Akerboom B et al. JAMA (July 2026)

Bottom Line: The Hydra study was an open-label, randomized, noninferiority trial conducted from August 22, 2019, to August 21, 2025, involving 698 patients with active cancer and suspected acute pulmonary embolism (PE). Participants were randomly assigned to receive diagnostic management by the YEARS algorithm or CTPA only. The primary outcome was symptomatic venous thromboembolism or (possible) PE-related death within 90 days, with results showing 1.8% in the YEARS group and 5.5% in the CTPA group. The study concluded that the YEARS algorithm is as safe as CTPA, eliminating the need for CTPA in 22% of patients.

LINK TO ARTICLE (Akerboom et al.)

Intermediate dose heparin thromboprophylaxis among critically ill patients with COVID-19

REMAP-CAP Investigators. Journal of Thrombosis and Haemostasis (July 2026)

Bottom Line: This ongoing adaptive platform trial evaluates the effectiveness and safety of intermediate-dose heparin versus standard low-dose thromboprophylaxis in critically ill adults with COVID-19. A total of 1255 patients were enrolled across 78 sites in 15 countries, with interventions lasting up to 14 days. The primary outcome was organ support-free days (OSFDs) through 21 days, showing a 73.5% probability of improvement with intermediate-dose heparin (OR, 1.06; 95% credible interval, 0.87, 1.30). Major bleeding rates were 1.7% in the intervention group and 2.1% in the comparator group. The study concluded that intermediate-dose heparin did not improve OSFDs or survival compared to standard thromboprophylaxis.

LINK TO ARTICLE (REMAP-CAP Inv.)

Rivaroxaban Then Aspirin vs. Aspirin Alone after Total Hip or Knee Arthroplasty

Shivakumar S et al. NEJM (July 2026)

Bottom Line: This multicenter, double-blind, randomized, controlled trial evaluated the effectiveness and safety of aspirin alone versus an initial 5-day course of rivaroxaban followed by aspirin for venous thromboembolism (VTE) prophylaxis after total hip or total knee arthroplasty. A total of 5,429 patients were randomized to receive either aspirin (81 mg daily) or rivaroxaban (10 mg daily) for the first 5 postoperative days, after which all patients received aspirin for the remainder of prophylaxis (9 additional days after knee arthroplasty and 30 additional days after hip arthroplasty). The primary outcome was symptomatic VTE within 90 days. VTE occurred in 0.48% of patients in the aspirin-alone group and 0.45% in the rivaroxaban–aspirin group (risk difference 0.02%; 95% CI, −0.34 to 0.39; P<0.001 for noninferiority). Major or clinically relevant nonmajor bleeding was similar between groups (1.66% vs. 2.04%). The study concluded that aspirin alone was noninferior to an initial short course of rivaroxaban followed by aspirin for preventing symptomatic VTE after hip or knee arthroplasty, with no significant difference in bleeding.

LINK TO ARTICLE (Shivakumar et al.)

Thrombo Trial Files Issue #TBO-2026-05

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Kearon C et al. NEJM (August 2003)

Bottom Line: This randomized, double-blind trial enrolled 738 patients with unprovoked venous thromboembolism who had completed at least 3 months of warfarin therapy and compared continued low-intensity warfarin (target INR 1.5–1.9) with conventional-intensity warfarin (target INR 2.0–3.0). The primary outcome was recurrent venous thromboembolism during a mean follow-up of 2.4 years. Recurrent VTE occurred more frequently in the low-intensity group than in the conventional-intensity group (1.9 vs. 0.7 events per 100 person-years; HR 2.8, 95% CI 1.1–7.0). Rates of major bleeding and overall bleeding were similar between groups. The study demonstrated that conventional-intensity warfarin was more effective than low-intensity warfarin for preventing recurrent VTE without increasing clinically important bleeding.

LINK TO ARTICLE (Kearon et al.)

