metal stents for recanalization of long infrapopliteal lesions compared to a matched historical control group treated with plain balloon angioplasty and provisional placement of bare metal stents in a bailout manner. METHODS The study included 81 patients (63 men; mean age 71 years, range 45-85) suffering from critical limb ischemia (CLI) and angiographically proven long-segment (at least 1 lesion >4.5 cm) de novo infrapopliteal artery disease who underwent below-the-knee revascularization with either primary placement of everolimus-eluting stents (n = 47, 51 limbs, 102 lesions) or angioplasty and bailout bare metal stenting (n = 34, 36 limbs, 72 lesions). Clinical and angiographic follow-up was collected at regular time intervals. Primary clinical and angiographic endpoints included patient survival, major amputation-free survival, angiographic primary patency, angiographic binary restenosis (>50%), and overall event-free survival. Results were stratified according to endovascular treatment received. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding factors of heterogeneity. RESULTS Baseline demographics were well matched. No significant differences were identified between the 2 groups with regard to overall 3-year patient survival (82.2% versus 65.7%; p = 0.90) and amputation-free survival (77.1% versus 86.9%; p = 0.20). Up to 3 years, lesions fully covered with everolimus-eluting stents were associated with significantly higher primary patency [hazard ratio (HR) 7.98, 95% CI 3.69 to 17.25, p < 0.0001], reduced binary restenosis (HR 2.94, 95% CI 1.74 to 4.99, p < 0.0001), and improved overall event-free survival (HR 2.19, 95% CI 1.16 to 4.13, p = 0.015) versus the matched historical control group. CONCLUSION Primary infrapopliteal everolimus-eluting stenting for CLI treatment significantly inhibits restenosis and improves long-term angiographic patency and overall patient event-free survival compared to balloon angioplasty and bailout bare metal stenting.
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Affiliation(s)
- Dimitris Karnabatidis
- Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece.
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Rastan A, Schwarzwälder U, Noory E, Taieb FH, Beschorner U, Sixt S, Bürgelin K, Amantea P, Neumann FJ, Zeller T. Primary Use of Sirolimus-Eluting Stents in the Infrapopliteal Arteries. J Endovasc Ther 2010; 17:480-7. [DOI: 10.1583/10-3073.1] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
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Balzer JO, Khan V, Thalhammer A, Vogl TJ, Lehnert T. Below the knee PTA in critical limb ischemia results after 12 months: Single center experience. Eur J Radiol 2010; 75:37-42. [DOI: 10.1016/j.ejrad.2010.04.014] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2010] [Accepted: 03/31/2010] [Indexed: 11/25/2022]
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Peregrin JH, Kožnar B, Kováč J, Laštovičková J, Novotný J, Vedlich D, Skibová J. PTA of Infrapopliteal Arteries: Long-term Clinical Follow-up and Analysis of Factors Influencing Clinical Outcome. Cardiovasc Intervent Radiol 2010; 33:720-5. [DOI: 10.1007/s00270-010-9881-3] [Citation(s) in RCA: 75] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/04/2010] [Accepted: 04/15/2010] [Indexed: 11/28/2022]
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Preventing Leg Amputations in Critical Limb Ischemia With Below-the-Knee Drug-Eluting Stents. J Am Coll Cardiol 2010; 55:1580-9. [DOI: 10.1016/j.jacc.2009.11.072] [Citation(s) in RCA: 127] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/10/2009] [Revised: 10/30/2009] [Accepted: 11/09/2009] [Indexed: 11/17/2022]
