Both the performance of electrophysiological examinations and the implantation of cardiac devices (pacemakers, implantable cardioverter-defibrillator [ICDs], and cardiac resynchronization therapy defibrillator [CRT-D] systems) are associated with vascular punctures. This article provides an overview of possible vascular complications and their management from the perspective of angiology. The most common access site for invasive electrophysiological procedures is usually via the femoral veins and/or arteries. Puncture of the brachial vessels is a possible but rarely used alternative. For implantation of transvenous cardiac devices, access via the cephalic vein or axillary vein is used. The electrodes located in the venous vascular system represent a foreign material and increase the risk of thrombus formation in the affected vein. Punctures of the femoral vessels can lead to bleeding, thrombosis and the formation of arteriovenous fistulas or pseudoaneurysms (aneurysma spurium). Venous thromboses can occur postprocedurally. The correct puncture technique is essential to avoid complications. Ultrasound-guided puncture also significantly reduces the rate of vascular complications.

This study aimed to describe oral anticoagulant (OAC) use among patients with venous thromboembolism (VTE).

This study included Medicare fee-for-service beneficiaries (data from 1/1/2014-12/31/2019) newly diagnosed with VTE. Factors associated with being untreated with OACs in the first month from VTE (vs. OAC-treated), with receiving direct-acting OACs ([DOACs] vs. warfarin), and with extended OAC treatment (>3 months) were assessed using multivariable logistic regressions.

Overall, 169,928 patients with VTE (50.3% OAC-untreated) were included. Among the 49.7% OAC-treated patients, 74.0% used DOACs and 62.5% had extended OAC treatment. Factors associated with being untreated with OACs in the first month from VTE (odds ratio; 95% confidence interval) included Hispanic ethnicity (vs. White;1.35; 1.29-1.42), having part D low-income subsidy (1.14; 1.07, 1.20), and comorbidities such as cardiovascular diseases. Among the OAC-treated cohort, patients with index VTE diagnosis in the emergency room (vs. outpatient) setting had higher odds of receiving DOAC vs. warfarin; patients with pulmonary embolism diagnosis (vs. deep vein thrombosis) had higher odds of extended OAC treatment.

In this study of Medicare patients newly diagnosed with VTE, half of the patients were not treated with OAC in the first month from initial diagnosis. Factors such as Hispanic ethnicity, having low-income subsidy, and comorbidity burden were found to be associated with being untreated with OAC. Among OAC-treated patients, the majority were treated with DOAC vs. warfarin. Interestingly, more than a third of OAC-treated patients were not treated beyond 3 months, which warrants further investigation.

Real-world data on adverse drug reactions (ADRs) associated with idarucizumab and andexanet alfa are limited.

This study aimed to assess the frequency, the characteristics and clinical and demographic factors associated with ADRs related to their use.

This is a retrospective analysis of ADR reports collected in Vigibase® until May 31, 2023. Multivariable logistic regression estimated reporting odds ratios (RORs) for serious ADRs, death, and thromboembolic events according to demographical and clinical covariates.

A total of 1095 Individual Case Safety Reports (ICSRs) reporting idarucizumab (72%) or andexanet alfa (28%) as suspected/interacting agents were collected. Most of the subjects were males (44.5%), with a median age of 78 years, and exposed to only one suspected/interacting medication (73.6%). ADRs were defined as serious in 88.6% of cases, with a total of 614 (56.1%) fatal cases. Compared to patients without concomitant medications, probability of serious ADRs and death were both higher in those receiving ≥ 5 concomitant medications in the idarucizumab subgroup (ROR 4.04 and 1.66, respectively) and in those receiving 1-4 concomitant medications in the andexanet alfa subgroup (ROR 5.66 and 4.80, respectively). Moreover, the probability of thromboembolic events was significantly lower for subjects aged > 75 years (ROR for 75-84 years 0.55; ROR for ≥ 85 years 0.50).

In real-world, ADRs associated with idarucizumab and andexanet alfa use are generally serious, resulting in death in a high percentage of subjects.

Clinicians should pay particular attention when managing individuals needing these drugs, especially if vulnerable and requiring polytherapy.

Direct oral anticoagulants (DOACs) are increasingly being used over low molecular weight heparin (LMWH) and vitamin K antagonists for the treatment of venous thromboembolism (VTE). The objective of this study was to examine predictors of anticoagulant type (DOAC vs. LMWH) prescribed at discharge from the emergency department (ED) among patients diagnosed with VTE in the ED.

We conducted a retrospective chart review of adult (>17 years) patients discharged from an Ontario, Canada ED in a tertiary care centre with an ED diagnosis of deep vein thrombosis or pulmonary embolism from January 2019 to December 2021. A multivariable logistic regression model was used to examine the predictors of the anticoagulant (DOAC vs. LMWH) prescribed at discharge. Covariables included: age, sex, history of major bleeding, history of cancer, and previous anticoagulation.

VTE was confirmed in 390 ED visits by 365 unique patients. Among unique patients, 239 (65.5 %) patients were discharged from the ED and included in analysis. Of the 239 patients included, 12.1 % of patients were over the age of 80, 46.4 % were female and 29.7 % had a history of cancer. The majority of patients discharged from the ED were prescribed DOACs (70.7 %,169/239). Cancer history was associated with anticoagulation with LMWH (vs. DOAC) on discharge (adjusted odds ratio [aOR] =12.81, 95 % CI: 6.60-25.90).

While most patients diagnosed with VTE in the ED setting were discharged with DOACs, most cancer patients included in our study were treated with LMWH over DOACs, despite increasing evidence around the efficacy and safety of DOACs in most cancer patients. Further research is needed to understand longitudinal trends in anticoagulation.

Acute pulmonary embolism is a common and potentially fatal condition in intensive care and emergency medicine. The mortality rate within the first few hours of its occurrence is particularly high; thus, even in the event of clinical suspicion, immediate initiation of diagnostics and treatment is crucial. The current European and national guidelines on acute pulmonary embolism provide valuable and practical support on this topic and form the basis of this review. A particular focus lies in the presentation of a risk-adapted and algorithm-based diagnostic and therapeutic approach. In particular, there are new recommendations regarding risk stratification and differentiated therapy, which are discussed in this article.

The risk of major bleeding from anticoagulant treatment is influenced by both the treatment and the patient's baseline risk, which is often disregarded.

To determine the excess bleeding risk in venous thromboembolism (VTE) cases during initial (0 to 6 months) and extended (6 months to 5 years) treatment compared to matched population controls without VTE or anticoagulant treatment, overall, and stratified by sex and age.