Long-Term, Low-Intensity Warfarin Therapy for the Prevention of Recurrent Venous Thromboembolism

Ridker PM et al. NEJM (April 2003)

Bottom Line: This randomized, placebo-controlled trial enrolled 508 patients with idiopathic venous thromboembolism who had completed a median of 6.5 months of full-dose anticoagulation and compared long-term low-intensity warfarin (target INR 1.5–2.0) with placebo. The primary outcome was recurrent venous thromboembolism. Over a mean follow-up of 2.1 years, recurrent VTE occurred less frequently in the low-intensity warfarin group than in the placebo group (2.6 vs. 7.2 events per 100 person-years; HR 0.36, 95% CI 0.19–0.67; P<0.001), representing a 64% relative risk reduction. Rates of major bleeding and death were low and did not differ significantly between groups. The study demonstrated that long-term low-intensity warfarin therapy substantially reduced the risk of recurrent VTE compared with placebo.

LINK TO ARTICLE (Ridker et al.)

Low-Dose Aspirin for Preventing Recurrent Venous Thromboembolism

Brighton TA et al. NEJM (November 2012)

Bottom Line: This randomized, placebo-controlled trial enrolled 822 patients who had completed anticoagulation for a first unprovoked venous thromboembolism and compared aspirin 100 mg daily with placebo for up to 4 years. The primary outcome was recurrent venous thromboembolism. Over a median follow-up of 37.2 months, aspirin did not significantly reduce recurrent VTE compared with placebo (4.8% vs. 6.5% per year; HR 0.74, 95% CI 0.52–1.05; P=0.09). However, aspirin significantly reduced the risk of major vascular events, including VTE, myocardial infarction, stroke, or cardiovascular death (HR 0.66, 95% CI 0.48–0.92; P=0.01), without increasing major bleeding. The study suggested that aspirin may provide a modest protective benefit after completion of anticoagulation for unprovoked VTE, particularly for overall vascular outcomes.

LINK TO ARTICLE (Brighton et al.)

Thrombo Trial Files Issue #TBO-2026-04

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Vedantham S et al. NEJM (April 2026)

Bottom Line: This randomized clinical trial evaluated the effectiveness of endovascular therapy (iliac-vein stent placement and enhanced antithrombotic therapy) compared to standard care in 225 patients with moderate or severe post-thrombotic syndrome and iliac-vein obstruction. The primary outcome was the severity of post-thrombotic syndrome measured by the Venous Clinical Severity Score (VCSS) at 6 months, showing a mean VCSS of 8.1 for the intervention group versus 10.0 for the control group (adjusted difference -2.0; P = 0.001). Safety outcomes indicated a higher bleeding risk in the intervention group (11.6% vs. 3.6%; P = 0.03). The study concluded that endovascular therapy improves symptoms and quality of life but increases bleeding risk.

LINK TO ARTICLE (Vedantham et al.)

Bleeding Risk with Apixaban vs. Rivaroxaban in Acute Venous Thromboembolism

Castellucci LA et al. NEJM (March 2026)

Bottom Line: This international, prospective, randomized, open-label, blinded end-point trial assigned 2760 patients with acute symptomatic pulmonary embolism or proximal deep-vein thrombosis to receive either apixaban or rivaroxaban for 3 months. The apixaban group received 10 mg twice daily for 7 days followed by 5 mg twice daily, while the rivaroxaban group received 15 mg twice daily for 21 days followed by 20 mg daily. The primary outcome of clinically relevant bleeding occurred in 3.3% of the apixaban group compared to 7.1% in the rivaroxaban group (relative risk 0.46; P<0.001). Serious adverse events unrelated to bleeding occurred in 2.7% of the apixaban group and 2.2% of the rivaroxaban group, concluding that apixaban significantly reduces bleeding risk compared to rivaroxaban.

LINK TO ARTICLE (Castellucci et al.)