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Allaqaband S, Kirvaitis R, Jan F, Bajwa T. Endovascular treatment of peripheral vascular disease. Curr Probl Cardiol 2009; 34:359-476. [PMID: 19664498 DOI: 10.1016/j.cpcardiol.2009.05.001] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
Peripheral arterial disease (PAD) affects about 27 million people in North America and Europe, accounting for up to 413,000 hospitalizations per year with 88,000 hospitalizations involving the lower extremities and 28,000 involving embolectomy or thrombectomy of lower limb arteries. Many patients are asymptomatic and, among symptomatic patients, atypical symptoms are more common than classic claudication. Peripheral arterial disease also correlates strongly with risk of major cardiovascular events, and patients with PAD have a high prevalence of coexistent coronary and cerebrovascular disease. Because the prevalence of PAD increases progressively with age, PAD is a growing clinical problem due to the increasingly aged population in the United States and other developed countries. Until recently, vascular surgical procedures were the only alternative to medical therapy in such patients. Today, endovascular practice, percutaneous transluminal angioplasty with or without stenting, is used far more frequently for all types of lower extremity occlusive lesions, reflecting the continuing advances in imaging techniques, angioplasty equipment, and endovascular expertise. The role of endovascular intervention in the treatment of limb-threatening ischemia is also expanding, and its promise of limb salvage and symptom relief with reduced morbidity and mortality makes percutaneous transluminal angioplasty/stenting an attractive alternative to surgery and, as most endovascular interventions are performed on an outpatient basis, hospital costs are cut considerably. In this monograph we discuss current endovascular intervention for treatment of occlusive PAD, aneurysmal arterial disease, and venous occlusive disease.
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Angioplasty or Primary Stenting for Infrapopliteal Lesions: Results of a Prospective Randomized Trial. Cardiovasc Intervent Radiol 2009; 33:260-9. [DOI: 10.1007/s00270-009-9765-6] [Citation(s) in RCA: 55] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/14/2009] [Accepted: 11/06/2009] [Indexed: 10/20/2022]
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Shammas NW. Restenosis after lower extremity interventions: current status and future directions. J Endovasc Ther 2009; 16 Suppl 1:I170-82. [PMID: 19317571 DOI: 10.1583/08-2564.1] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
Abstract
The incidence of restenosis after percutaneous peripheral interventions (PPI) varies considerably depending upon the vascular bed but appears to be highest in the femoropopliteal and tibioperoneal arteries. The restenosis process in the periphery does not appear to stop at the 6-month mark, as seen with bare metal stents in the coronary arteries, but continues for a longer time, possibly years, after the intervention. This review evaluates the incidence of restenosis following lower extremity arterial interventions and potential drugs or devices that could alter this process, including nonpharmacological (stents, cryoplasty, Cutting Balloon angioplasty, atherectomy, brachytherapy, and photodynamic therapy) and pharmacological (systemic and direct drug delivery) approaches. A global strategy to achieve optimal outcome with PPI is offered: (1) obtain excellent acute angiographic results with less dissection and recoil, (2) protect the distal tibial vascular bed, and (3) reduce smooth muscle cell proliferation with pharmacological intervention.
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Affiliation(s)
- Nicolas W Shammas
- Midwest Cardiovascular Research Foundation, Cardiovascular Medicine, Davenport, Iowa 52803, USA.