Cancer-free patients with VTE treated with direct oral anticoagulants from 2014 to 2020, along with propensity score-matched controls, were identified from nationwide Swedish registers. Excess risk of major bleeding was assessed using the incidence rate difference (IRD) calculated by subtracting the control bleeding rate from the case bleeding rate.

The matched cohort comprised 36,115 VTE cases and 36,115 controls. During initial treatment, 388 VTE cases (1.07%) and 103 controls (0.29%) experienced bleeding, IRD: 2.19 (95% confidence interval 1.89-2.49) per 100 person-years. Following rematching at 6 months, 139 cases (0.70%) and 214 controls (1.08%) experienced bleeding, IRD: 0.70 (0.52-0.89). During initial treatment, females had a higher excess bleeding risk than males, with male IRD: 1.73 (1.34-2.12) and female IRD: 2.69 (2.23-3.15). Excess bleeding risk was highest in the oldest patient population. In extended treatment, excess bleeding was not dependent on sex-male IRD: 0.60 (0.35-0.85), female IRD: 0.81 (0.54-1.08)-and did not increase with age.

The excess bleeding risk from anticoagulant treatment was high during initial treatment, particularly among females and the elderly, but lower and not influenced by sex or age during extended treatment.

The optimal management of thromboembolism (TE) in patients with nephrotic syndrome (NS) remains challenging. Until now, anticoagulation therapy for NS consisted of vitamin K antagonists (VKAs) or heparin. Data on direct oral anticoagulant (DOAC) use in NS are limited, and their safety and convenience have been well-demonstrated in other indications.

We conducted a multicenter retrospective study of adult patients with NS treated with therapeutic-dose anticoagulation between 2014 and 2022. We compared the incidences of bleeding and TE events between patients receiving DOAC and those receiving VKAs or heparin (standard-of-care [SOC]). Patients with end-stage kidney disease were excluded.

The overall population consisted of 144 patients (median [interquartile range] age of 54 [38-67] years, 34.7% women) with a median albumin level at 1.5 (1.2-1.8) g/dl and a median urinary protein-to-creatinine ratio of 8.8 (5.5-12.3)g/g. Membranous nephropathy was the main NS etiology (45.8%). No significant differences were observed between the DOAC (n = 72) and the SOC (n = 72) groups. The anticoagulant strategy was primary prophylaxis in 79.2% of patients taking DOAC and 83.3% of patients with SOC (P = 0.67). DOAC use was not associated with an increased rate of TE (4.2% vs. 0%, P = 0.25) or bleeding events (6.9% vs. 13.9%, P = 0.28) compared with the SOC group. Univariate analysis identified female sex, age > 75 years, and anticoagulant exposure > 90 days as risk factors for bleeding.

This study suggests that DOAC are safer and more effective than conventional anticoagulant strategies for both primary and secondary prophylaxis in patients with NS.

Iron deficiency anaemia (IDA) related to occult gastrointestinal tract (GIT) blood loss is associated with high rates of GIT malignancies. Major society guidelines recommend bidirectional endoscopic evaluation for all men and post-menopausal women with newly diagnosed, unexplained IDA. However, in patients prescribed direct oral anticoagulants (DOACs), the endoscopic yield, specifically the rate of high-risk findings, including colorectal cancers (CRCs) and advanced adenomas (AAs), is unknown.

Our aim is to determine the endoscopic yield, specifically the prevalence of these high-risk findings in patients presenting with new-onset unexplained IDA while on a DOAC.

This is a single-centre, retrospective analysis performed at a tertiary hospital in Australia. Between January 2015 and July 2019, 178 consecutive patients underwent endoscopic evaluation for IDA while prescribed a DOAC. Patient demographics, laboratory data, medications and endoscopic findings were summarised and compared by diagnostic yield. Associations were explored using logistic regression analysis.

CRCs were present in 2/178 (1.1% (95% confidence interval (CI): 0.1-4.0)) patients. AAs were found in 35/178 (19.6% (95% CI: 14.1-26.3)) patients. The most common AAs were tubular adenomas (45.7%), tubulovillous (31.4%) and sessile serrated adenomas (14.2%). Older age (P = 0.013) and lower ferritin levels (P = 0.009) were associated with the presence of high-risk findings.

In patients presenting with new-onset, unexplained IDA while on a DOAC, the prevalence of CRCs is lower than previously reported in studies involving populations not prescribed DOACs. Conversely, there is a higher incidence of AAs, including high-risk histological features, such as tubulovillous adenomas and sessile serrated polyps.

There is an unmet need for high-quality data from prospective studies on the safety and effectiveness of direct oral anticoagulants (DOACs) for the treatment of cerebral venous thrombosis (CVT). We aimed to compare the safety and effectiveness of DOACs versus vitamin K antagonists (VKAs) for the treatment of CVT in a setting that reflects daily clinical practice.

DOAC-CVT was an international, prospective, observational cohort study done in 65 hospitals in 23 countries across five continents. Eligible patients were adults (aged ≥18 years) with radiologically confirmed CVT starting oral anticoagulant treatment with either DOACs or VKAs, as per local practice, within 30 days after diagnosis. Exclusion criteria were previous use of anticoagulants at the time of CVT diagnosis or an absolute contraindication to DOACs (eg, pregnancy and lactation, or severe renal or liver disease). Data were collected during routine clinical visits or telephone consultations at CVT diagnosis (baseline) and at 3 months, 6 months, and 12 months after CVT diagnosis. The primary endpoint was a composite of symptomatic venous thromboembolism and major bleeding events (International Society on Thrombosis and Haemostasis criteria) at 6 months. Main outcomes were adjusted for the confounders age, renal function, active cancer, CNS infections, concomitant antiplatelet use, country of inclusion's income status, Glasgow Coma Scale score, intracranial haemorrhage, antiphospholipid antibodies, previous major bleeding, and previous venous thromboembolism using inverse probability-of-treatment weighting. This study is registered at ClinicalTrials.gov (NCT04660747) and is ongoing.

Between Jan 27, 2021, and Jan 15, 2024, 619 patients were included; 401 (65%) patients started DOAC treatment, and 218 (35%) patients started VKA treatment. 390 (63%) of 619 patients were female and 229 (37%) of 619 patients were male. Patients' median age was 41 years (IQR 28-51). 6-month follow-up data were available for 617 (>99%) of 619 patients. 12 (3%) of 401 patients in the DOAC group and seven (3%) of 218 patients in the VKA group had a primary outcome event (weighted odds ratio [OR] 0·99 [95% CI 0·37-3·38]). Three (1%) of 401 patients in the DOAC group died versus three (1%) of 218 patients in the VKA group (weighted OR 0·55 [95% CI 0·11-2·80]).