Effects of continuation versus interruption of oral anticoagulation during transcatheter aortic valve implantation on hemostasis function

van Ginkel DJ et al. Journal of Thrombosis and Haemostasis (April 2026)

Bottom Line: This randomized clinical trial evaluated the effects of oral anticoagulation (OAC) continuation versus interruption on hemostasis function in 167 patients undergoing transcatheter aortic valve implantation (TAVI). The study assessed thrombin and plasmin generation, as well as biomarkers related to coagulation and fibrinolysis. Results indicated that OAC continuation led to lower endogenous thrombin potential and plasmin potential, and a reduced increase in fibrin degradation products post-TAVI. However, there was an increased risk of bleeding without apparent differences in thromboembolic risk. The conclusion highlights the modest benefits of OAC continuation during TAVI in reducing coagulation activation.

LINK TO ARTICLE (van Ginkel et al.)

Thrombo Trial Files Issue #TBO-2026-03

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Devereaux PJ et al. NEJM (April 2022)

Bottom Line: This randomized, double-blind, placebo-controlled trial enrolled 9535 patients undergoing noncardiac surgery and assigned them to receive tranexamic acid or placebo. The primary efficacy outcome was a composite bleeding outcome at 30 days, which was significantly lower in the tranexamic acid group than in the placebo group (hazard ratio, 0.76; 95% CI, 0.67 to 0.87). The primary safety outcome was a composite cardiovascular outcome at 30 days, which was not significantly different between the two groups (hazard ratio, 1.02; 95% CI, 0.92 to 1.14). The conclusion was that tranexamic acid decreased the incidence of the composite bleeding outcome, but the noninferiority of tranexamic acid was not established.

LINK TO ARTICLE (Devereaux et al.)

Tranexamic Acid in Patients Undergoing Liver Resection (HeLiX)

Karanicolas PJ et al. JAMA (August 2024)

Bottom Line: This was a multicenter, double-blind, randomized controlled trial evaluating tranexamic acid versus placebo in 1384 patients undergoing liver resection for cancer, conducted at 11 sites in Canada and the United States from 2014 to 2022, with 90-day follow-up. Participants were randomized to receive tranexamic acid (1-g bolus followed by 1-g infusion) or placebo at anesthesia induction. The primary outcome, red blood cell transfusion within 7 days, occurred in 16.3% of the tranexamic acid group versus 14.5% of the placebo group (OR, 1.15; 95% CI, 0.84–1.56; P=0.38). Intraoperative and 7-day blood loss were similar between groups. Tranexamic acid increased complications (OR, 1.28; 95% CI, 1.02–1.60; P=0.03) without significant differences in venous thromboembolism. The study concluded that tranexamic acid does not reduce bleeding or transfusion but increases complications.

LINK TO ARTICLE (Karanicolas et al.)

Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury

Rowell SE et al. JAMA (September 2020)

Bottom Line: This multicenter, double-blind, randomized trial enrolled 1280 patients with moderate or severe traumatic brain injury (TBI) across 20 trauma centers and 39 EMS agencies in the US and Canada. Eligible patients were treated within 2 hours of injury with either tranexamic acid (TXA) or placebo. Three arms were compared: a 1g TXA bolus followed by an 8-hour 1g infusion, a 2g TXA bolus only, or placebo. The primary outcome was favorable neurologic function at 6 months (GOS-E >4). Among 966 analyzed patients, 65% in the TXA group and 62% in the placebo group achieved a favorable outcome (difference, 3.5%; P=0.16), showing no significant benefit. Secondary outcomes including 28-day mortality, progression of intracranial hemorrhage, Disability Rating Scale score, seizures, and thromboembolic events also showed no significant differences. Early out-of-hospital TXA administration did not improve long-term neurologic outcomes in patients with moderate or severe TBI.

LINK TO ARTICLE (Rowell et al.)

Thrombo Trial Files Issue #TBO-2026-02

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Lemesle G et al. NEJM (August 2025)

Bottom Line: This multicenter, double-blind, randomized, placebo-controlled trial conducted in France involved 872 patients with chronic coronary syndrome at high atherothrombotic risk receiving long-term oral anticoagulation. Participants were assigned to receive either aspirin (100 mg once daily) or placebo. The primary outcome was a composite of cardiovascular events, which occurred in 16.9% of the aspirin group compared to 12.1% in the placebo group (P = 0.02). Major bleeding occurred in 10.2% of the aspirin group versus 3.4% in the placebo group (P < 0.001). The study concluded that adding aspirin increased the risk of cardiovascular events and major bleeding.