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Update on PADI trial: Percutaneous transluminal angioplasty and drug-eluting stents for infrapopliteal lesions in critical limb ischemia. J Vasc Surg 2009; 50:687-9. [DOI: 10.1016/j.jvs.2009.04.073] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/09/2009] [Revised: 04/17/2009] [Accepted: 04/24/2009] [Indexed: 11/21/2022]
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Siablis D, Karnabatidis D, Katsanos K, Diamantopoulos A, Spiliopoulos S, Kagadis GC, Tsolakis J. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome. J Vasc Interv Radiol 2009; 20:1141-50. [PMID: 19620014 DOI: 10.1016/j.jvir.2009.05.031] [Citation(s) in RCA: 95] [Impact Index Per Article: 5.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/28/2008] [Revised: 05/12/2009] [Accepted: 05/28/2009] [Indexed: 02/08/2023] Open
Abstract
PURPOSE To present the 3-year angiographic and clinical results of a prospective registry investigating the performance of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs) for critical limb ischemia (CLI) treatment. MATERIALS AND METHODS A single-center double-arm prospective registry included patients with CLI who underwent infrapopliteal revascularization with angioplasty and "bailout" use of an SES or BMS. Clinical and angiographic follow-up was scheduled at regular time intervals. Primary clinical and angiographic endpoints included mortality, limb salvage, primary patency, binary angiographic restenosis (ie, >50%), and clinically driven repeat intervention-free survival. Results were stratified according to stent type, and cumulative proportion outcomes were determined by Kaplan-Meier plots. Multivariable Cox proportional-hazards regression analysis was applied to adjust for confounding factors of heterogeneity. RESULTS In total, 103 patients were included in the analysis; 41 (75.6% with diabetes) were treated with a BMS (47 limbs; 77 lesions) and 62 (87.1% with diabetes) with an SES (75 limbs; 153 lesions). At 3 years, SES-treated lesions were associated with significantly better primary patency (hazard ratio [HR], 4.81; 95% CI, 2.91-7.94; P < .001), reduced binary restenosis (HR, 0.38; 95% CI, 0.25-0.58; P < .001), and better repeat intervention-free survival (HR, 2.56; 95% CI, 1.30-5.00; P = .006) versus BMS-treated ones. No significant differences were identified between SESs and BMSs with regard to overall 3-year patient mortality (29.3% vs 32.0%; P = .205) and limb salvage (80.3% vs 82.0%; P = .507). CONCLUSIONS Infrapopliteal application of SESs for CLI significantly improves angiographic long-term patency and reduces infrapopliteal vascular restenosis versus BMSs, thereby lessening the rate of clinically driven repeat interventions.
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Affiliation(s)
- Dimitris Siablis
- Department of Radiology, University Hospital of Patras, GR 265 00, Rion, Greece.
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50
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Lumsden AB, Davies MG, Peden EK. Medical and endovascular management of critical limb ischemia. J Endovasc Ther 2009; 16:II31-62. [PMID: 19624074 DOI: 10.1583/08-2657.1] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022]
Abstract
Critical limb ischemia (CLI) is the term used to designate the condition in which peripheral artery disease has resulted in resting leg or foot pain or in a breakdown of the skin of the leg or foot, causing ulcers or tissue loss. If not revascularized, CLI patients are at risk for limb loss and for potentially fatal complications from the progression of gangrene and the development of sepsis. The management of CLI requires a multidisciplinary team of experts in different areas of vascular disease, from atherosclerotic risk factor management to imaging, from intervention to wound care and physical therapy. In the past decade, the most significant change in the treatment of CLI has been the increasing tendency to shift from bypass surgery to less invasive endovascular procedures as first-choice revascularization techniques, with bypass surgery then reserved as backup if appropriate. The goals of intervention for CLI include the restoration of pulsatile, inline flow to the foot to assist wound healing, the relief of rest pain, the avoidance of major amputation, preservation of mobility, and improvement of patient function and quality of life. The evaluating physician should be fully aware of all revascularization options in order to select the most appropriate intervention or combination of interventions, while taking into consideration the goals of therapy, risk-benefit ratios, patient comorbidities, and life expectancy. We discuss the incidence, risk factors, and prognosis of CLI and the clinical presentation, diagnosis, available imaging modalities, and medical management (including pain and ulcer care, pharmaceutical options, and molecular therapies targeting angiogenesis). The endovascular approaches that we review include percutaneous transluminal angioplasty (with or without adjunctive stenting); subintimal angioplasty; primary femoropopliteal and infrapopliteal deployment of bare nitinol, covered, drug-eluting, or bioabsorbable stents; cryoplasty; excimer laser-assisted angioplasty; excisional atherectomy; and cutting balloon angioplasty.
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Affiliation(s)
- Alan B Lumsden
- Department of Cardiovascular Surgery, Methodist DeBakey Heart and Vascular Center, The Methodist Hospital, 6550 Fannin Street, Suite 1401, Houston, TX 77030, USA.
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