The rate of recurrent thrombosis and major bleeding did not differ between patients with CVT treated with DOACs versus VKAs. This study adds to the increasing evidence that DOACs are a reasonable treatment option for CVT alongside VKAs.

Netherlands Thrombosis Foundation.

To evaluate the risk of bleeding associated with the simultaneous administration of antidepressants (ADs) and direct oral anticoagulants (DOACs).

PubMed, Embase, and Scopus databases were searched for papers that focused on the concomitant administration of ADs and DOACs and presented data on the bleeding outcomes. The comparator group of interest was subjects who received only DOACs. Besides the overall pooled analysis, irrespective of the primary disease condition, we were also interested in studies involving patients with atrial fibrillation (AF). We therefore included studies with relevant comparisons (AD with DOACs, compared to DOACs alone), regardless of the reported underlying condition. Thereafter, we conducted a sensitivity analysis to refine estimates specific to AF. Clinical trials and observational studies were eligible. Pooled effect sizes were reported as relative risk (RR) for studies with cohort design and as odds ratio (OR) for case-control studies.

Ten studies were included. Overall pooled analysis showed that treatment with both DOAC and selective serotonin reuptake inhibitor and serotonin and norepinephrine reuptake inhibitor (SSRI/SNRI) was associated with significantly higher risk of major bleeding (cohort: RR 1.25, 95% CI: 1.07-1.47; case-control: OR 1.40, 95% CI: 1.15-1.69). The risk of intracranial bleeding was found to be increased when cohort studies were pooled (RR 1.44, 95% CI: 1.24-1.66), but not with pooling of case-control studies (OR 1.58, 95% CI: 0.43-5.75). The risk of gastrointestinal bleeding and transient ischemic attack (TIA)/ischemic stroke was comparable between the 2 groups (DOAC + SSRI/SNRI vs DOAC only group).

Our results indicate that combined SSRIs/SNRIs and DOAC treatment may be associated with increased incidence of major and intracranial bleeding, further emphasizing the importance of caution when considering their concomitant use.

Rising costs are a challenge for healthcare systems. To keep expenditure for drugs under control, in many healthcare systems, drug prescribing is continuously monitored. The Bavarian Drug Agreement (German: Wirkstoffvereinbarung or WSV) for the ambulatory sector in Bavaria (the federal state of Germany) was developed for this purpose. Physicians must reach defined drug target quotas for prescribing generic drugs and certain recommended drugs specified and measured with defined daily doses (DDD). A subgroup of physicians, known as outliers, may miss their drug targets. The objective of this qualitative study was to understand the reasons physicians miss their targets.

We identified outliers based on drug prescribing data from the association of statutory health insurance (SHI)-accredited physicians (KV). Outliers were invited to participate in semi-structured interviews.

Out of 401 outliers thus identified n = 26 physicians were interviewed. Their prescribing behaviours are affected by competing demands regarding drug decisions, such as saving staff time, costs, and discussions with patients. Often, their freedom to prescribe is limited by previous prescribers. Ease of administration of drugs not recommended also plays a role. Uncritical enthusiasm regarding the effectiveness and safety of drugs with recommendations, often reinforced by pharmaceutical marketing, leads to missed targets. Some physicians have coping strategies to avoid becoming outliers.

Investigating physicians not meeting their targets helps us understand beliefs and barriers for appropriate drug prescribing. Based on these kinds of findings, surveillance procedures can be improved, and physicians can receive support to meet targets in the future.

This trial has been registered in the German Register of Clinical Trials (DRKS: DRKS00016161; registration date 07. December 2018).

Persistence and adherence to oral anticoagulants (OACs) is crucial for its effectiveness in stroke prevention in atrial fibrillation (AF). We aimed to assess the impact of different ascertainment methods on estimated persistence rates.

We conducted a retrospective cohort study based on the Medicare claims data (01/01/2013-12/31/2019). We built an incident user cohort of OAC (apixaban, dabigatran, edoxaban, rivaroxaban, and warfarin) prescription filling. We measured OAC medication persistence and adherence using the following approaches: (1) treatment-anniversary based persistence: if there is an active prescription overlapping the 180th and 365th day with vs. without a 15-day buffer period (i.e., overlapping with 165th-195th and 350th-380th day); (2) dispensing-gap-based persistence: if there is OAC discontinuation defined as having gap between prescriptions more than a threshold (e.g., 5-60 days) and secondarily, (3) proportion of days covered (PDC) adherence: proportion of days in which patient had filled medication available over the 365-day interval.

We identified 1,398,692 patients who initiated OACs during the study interval. With the treatment-anniversary based approach, only 51.2% to 65.4% of the patients persisted with the medication for either warfarin or DOACs at 180 days, and the number dropped to 43.4% to 60.7% at 1 year. Adding a 15-day buffer period increased the treatment-anniversary based persistence rates by 6.5% to 10.5%. When the allowable gap increased from 5 to 60 days, the persistence rates increased by 36.3% to 42.4% for all OACs. Apixaban users had the highest PDC (74%-75%) over the 365 days, compared to other OACs (60%-69%).

We found that the estimated persistence rates are sensitive to the choice of ascertainment methods. When reporting and comparing persistence findings using the claims database, definitions of OAC discontinuation must be clearly delineated.

This systematic review and meta-analysis aimed to assess the diagnostic accuracy of the YEARS algorithm in excluding pulmonary embolism, as well as to compare the utilisation of advanced imaging modalities between the YEARS approach and standard clinical practice. Eligible studies were identified from multiple databases spanning July 2017 to September 2022, following the Joanna Briggs Institute methodology for diagnostic accuracy reviews. A total of 10 studies, involving approximately 14,000 participants, were included in the analysis. The YEARS algorithm demonstrated a sensitivity of 96% (95% confidence interval [CI]: 93-98%) and a specificity of 50% (95% CI: 33-67%). Additonally, the risk ratio for advanced imaging utilisation was 0.78 (95% CI: 67-90), indicating a significant reduction in imaging use. These findings suggest that the YEARS is an effective and safe strategy for managing patients with suspected pulmonary embolism.

The use of oral anticoagulants in the management of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) presents distinct therapeutic challenges and benefits. In PAH, the benefits of oral anticoagulation are uncertain, with studies yielding mixed results on their efficacy and safety. Conversely, oral anticoagulants are a cornerstone in the treatment of CTEPH, where their use is consistently recommended to prevent recurrent thromboembolic events. The choice between vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) remains a significant clinical question, as each type presents advantages and potential drawbacks. Furthermore, drug-drug interactions (DDIs) with concomitant PAH and CTEPH treatments complicate anticoagulant management, necessitating careful consideration of individual patient regimens. This review examines the current evidence on oral anticoagulant use in PAH and CTEPH and discusses the implications of DDIs within a context of multi-drug treatments, including targeted drugs in PAH.