LINK TO ARTICLE (Lemesle et al.)

Short-Term Anticoagulation Versus Dual Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure (ANDES)

Rodés-Cabau J et al. Circulation (October 2025)

Bottom Line: This prospective multicenter international randomized trial evaluated two antithrombotic strategies for preventing device-related thrombosis (DRT) following transcatheter left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation. A total of 510 patients were randomized to receive either direct oral anticoagulants (DOAC) or dual antiplatelet therapy (DAPT, aspirin + clopidogrel) for 60 days. The primary outcome, DRT at 60 days, occurred in 1.5% of the DOAC group and 4.1% of the DAPT group (difference -2.7% [95% CI, -6.0% to 0.6%], p=0.110). The safety outcome showed a lower rate of complications in the DOAC group. Overall, DOAC was associated with an improved safety profile despite not reducing DRT.

LINK TO ARTICLE (Rodés-Cabau et al.)

Randomized Controlled Trial of Mechanical Thrombectomy With Anticoagulation Versus Anticoagulation Alone for Acute Intermediate-High Risk Pulmonary Embolism (STORM-PE)

Lookstein RA et al. Circulation (November 2025)

Bottom Line: The STORM-PE trial is a randomized controlled trial evaluating the efficacy and safety of computer-assisted vacuum thrombectomy (CAVT) with anticoagulation versus anticoagulation alone in adults with intermediate-high risk pulmonary embolism. A total of 100 patients were enrolled and randomized to either CAVT (N=47) or anticoagulation alone (N=53). The primary outcome, change in RV/LV ratio at 48 hours, showed a mean reduction of 0.52 ± 0.37 in the CAVT group compared to 0.24 ± 0.40 in the control group (difference 0.27, 95% CI, 0.12, 0.43; P<0.001). Safety outcomes indicated comparable major adverse event rates between the two groups. The study concluded that CAVT is superior to anticoagulation alone in reducing RV/LV ratio and normalizing vital signs.

LINK TO ARTICLE (Lookstein et al.)

Thrombo Trial Files Issue #TBO-2026-01

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Ades S et al. Journal of Thrombosis and Haemostasis (June 2018)

Bottom Line: This was a double‑blind, crossover RCT evaluating whether rosuvastatin reduces biomarkers of VTE risk in patients with advanced cancer receiving systemic therapy. Thirty‑eight patients were randomized to rosuvastatin 20 mg daily or placebo for 3–4 weeks, crossed over after a washout, and underwent biomarker testing at the start and end of each phase. Rosuvastatin did not significantly change D‑dimer or other coagulation markers, although CRP fell by 40%. Post‑hoc analysis suggested a small D‑dimer reduction when rosuvastatin was given first‑line. Detection of TF, FIXa, and FXIa was common in cancer patients but absent in controls. The study concluded that rosuvastatin did not meaningfully modify VTE‑associated biomarkers, leaving the role of statins for thromboprophylaxis in cancer uncertain.

LINK TO ARTICLE (Ades et al.)

Electronic alert system for improving appropriate thromboprophylaxis in hospitalized medical patients

Spirk D et al. Journal of Thrombosis and Haemostasis (August 2017)

Bottom Line: This was a randomized trial of 1,593 internal medicine inpatients comparing a Geneva‑Risk‑Score‑based electronic alert system versus usual care to improve thromboprophylaxis use. Appropriate prophylaxis occurred in 66.7% of both alert and control groups, showing no benefit of the intervention. More than half of alert‑assigned patients had no score calculated or had an incorrect score, and appropriate prophylaxis was more common when the score was completed accurately. The study concluded that the e‑alert did not increase thromboprophylaxis rates, likely due to low physician uptake, and baseline prophylaxis rates were higher than expected.

LINK TO ARTICLE (Spirk et al.)