Long-term outcome after a first venous thromboembolism (VTE) might be optimized by tailoring anticoagulant treatment duration on individual risks of recurrence and major bleeding. The L-TRRiP models (A-D) were previously developed in data from the Dutch Multiple Environment and Genetic Assessment of Risk Factors for Venous thrombosis study to predict VTE recurrence.

We aimed to externally validate models C and D using data from the United States Heart and Vascular Health (HVH) study.

Data from participants with a first VTE who discontinued initial anticoagulant therapy were used to determine model performance. Missing data were imputed, and results were pooled according to Rubin's rules. To determine discrimination, Harrell's C-statistic was calculated. To assess calibration, the observed/expected (O/E) ratio was estimated, and calibration plots were created, in which we accounted for the competing risk of death. A stratified analysis based on age <70 or >70 years was performed.

Of 1430 participants from the HVH study, 187 experienced an unprovoked VTE recurrence during follow-up. The C-statistics of L-TRRIP models C and D were 0.62 (95% CI, 0.56-0.67) and 0.61 (95% CI, 0.55-0.67), respectively. The O/E ratio (1.00; 95% CI, 0.84-1.17 and 1.09; 95% CI, 0.91-1.27, respectively) and calibration plots indicated good calibration. The discrimination was similar between participants <70 or >70 years, whereas overall calibration was lower in participants <70 years.

The L-TRRiP models showed moderate discrimination and good calibration in a different population and can be used to guide clinical decision making. To assess the added value in daily clinical practice, a management study is needed.

Direct oral anticoagulants (DOACs) interfere with coagulation assays potentially leading to inaccurate results. This study determined the effectiveness of DOAC-stop® and DOAC-remove® in overcoming DOAC interference. It aimed to investigate the extent to which apixaban, rivaroxaban, and dabigatran had an effect on thrombophilia and lupus tests using normal plasma, as well as whether DOACs interfere with true-positive results by testing abnormal controls.

Apixaban (0.03 mg/mL), rivaroxaban (0.01 mg/mL), and dabigatran (0.019 mg/mL) stock solutions were made and added to the normal pool at three different concentrations (200, 400 and 600 ng/mL) and to the abnormal controls at a single concentration. These samples and untreated DOAC controls were tested before and after adding either DOAC-stop® or DOAC-remove®. The measured parameters included protein C, protein S, antithrombin III (ATIII), DRVVS, DRVVC, PTT-LA and DOAC concentration. The normal pool spiked with DOAC was repeated seven times for each DOAC at each concentration level and the abnormal controls spiked with DOAC were repeated four times at a single concentration level for each DOAC.

In the normal pool, dabigatran and rivaroxaban affected all lupus anticoagulant tests, whereas apixaban only affected DRVVS and DRVVC. While dabigatran led to false-positive protein S deficiency and falsely elevated ATIII. Both DOAC-stop® and DOAC-remove® brought the thrombophilia results and all falsely elevated lupus anticoagulant results back within the normal range for apixaban and rivaroxaban. For dabigatran all the affected lupus anticoagulant tests remained abnormal following DOAC-remove®, unlike DOAC-stop® treatment, where only DRVVS and DRVVC at 600 ng/mL remained abnormal. In abnormal controls, all DOACs falsely elevated the lupus anticoagulant tests, whereas dabigatran caused false negative ATIII results, that were corrected (remained abnormal) with DOAC-stop® and DOAC-remove®. DOAC-stop® showed a greater reduction in lupus anticoagulant results than DOAC-remove®, causing a false-negative DRVVT ratio for rivaroxaban.

DOAC-stop® is more effective than DOAC-remove® in removing all DOACs below the reference range, whereas DOAC-remove® failed to remove dabigatran.

To assess the safety of preoperative chemoprophylaxis (PEC) in head and neck cancer (HNC) patients undergoing oncologic procedures.

Retrospective cohort study.

Tertiary academic center.

HNC patients with Caprini risk score (CRS) ≥5 who underwent inpatient surgery ≥3 hours between 2015 and 2020 were included. Patients were divided into 2 cohorts, PEC and control, based on whether or not they received a single dose of low molecular weight heparin or unfractionated heparin prior to surgery. The primary endpoint was the 30-day rate of major bleeding events.

A total of 539 patients were included; 427 patients received PEC prior to surgery. The rate of major bleeding was 6.7%. The PEC cohort was more likely to have received concurrent aspirin or ketorolac (225 of 427 patients vs 36 of 112 patients; P = .0002), greater duration of chemoprophylaxis (7.8 vs 5.0 days; P < .0001), have higher CRS (7.2 vs 6.6; P < .0001), longer operative times (596 vs 512 minutes; P < .0001), higher blood loss (265 vs 214 ml; P = .02), and higher bleeding rates when compared to the control (34 of 427 patients; P = .03). On multivariate analysis, only PEC was associated with bleeding (odds ratio, 8.74; 95% confidence interval, 1.15-66.5). The rate of VTE was 1.3% and was not significantly different between cohorts.

PEC was associated with an increase in bleeding and did not result in lower rates of VTE in patients with HNC. This study highlights the need to determine the optimal regimen of chemoprophylaxis in this patient cohort.

Limited data exists on the safety and efficacy with the concomitant use of 4 factor prothrombic complex concentrate (4F-PCC) and andexanet alfa (AA). This case series describes 7 patients at our institution who received both 4F-PCC and AA for the management of life-threatening bleeding associated with apixaban or rivaroxaban. Four patients received AA due to worsening bleeding after 4F-PCC. Of the 7 patients in this case series, 1 had a documented thrombotic event which was an acute ischemic stroke. The thrombotic event rate in our case series was similar to the incidence of thrombotic events reported with the use of AA alone. In-hospital mortality occurred in 2 of 7 patients with 1 additional patient discharged to hospice care.

Due to their very wide range of indications, anticoagulants are one of the most commonly used drug groups. Although these drugs are characterized by different mechanisms of action, the most common complication of their use is still bleeding episodes, the frequency of which depends largely on the clinical condition of the patient using such therapy. For this reason, to this day, the best method of preventing bleeding complications remains the assessment of bleeding risk using scales such as HAS-BLED. There are many reports in the literature assessing the occurrence of this type of complication after the use of drugs affecting the coagulation process, as well as many reports comparing individual groups of drugs with different mechanisms of action. However, there are still no clear guidelines that would indicate which group of anticoagulants should be preferred in particular groups of patients. The aim of our article is to summarize the data collected so far regarding the safety of using specific groups of anticoagulants and the frequency of bleeding complications after their use.

The rising costs of drugs are putting health care systems under pressure. We report on the Bavarian Drug Agreement, which employs prescribing targets for preferred and generic drugs in ambulatory care. Under this agreement, providers are regularly profiled with individual feedback but also possible sanctions. We investigated the degree to which targets were being met (or not) and why failure occurred.

We analysed prescribing data aggregated by practice for the quarter 1/2018. We chose eight specialisation groups and analysed their drug targets with a high prescribing volume, widely missed drug targets (<90%), and drugs preventing drug target achievement. Characterisation of drug targets and preventing drugs was undertaken.

Drug targets with a high prescribing volume are mostly achieved, while highly missed drug targets mostly do not affect the main indication area of the specialisation groups considered. Generic drug targets seem to be more easily achieved than recommended drug targets. Paediatrics accounts for the largest number of missed drug targets.

The Bavarian tool implemented uses the prescribing volume (DDD) and price components to evaluate the prescription behaviour of physicians. Well-established drugs with demonstrated effectiveness, safety, and lower costs are preferred. Nevertheless, me-too drugs, combination drugs, costly innovations with unclear value, and drugs with application methods of variable convenience challenge the drug prescribers and are reasons for missed drug targets.

The treatment of proximal deep vein thrombosis (DVT) of the lower limbs includes an initial management phase, covering the first 1 to 3 weeks, a primary treatment phase, lasting a minimum of 3 months, and a secondary treatment phase for those patients requiring continuing anticoagulation beyond the first 3 to 6 months. During the initial phase most patients with DVT can be managed as outpatients. Exclusion criteria for home treatment include high risk of bleeding, limb threatening DVT or other conditions requiring hospitalisation. Anticoagulant drugs represent the mainstay of treatment and include parenteral drugs such as unfractionated heparin or low molecular weight heparin, and oral drugs such as the vitamin K antagonists and the direct oral anticoagulants (DOACs). DOACs are currently recommended as the first line of treatment for proximal DVT of the lower limbs, with no preference for one DOAC over another. Factors to consider when choosing the anticoagulant strategy include, among others, renal and liver function, underlying diseases such as cancer or the antiphospholipid syndrome, and patient preferences. Indefinite duration of anticoagulation beyond the first 3 to 6 months is recommended for patients with unprovoked DVT and patients with permanent, chronic risk factors. Two DOACs, namely apixaban and rivaroxaban, can be administered at low doses for the secondary prevention of DVT. Elastic compression stockings (ECS) have been used for decades in patients with proximal DVT with the aim of counteracting the venous hypertension generated by the vascular disorder and reducing leg edema and to prevent the post-thrombotic syndrome.

Home treatment is considered safe in acute pulmonary embolism (PE) patients selected by a validated triage tool (e.g. simplified PE severity index score or Hestia rule), but there is uncertainty regarding the applicability in underrepresented subgroups. The aim was to evaluate the safety of home treatment by performing an individual patient-level data meta-analysis.

Ten prospective cohort studies or randomized controlled trials were identified in a systematic search, totalling 2694 PE patients treated at home (discharged within 24 h) and identified by a predefined triage tool. The 14- and 30-day incidences of all-cause mortality and adverse events (combined endpoint of recurrent venous thromboembolism, major bleeding, and/or all-cause mortality) were evaluated. The relative risk (RR) for 14- and 30-day mortalities and adverse events is calculated in subgroups using a random effects model.

The 14- and 30-day mortalities were 0.11% [95% confidence interval (CI) 0.0-0.24, I2 = 0) and 0.30% (95% CI 0.09-0.51, I2 = 0). The 14- and 30-day incidences of adverse events were 0.56% (95% CI 0.28-0.84, I2 = 0) and 1.2% (95% CI 0.79-1.6, I2 = 0). Cancer was associated with increased 30-day mortality [RR 4.9; 95% prediction interval (PI) 2.7-9.1; I2 = 0]. Pre-existing cardiopulmonary disease, abnormal troponin, and abnormal (N-terminal pro-)B-type natriuretic peptide [(NT-pro)BNP] at presentation were associated with an increased incidence of 14-day adverse events [RR 3.5 (95% PI 1.5-7.9, I2 = 0), 2.5 (95% PI 1.3-4.9, I2 = 0), and 3.9 (95% PI 1.6-9.8, I2 = 0), respectively], but not mortality. At 30 days, cancer, abnormal troponin, and abnormal (NT-pro)BNP were associated with an increased incidence of adverse events [RR 2.7 (95% PI 1.4-5.2, I2 = 0), 2.9 (95% PI 1.5-5.7, I2 = 0), and 3.3 (95% PI 1.6-7.1, I2 = 0), respectively].

The incidence of adverse events in home-treated PE patients, selected by a validated triage tool, was very low. Patients with cancer had a three- to five-fold higher incidence of adverse events and death. Patients with increased troponin or (NT-pro)BNP had a three-fold higher risk of adverse events, driven by recurrent venous thromboembolism and bleeding.

Aims: Our aims were to describe the clinical characteristics, adverse clinical events, healthcare resource utilization (HCRU) and costs of patients with major bleeding during direct Factor Xa inhibitor (FXai) use. Methods: This is a retrospective cohort study that included secondary data from computerized health records of seven Spanish Autonomous Communities. Patients with a first major bleeding during treatment with a direct FXai were analyzed during a 3-year period. Results: Of 8972 patients taking a direct FXai, 470 (5.24%) had major bleeding (mean age (SD) 77.93 (9.71) years, 61.06% women). The most frequent indications for using FXais were atrial fibrillation (78.09%) and venous thromboembolism (17.66%). Among those with major bleeding, 88.94% presented with gastrointestinal bleeding, 6.81% intracranial bleeding, 2.13% trauma-related bleeding and 4.26% other major bleeding. Prothrombin complex concentrates were used in 63.19%, followed by transfusion of blood products (20.21%) and Factor VIIa (7.66%). In total, 4.26% of patients died in the hospital due to the first major bleeding. At the study end (after 3-year follow-up), 28.94% of the patients had died, 12.34% had a myocardial infarction and 9.15% an ischemic stroke. At year 3, overall bleeding cost was EUR 5,816,930.5, of which 79.74% accounted for in-hospital costs to treat the bleeding episode. Conclusions: Despite the use of replacement agents being high, major events were common, with a 29% mortality at the end of the follow up, and HCRU and costs were high, evidencing the need for new reversal treatment strategies.