Influence of thrombophilia on risk of recurrent venous thromboembolism while on warfarin

Kearon C et al. Blood (December 2008)

Bottom Line: This was a randomized controlled trial evaluating whether thrombophilic defects increase the risk of recurrent venous thromboembolism (VTE) in 661 patients with unprovoked VTE receiving extended low-intensity (INR 1.5–1.9) or conventional-intensity (INR 2.0–3.0) warfarin. Over a mean follow-up of 2.3 years, 42% had ≥1 thrombophilic defect. The overall recurrence rate was 0.9% per patient-year. Presence of thrombophilic markers, including factor V Leiden, prothrombin gene mutation, antithrombin deficiency, elevated factor VIII or XI, and hyperhomocysteinemia, was not associated with increased recurrence. Only antiphospholipid antibodies showed a nonsignificant trend toward increased risk. The study concluded that thrombophilic defects do not predict recurrent VTE during warfarin therapy.

LINK TO ARTICLE (Kearon et al.)

Thrombo Trial Files Issue #TBO-2025-13

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Zhang Z et al. Journal of Thrombosis and Haemostasis (November 2025)

Bottom Line: This randomized clinical trial assessed the effectiveness of limb intermittent compression devices (ICD) combined with subcutaneous low-molecular-weight heparin (LMWH) versus LMWH alone for venous thromboembolism (VTE) prophylaxis in 283 patients undergoing elective lengthy neurosurgical procedures. The primary outcomes included VTE incidence evaluated through clinical symptoms and systematic screening, with results showing 2.5% and 0% for the intervention group, and 3.1% and 1.0% for the control group, respectively. The relative risk for VTE in the ICD + LMWH group was 0.7 (95% CI, 0.2-3.3). The study concluded that the addition of ICD to LMWH does not significantly reduce VTE events in this patient population.

LINK TO ARTICLE (Zhang et al.)

Systematic Ultrasound Screening for Lower Extremity Deep Vein Thrombosis in ICU Patients with Severe COVID-19

Marrero Eligio De La Puente CE et al. Journal of Intensive Care Medicine (January 2025)

Bottom Line: This was a single-center, randomized controlled trial conducted in ICU patients with severe COVID-19, evaluating the impact of systematic ultrasound (US) screening for deep vein thrombosis (DVT) versus usual care. A total of 163 patients were randomized to the screening group (n = 84), which received twice-weekly DVT ultrasounds, or the control group (n = 79), which followed standard protocol. The primary outcome, DVT detection, was significantly higher in the screening group (16.7%) compared to control (3.8%; p = 0.007), while rates of pulmonary embolism and mortality did not differ significantly. The composite poor prognosis outcome also showed no significant difference between groups (p = 0.123). No major safety concerns were reported. The study concluded that systematic DVT screening increased detection but did not improve clinical outcomes in critically ill COVID-19 patients.

LINK TO ARTICLE (De La Puente et al.)

Apixaban versus no anticoagulation for the prevention of venous thromboembolism in children with newly diagnosed acute lymphoblastic leukaemia or lymphoma (PREVAPIX-ALL)

O’Brien S et al. The Lancet Haematology (January 2024)

Bottom Line: This was a phase 3, open-label, randomized controlled trial (PREVAPIX-ALL) evaluating apixaban versus no anticoagulation for thromboprophylaxis in 512 pediatric patients (aged 1 to <18 years) with newly diagnosed acute lymphoblastic leukemia or lymphoma and a central venous line. Patients were randomized 1:1 to receive weight-adjusted apixaban (n = 256) or standard of care (n = 256) during induction chemotherapy, with a median follow-up of 27 days. The primary efficacy outcome, composite of symptomatic or asymptomatic venous thromboembolism, occurred in 12% of apixaban-treated patients versus 18% in the control group (RR 0.69; 95% CI, 0.45–1.05; p=0.080). Major bleeding occurred in 2 patients in each group, while clinically relevant non-major bleeding (mainly epistaxis) was more common with apixaban (4% vs. 1%; p=0.030). The study concluded that apixaban did not significantly reduce VTE, but was generally well tolerated and may be considered in high-risk patients.

LINK TO ARTICLE (O'Brien et al.)