Pulmonary embolism (PE) and deep venous thrombosis (DVT) are the two most important manifestations of venous thromboembolism (VTE). DVT remains a significant condition since associated morbidity is significant and has elevated healthcare-related costs.

A retrospective cohort study was conducted among DVT patients admitted to Tikur Anbessa Specialized Hospital, Zewditu Memorial Hospital and St. Paul's Hospital Millennium Medical College on follow-up from July 1, 2017, to July 01, 2020. Data on sociodemographic characteristics, types of DVT, laboratory findings, medications, risk factors of DVT, complications and outcomes of DVT were collected. The data were analyzed using SPSS version 25. Multivariate logistic regression analysis was conducted to determine predictors of DVT recurrence and major bleeding. A P value < 0.05 was considered to identify significant predictors.

The mean age of the participants was 45.2 years, with SD of 15.36. The major causes of DVT included immobilization (29.9%), previous surgery (27.5%) and cancer (21.1%). The DVT recurrence rate was 22.5%. Nine (2.2%) of the participants died, and 19.9% developed complications. Bilateral DVT (Adjusted odds ratio (AOR) = 2.8, 95% Confidence interval (CI) = 1.14, 6.66), obesity (AOR = 3.3, 95% CI = 1.15, 9.59), hypertension (AOR = 6.5, 95% CI = 2.90, 14.70) and retroviral infection (AOR = 6.3, 95% CI = 2.34, 16.94) were predictors of recurrent DVT. Nineteen (4.7%) patients had major bleeding, and patients with bilateral DVT, active cancer and terminal age had an increased risk of major bleeding.

The overall DVT recurrence rate was alarmingly high and further complicated by PE, post thrombotic syndrome and chronic vein insufficiency, resulting in a 2.2% death rate. Major bleeding after DVT and PE remained high. Close monitoring should be performed for patients with advanced age, active cancer, bilateral DVT, retroviral infection, obesity and hypertension to prevent the recurrence of DVT and major bleeding.

Atrial fibrillation (AF) is a predominant contributor to morbidity and mortality, and stroke prevention remains the mainstay for the management of AF. The precise mechanism involved in thrombus formation remains unknown. However, factors such as stretch-induced fibrosis, endothelial dysfunction, disordered atrial contractions, and pro-thrombotic states have been postulated for the development of AF. Various risk assessment strategies have been acknowledged for determining the risk of stroke in AF, of which the congestive heart failure, hypertension, age ≥75, diabetes, stroke, vascular disease, age between 65-74, and female sex (CHA2DS2-VASc) score remains the ultimate risk stratification tool. For the longest time, vitamin K antagonists (VKA) were the only oral anticoagulants available but were associated with an increased risk of bleeding. Recently, direct oral anticoagulants (DOACs) were approved and considered more efficient and safer than or as secure as warfarin in stroke prevention and lowering intra-cranial bleeding events. The pharmacodynamics and pharmacokinetics of DOACs were also clarified in this article. This review article compiles current evidence-based data on the role of DOACs, uncovering their underlying mechanisms, and comparing their efficacy with warfarin in stroke prevention in AF.

Oral anticoagulants (OACs) and aspirin can trigger bleeding events when used alone or in combination. The purpose of this study was to compare the risk of any type of bleeding in individuals exposed to a combination of OAC and aspirin with the risk in those taking an OAC or aspirin alone.

MEDLINE and Web of Science were queried in January 2021 for eligible articles. Studies were included if they were either randomized controlled trials (RCTs) or observational studies and evaluated the number of any bleeding events in two groups, one with exposure to both OAC and aspirin and one with exposure to OAC alone or aspirin alone. Pooled odds ratios were calculated using a random-effects model.

Forty-two studies were included. In an analysis of 15 RCTs and 19 observational studies evaluating OAC plus aspirin versus OAC alone, a significant difference in the risk of bleeding was observed in the combination groups, with an odds ratio [OR] of, 1.36 (95% CI, 1.15-1.59) for RCTs and an OR of 1.42 (95% CI-, 1.09-1.87) for observational studies. When OAC plus aspirin was compared to aspirin alone, a higher rate of bleeding was found in the combination group (OR, 2.36; 95%CI, 1.91-2.92) in the analysis of 15 RCTs, but no significant difference was found among 10 observational studies (OR, 1.93; 95% Cl, 0.99-3.75).

The risk of any type of bleeding was significantly increased among patients taking aspirin plus OAC compared to those taking OAC alone in both RCTs and observational studies. Evaluation of RCTs comparing OAC plus aspirin to aspirin alone suggests increased bleeding risk as well.

Is withholding anticoagulation for patients with isolated or incidental subsegmental pulmonary embolism clinically and cost-effective compared with full anticoagulation for 3 months?

There has been an increase in the diagnosis of subsegmental pulmonary embolism since the advent of computed tomography pulmonary angiogram to investigate patients with suspected pulmonary embolism. Subsegmental pulmonary embolism is not often detectable with older nuclear medicine-based diagnostic imaging for ventilation/perfusion mismatch. The case fatality of pulmonary embolism has reduced as subsegmental pulmonary embolism diagnoses from computed tomography pulmonary angiogram have increased. There is growing equipoise about the optimal treatment for patients with subsegmental pulmonary embolism, given that full anticoagulation has significant risks of bleeding and subsegmental pulmonary embolism was not often diagnosed previously with ventilation/perfusion scanning and therefore most likely left predominantly untreated prior to the introduction of computed tomography pulmonary angiogram scanning.

Determine whether withholding anticoagulation for isolated or incidental subsegmental pulmonary embolism (i.e. subsegmental pulmonary embolism with no coexisting deep-vein thrombosis) reduces the harms of recurrent thromboembolism and major bleeding compared with 3 months of full anticoagulation at 3, 6 and 12 months. Determine the rate of complications of anticoagulation therapy (predominantly bleeding) in patients with isolated subsegmental pulmonary embolism. Determine whether not treating isolated subsegmental pulmonary embolism is acceptable to clinicians and patients. Determine the reclassification rate of subsegmental pulmonary embolism diagnoses made by general reporting radiologists when reviewed by specialist respiratory radiologists and develop a set of rules to improve general radiologists' diagnoses of subsegmental pulmonary embolism. Assess cost-effectiveness of not treating patients with isolated subsegmental pulmonary embolism with anticoagulation, taking a health service perspective.