Thrombo Trial Files Issue #TBO-2025-12

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Gage BF et al. JAMA (September 2019)

Bottom Line: This was a multicenter, open-label, randomized controlled trial (GIFT) conducted from 2011 to 2016 in 1650 patients aged ≥65 undergoing elective hip or knee arthroplasty, comparing warfarin prophylaxis with a target INR of 1.8 (n = 823) versus 2.5 (n = 827). The primary outcome was a composite of venous thromboembolism (VTE) within 60 days or death within 30 days. The event rate was 5.1% in the low-INR group and 3.8% in the standard-INR group (difference, 1.3%; 1-sided 95% CI, −∞ to 3.05%; P=0.06), narrowly missing the prespecified noninferiority margin. Major bleeding occurred in 0.4% versus 0.9% of patients, respectively. INR values ≥4 were significantly more common in the standard-INR group (12.2% vs. 4.5%). The study concluded that a target INR of 1.8 did not meet noninferiority for prevention of VTE or death but had fewer supratherapeutic INR readings and bleeding events.

LINK TO ARTICLE (Gage et al.)

Dose-adjusted enoxaparin thromboprophylaxis in hospitalized cancer patients

Zwicker JI et al. Blood Advances (May 2020)

Bottom Line: This was a phase 2, randomized, double-blind trial evaluating fixed-dose versus weight-adjusted low-molecular-weight heparin (enoxaparin) in 50 hospitalized patients with active cancer at high risk for venous thromboembolism (VTE) based on the Padua score. Patients were randomized to receive fixed-dose enoxaparin (40 mg daily) or weight-adjusted enoxaparin (1 mg/kg daily) during hospitalization. The primary outcomes were safety of the weight-adjusted regimen and incidence of VTE with fixed dosing. No major bleeding or symptomatic VTE occurred in either arm; one incidental pulmonary embolism was detected in the weight-adjusted group. Among fixed-dose recipients who underwent surveillance ultrasound, the cumulative incidence of asymptomatic deep vein thrombosis was 22% (90% CI, 0–51.3%). The study concluded that weight-adjusted enoxaparin is feasible and well-tolerated, and highlighted a high rate of asymptomatic VTE in this population.

LINK TO ARTICLE (Zwicker et al.)

Rosuvastatin use reduces thrombin generation potential in patients with venous thromboembolism

Orsi FA et al. Journal of Thrombosis and Haemostasis (February 2019)

Bottom Line: This was a randomized, open-label, controlled phase 2 trial (START) evaluating the effect of rosuvastatin on thrombin generation in 245 patients with prior venous thromboembolism (VTE) following anticoagulation cessation. Patients were randomized to receive rosuvastatin 20 mg daily (n = 126) or no intervention (n = 119) for 4 weeks. The primary outcome was change in thrombin generation, assessed via endogenous thrombin potential (ETP) and thrombin peak. ETP increased in the control group (+97.22 nmmin) and decreased in the rosuvastatin group (–24.94 nmmin), with a between-group difference of –120.24 nm*min (95% CI, –192.97 to –47.51). Thrombin peak increased in both groups but less so with rosuvastatin. No bleeding or safety outcomes were reported. The study concluded that rosuvastatin reduces thrombin generation potential in patients with prior VTE, particularly those with cardiovascular risk factors or unprovoked VTE.

LINK TO ARTICLE (Orsi et al.)

Thrombo Trial Files Issue #TBO-2025-11

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Piazza G et al. NEJM (August 2025)

Bottom Line: This was a single-center, double-blind, randomized controlled trial evaluating extended low-dose apixaban (2.5 mg twice daily) versus placebo in 600 adults with venous thromboembolism (VTE) provoked by transient factors but with at least one enduring risk factor, following at least 3 months of initial anticoagulation. Participants were randomized to apixaban (n = 300) or placebo (n = 300) for 12 months. The primary outcome, symptomatic recurrent VTE, occurred in 1.3% of the apixaban group versus 10.0% in the placebo group (HR, 0.13; 95% CI, 0.04–0.36; P<0.001). Major bleeding occurred in 1 patient on apixaban and none on placebo. Clinically relevant nonmajor bleeding occurred more frequently in the apixaban group (4.8% vs. 1.7%; P=0.06). The study concluded that extended low-dose apixaban significantly reduced recurrent VTE with a low risk of major bleeding.