Prospective individually randomised open controlled trial with blinded end-point committee assessment for outcomes, powered for non-inferiority for recurrent venous thromboembolism and for superiority for bleeding events. An internal pilot phase is included for feasibility and acceptability of no anticoagulation. We planned to recruit 1466 patients from at least 50 acute hospital sites. Allowing for a dropout rate of 15%, this would have given us 90% power to detect a reduction in major and clinically relevant non-major bleeding from 7.3% in the anticoagulation arm to 3% in the intervention arm. We were powered to determine that a strategy of no anticoagulation was non-inferior to anticoagulation with an upper margin of a 2.3% increase in recurrent venous thromboembolism from an expected rate of 2% in those who receive full anticoagulation. We also planned to undertake a study comparing acute reporting radiologists' diagnoses of subsegmental pulmonary embolism from all computed tomography pulmonary angiograms with specialist respiratory radiologists. This would have allowed us to determine safety in the pilot study (i.e. patients with pulmonary embolism that was in fact larger than subsegmental would have been identified) and develop guidance for subsegmental pulmonary embolism diagnosis for general radiologists. Patients with lived experience of thrombosis contributed to all aspects of the trial design and were part of the Trial Management Group.

The STOPAPE trial was stopped prematurely due to a low recruitment rate in the wake of the COVID pandemic and prioritisation of recovery of the National Institute for Health and Care Research research portfolio. There are no outcome data available for this trial. Separate NIHR Library publications will detail the linked qualitative study examining the views of patients and clinicians around withholding anticoagulation for isolated subsegmental pulmonary embolism as well as presenting all collected data of recruited patients.

This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128073.

 The diagnosis of recurrent ipsilateral deep vein thrombosis (DVT) with compression ultrasonography (CUS) may be hindered by residual intravascular obstruction after previous DVT. A reference CUS, an additional ultrasound performed at anticoagulant discontinuation, may improve the diagnostic work-up of suspected recurrent ipsilateral DVT by providing baseline images for future comparison.

 To evaluate the cost-effectiveness of routinely performing reference CUS in DVT patients.

 Patient-level data (n = 96) from a prospective management study (Theia study; NCT02262052) and claims data were used in a decision analytic model to compare 12 scenarios for diagnostic management of suspected recurrent ipsilateral DVT. Estimated health care costs and mortality due to misdiagnosis, recurrent venous thromboembolism, and bleeding during the first year of follow-up after presentation with suspected recurrence were compared.

 All six scenarios including reference CUS had higher estimated 1-year costs (€1,763-€1,913) than the six without reference CUS (€1,192-€1,474). Costs were higher because reference CUS results often remained unused, as 20% of patients (according to claims data) would return with suspected recurrent DVT. Estimated mortality was comparable in scenarios with (14.8-17.9 per 10,000 patients) and without reference CUS (14.0-18.5 per 10,000). None of the four potentially most desirable scenarios included reference CUS.

 One-year health care costs of diagnostic strategies for suspected recurrent ipsilateral DVT including reference CUS are higher compared to strategies without reference CUS, without mortality benefit. These results can inform policy-makers regarding use of health care resources during follow-up after DVT. From a cost-effectiveness perspective, the findings do not support the routine application of reference CUS.

This review summarizes recent advances in developing targeted diagnostics for venous thromboembolism (VTE) and unaddressed knowledge gaps in patient management. Without addressing these critical data needs, the morbidity in VTE patients will persist.

Recent studies investigating plasma protein profiles in VTE patients have identified key diagnostic targets to address the currently unmet need for low-cost, confirmatory, point-of-care VTE diagnostics. These studies and a growing body of evidence from animal model studies have revealed the importance of inflammatory and vascular pathology in driving VTE, which are currently unaddressed targets for VTE therapy. To enhance the translation of preclinical animal studies, clinical quantification of thrombus burden and comparative component analyses between modeled VTE and clinical VTE are necessary.

Lead candidates from protein profiling of VTE patients' plasma offer a promising outlook in developing low cost, confirmatory, point-of-care testing for VTE. Additionally, addressing the critical knowledge gap of quantitatively measuring clinical thrombi will allow for an array of benefits in VTE management and informing the translatability of experimental therapeutics.

Direct oral anticoagulants (DOAC) are the guideline-recommended therapy for prevention of stroke in atrial fibrillation (AF) and venous thromboembolism. Since approximately 10% of patients using antiepileptic drugs (AED) also receive DOAC, aim of this review is to summarize data about drug-drug interactions (DDI) of DOAC with AED by using data from PubMed until December 2023.

Of 49 AED, only 16 have been investigated regarding DDI with DOAC by case reports or observational studies. No increased risk for stroke was reported only for topiramate, zonisamide, pregabalin, and gabapentin, whereas for the remaining 12 AED conflicting results regarding the risk for stroke and bleeding were found. Further 16 AED have the potential for pharmacodynamic or pharmacokinetic DDI, but no data regarding DOAC are available. For the remaining 17 AED it is unknown if they have DDI with DOAC.

Knowledge about pharmacokinetic and pharmacodynamic DDI of AED and DOAC is limited and frequently restricted to in vitro and in vivo findings. Since no data about DDI with DOAC are available for 67% of AED and an increasing number of patients have a combined medication of DOAC and AED, there is an urgent need for research on this topic.

Direct oral anticoagulants (DOACs) have been shown to be effective and safe in preventing pulmonary embolism recurrence. In this single-center retrospective observational study, we aimed to evaluate the efficacy and safety of reduced-dose DOACs in 86 consecutive patients with acute pulmonary embolism. Patients were divided into standard-dose and reduced-dose DOACs groups. Initial clot volume did not significantly differ between the two groups (standard-dose DOACs vs. reduced-dose DOACs, 18.8 [Q1-Q3 7.3-30.8] mL vs. 10.0 [Q1-Q3 3.2-27.9] mL, p = 0.1). Follow-up computed tomography (CT) within 30 days showed a higher rate of clot volume reduction or disappearance in the standard-dose group compared to the reduced-dose group (standard-dose DOACs vs. reduced-dose DOACs, 81.6% vs. 53.9%, p = 0.02). However, at the final follow-up CT, there was no significant difference in clot volume change between the two groups (standard-dose DOACs vs. reduced-dose DOACs, 91.5% vs. 82.0%, p = 0.19). Major bleeding occurred in two patients in the standard-dose group (4.3%) and three patients in the reduced-dose DOACs group (7.7%) (p = 0.5). In conclusion, while standard-dose DOACs demonstrated superior efficacy in early clot reduction, reduced doses of apixaban and edoxaban showed comparable efficacy and safety profiles in long-term treatment of acute pulmonary embolism in certain patients.

Direct oral anticoagulants (DOACs) are increasingly prescribed for prevention of thromboembolic events. Thus, trauma care providers are facing a steadily raising number of injured patients on DOACs.