LINK TO ARTICLE (Piazza et al.)

Perioperative management of direct oral anticoagulants in patients having a high-bleed-risk surgery or neuraxial procedure (PAUSE)-2

Douketis JD et al. Journal of Thrombosis and Haemostasis (July 2025)

Bottom Line: The PAUSE-2 pilot trial was an open-label, randomized controlled trial assessing the feasibility of perioperative management strategies for patients on direct oral anticoagulants (DOACs) undergoing elective high-bleed-risk surgery. A total of 159 patients with atrial fibrillation were enrolled, with 141 undergoing preoperative DOAC-level testing. The primary outcome was the measurement of residual DOAC levels, which were found to be 19 ng/mL in the ASRA group and 20 ng/mL in the PAUSE group. The study concluded that both management strategies yielded similar preoperative DOAC levels, supporting the feasibility of a larger trial.

LINK TO ARTICLE (Douketis et al.)

Rivaroxaban for 18 Months Versus 6 Months in Patients With Cancer and Acute Low-Risk Pulmonary Embolism (ONCO PE)

Yamashita Y et al. Circulation (November 2024)

Bottom Line: This was a multicenter, open-label, adjudicator-blinded, randomized controlled trial conducted at 32 institutions in Japan from 2021 to 2023, evaluating rivaroxaban duration in 178 patients with cancer and acute low-risk pulmonary embolism. Patients were randomized to receive rivaroxaban for either 18 months (n = 89) or 6 months (n = 89). The primary outcome, recurrent venous thromboembolism (VTE) at 18 months, occurred in 5.6% of the 18-month group versus 19.1% of the 6-month group (OR, 0.25; 95% CI, 0.09–0.72; P=0.01). Major bleeding occurred in 7.8% and 5.6% of patients, respectively (OR, 1.43; 95% CI, 0.44–4.70; P=0.55). The study concluded that 18-month rivaroxaban therapy was superior to 6-month treatment in reducing VTE recurrence without a significant increase in major bleeding.

LINK TO ARTICLE (Yamashita et al.)

Thrombo Trial Files Issue #TBO-2025-10

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Pokorney SD et al. Circulation (November 2022)

Bottom Line: The RENAL-AF trial was a prospective, randomized, open-label, blinded-outcome evaluation (PROBE) that compared the safety and efficacy of apixaban and warfarin in patients with end-stage kidney disease on hemodialysis and with atrial fibrillation (AF). A total of 154 patients were randomly assigned to receive either apixaban or warfarin. The primary outcome was time to major or clinically relevant nonmajor bleeding, with secondary outcomes including stroke, mortality, and apixaban pharmacokinetics. The trial was stopped prematurely due to enrollment challenges, and there was no significant difference in rates of major or clinically relevant nonmajor bleeding between the two groups. However, death was the most common major event in both groups, highlighting the need for future studies to evaluate the risks versus benefits of anticoagulation in this patient population.

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LINK TO ARTICLE (Pokorney et al.)

Apixaban compared with warfarin to prevent thrombosis in thrombotic antiphospholipid syndrome

Woller SC et al. Blood Advances (March 2022)

Bottom Line: This was a multicenter, prospective, randomized, open-label, blinded endpoint study that compared the efficacy and safety of apixaban and warfarin in patients with thrombotic antiphospholipid syndrome (TAPS). The study was conducted for 12 months and included 48 patients who were assigned to either apixaban or warfarin. The primary outcome was clinically overt thrombosis and vascular death, which was evaluated by independent experts blinded to treatment allocation. The results showed that apixaban may not be routinely substituted for warfarin in preventing recurrent thrombosis, especially strokes, in TAPS patients. However, the study was limited by protocol modifications and low patient accrual.

LINK TO ARTICLE (Woller et al.)