Despite a predictable pharmacokinetic profile, the resulting plasma levels of trauma patients upon admission and bleeding risks remain uncertain. Therefore, recent guidelines recommend the measurement of DOAC plasma concentrations in injured patients. Alternatively, DOAC specific visco-elastic tests assays can be applied to identify DOAC patients at bleeding risk.Bleeding complications in trauma patients on DOACs are generally higher compared to nonanticoagulated subjects, but comparable to vitamin K antagonists (VKAs). In particular, a traumatic brain injury does not carry an increased risk of intracranial bleeding due to a DOAK intake compared to VKAs. Current studies demonstrated that up to 14% of patients with a hip fracture are on DOACs prior to surgery. However, the majority can be operated safely within a 24h time window without an increased bleeding rate.Specific antagonists facilitate rapid reversal of patients on DOACs. Idarucizumab for dabigatran, and andexanet alfa for apixaban and rivaroxaban have been approved for life threatening bleeding. Alternatively, prothrombin complex concentrate can be used. Dialysis is a potential treatment option for dabigatran and haemoabsorption with special filters can be applied in patients on FXa-inhibitors.

Current guidelines recommend the measurement of DOAC plasma levels in trauma patients. Compared to VKAs, DOACs do not carry a higher bleeding risk. DOAC specific antagonists facilitate the individual bleeding management.

Anticoagulants are potent therapeutics widely used in medical and surgical settings, and the amount spent on anticoagulation is rising. Although warfarin remains a widely prescribed oral anticoagulant, prescriptions of direct oral anticoagulants (DOACs) have increased rapidly. Heparin-based parenteral anticoagulants include both unfractionated and low molecular weight heparins (LMWHs). In clinical practice, anticoagulants are generally well tolerated, although interindividual variability in response is apparent. This variability in anticoagulant response can lead to serious incident thrombosis, haemorrhage and off-target adverse reactions such as heparin-induced thrombocytopaenia (HIT). This review seeks to highlight the genetic, environmental and clinical factors associated with variability in anticoagulant response, and review the current evidence base for tailoring the drug, dose, and/or monitoring decisions to identified patient subgroups to improve anticoagulant safety. Areas that would benefit from further research are also identified. Validated variants in VKORC1, CYP2C9 and CYP4F2 constitute biomarkers for differential warfarin response and genotype-informed warfarin dosing has been shown to reduce adverse clinical events. Polymorphisms in CES1 appear relevant to dabigatran exposure but the genetic studies focusing on clinical outcomes such as bleeding are sparse. The influence of body weight on LMWH response merits further attention, as does the relationship between anti-Xa levels and clinical outcomes. Ultimately, safe and effective anticoagulation requires both a deeper parsing of factors contributing to variable response, and further prospective studies to determine optimal therapeutic strategies in identified higher risk subgroups.

Patients at extremes of body weight are underrepresented in randomized controlled trials of direct-acting oral anticoagulants (DOACs). Therefore, their optimal anticoagulant treatment remains a topic of debate. The aim of this narrative review is to summarize the evidence on the pharmacokinetic and pharmacodynamic profile of DOACs for treating patients at extremes of body weight in venous thromboembolism (VTE) and in the prevention of cardioembolic stroke in nonvalvular atrial fibrillation (NVAF). A literature search was conducted in the main bibliographic databases, and the most relevant reviews and original articles on the topic were selected. Although data in these patient groups are limited, apixaban and rivaroxaban show a favorable pharmacokinetic and pharmacodynamic profile in obese VTE treatment and NVAF patients and, in the case of apixaban, also in underweight patients. In particular, these drugs demonstrated comparable efficacy and safety to standard therapy. Very few data were available for dabigatran and edoxaban; the latter drug was safer at a lower dose, mainly in underweight patients. Our findings are in line with the last International Society of Haemostasis and Thrombosis position paper and European Heart Rhythm Association 2021 practical guide, suggesting the use of apixaban and rivaroxaban in morbidly obese patients (>120 kg or body mass index ≥40 kg/m 2 ) and the reduced dosage of edoxaban in low-weight patients. Future studies should focus on large populations of patients at extremes of body weights to acquire more clinical and pharmacokinetic evidence on all available DOACs, especially those currently less investigated.

Patients diagnosed with inflammatory bowel disease (IBD), which encompasses Crohn's disease and ulcerative colitis, experience chronic inflammation of the gastrointestinal tract. Those with IBD face a higher risk of developing venous thromboembolism (VTE) compared to individuals without IBD. This escalated risk is associated with various factors, some modifiable and others non-modifiable, with disease activity being the primary concern. Interestingly, Janus Kinase inhibitors approved for the treatment of IBD may be associated with an increased risk of VTE but only in patients that have other underlying risk factors leading to an overall increased VTE risk. Several recognized medical societies have recommended the use of VTE prophylaxis for hospitalized individuals with IBD. The association between VTE and IBD and the need for pharmacologic prophylaxis remains under-recognized. Increased awareness of this complication can hopefully protect patients from a potentially deadly complication.

Venous thromboembolic disease (VTE) is characterized by obstruction of venous blood flow by a thrombus. Survival data, frequency of disease recurrence, and bleeding rate in patients on anticoagulant therapy with warfarin compared to rivaroxaban in the Latin American population are limited in VTE.

A retrospective cohort study with propensity score matching analysis was conducted in patients with pulmonary embolism and/or deep vein thrombosis anticoagulated with warfarin or rivaroxaban treated. Survival analysis was performed using a Kaplan-Meier curve for each of the intervention groups, and it was compared using a Log Rank test.

Of 2193 potentially eligible patients with a suspected diagnosis of VTE, 505 patients entered the analysis; of these, 285 subjects were managed with warfarin and 220 anticoagulated with rivaroxaban. Major bleeding at 12 months occurred in 2.7% (6/220) of patients treated with Rivaroxaban, compared to 10.2% (29/285) in the Warfarin group in the unmatched population (p = 0.001). In the matched population, bleeding at 12 months occurred in 2.9% (6/209) of patients on Rivaroxaban and in 11.0% (23/209) of patients on Warfarin (p = 0.001). The survival rates at 6 months were 97.1% for Rivaroxaban and 97.6% for Warfarin (p = 0.76). At 12 months, the survival rates were 94.7% for Rivaroxaban and 95.7% for Warfarin (p = 0.61).

In the treatment of VTE, there is no differences on 6 and 12-month survival or a reduction in the occurrence of new thromboembolic events when comparing rivaroxaban to warfarin. However, a lower risk of major bleeding is observed at 12 months with Rivaroxaban.