Apixaban and dalteparin in active malignancy‐associated venous thromboembolism (ADAM VTE)

McBane II RD et al. Journal of Thrombosis and Haemostasis (February 2020)

Bottom Line: This randomized controlled trial compared the use of apixaban and dalteparin in patients with cancer-associated VTE. 300 patients were included in the study, with 66% having metastatic disease and 74% receiving concurrent chemotherapy. The primary outcome was major bleeding, which occurred in 0% of patients receiving apixaban and 1.4% of patients receiving dalteparin. Recurrent VTE occurred in 0.7% of apixaban patients and 6.3% of dalteparin patients. The overall rates of major bleeding or clinically relevant non-major bleeding were 6% for both groups. The study concluded that oral apixaban is a safe and effective treatment for VTE in cancer patients.

LINK TO ARTICLE (McBane II et al.)

Thrombo Trial Files Issue #TBO-2025-09

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Gao C et al. BMJ (March 2025)

Bottom Line: This multicentre, randomised, open-label, assessor-blind, non-inferiority trial (REC-CAGEFREE II) was conducted across 41 hospitals in China from November 27, 2021, to January 21, 2023. It involved 1948 adults with acute coronary syndrome treated with paclitaxel-coated balloons. Participants were assigned to either a stepwise dual antiplatelet therapy (DAPT) de-escalation group or a standard DAPT group. The primary outcome, net adverse clinical events at 12 months, was 8.9% in the intervention group and 8.6% in the comparator group, with a non-inferiority result of difference 0.36% (upper CI 2.47%, P=0.013). Safety outcomes showed lower BARC type 3 or 5 bleeding in the intervention group.

LINK TO ARTICLE (Gao et al.)

Low-dose aspirin versus placebo in postpartum venous thromboembolism

Skeith L et al. The Lancet Haematology (February 2025)

Bottom Line: The pilot PARTUM trial was a multi-national, randomised, double-blind, placebo-controlled trial conducted in seven centres across Canada, France, Ireland, and the Netherlands. It aimed to assess the feasibility of conducting a postpartum thromboprophylaxis trial in individuals with venous thromboembolism risk factors. 808 participants were enrolled and randomly assigned to receive either aspirin 81 mg or placebo for 42 days. The primary outcome was the mean recruitment rate, which was 6.3 patients per site per month. No venous thromboembolism events occurred in the intervention group, and one participant had distal deep vein thrombosis in the control group. No major bleeds occurred, but 3 participants in the intervention group had clinically relevant non-major bleeds. The study concluded that a global postpartum thromboprophylaxis trial is needed to provide high-quality data.

LINK TO ARTICLE (Skeith et al.)

Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion

Goyal M et al. NEJM (February 2025)

Bottom Line: This multicenter, prospective, randomized, open-label trial with blinded outcome evaluation enrolled 530 patients with acute ischemic stroke due to medium-vessel occlusion from April 2022 to June 2024. Participants were assigned to receive EVT plus usual care or usual care alone. The primary outcome was the modified Rankin scale score at 90 days, with 41.6% in the EVT group achieving scores of 0 or 1 compared to 43.1% in the usual care group. Safety outcomes included a mortality rate of 13.3% in the EVT group and symptomatic intracranial hemorrhage in 5.4% of patients. The study concluded that EVT did not improve outcomes compared to usual care.

LINK TO ARTICLE (Goyal et al.)

Thrombo Trial Files Issue #TBO-2025-08

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INSPIRATION Investigators. JAMA (March 2021)

Bottom Line: This is a multicenter randomized trial with a 2x2 factorial design comparing intermediate-dose vs standard-dose prophylactic anticoagulation and statin therapy vs placebo in adult patients with COVID-19 admitted to the ICU. The study did not report results for the second hypothesis. The primary outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days. The study found no significant difference in the primary outcome between the intervention and control groups. However, major bleeding occurred in 2.5% of the intermediate-dose group and severe thrombocytopenia occurred in 2.2% of the intermediate-dose group. The study does not support the routine use of intermediate-dose prophylactic anticoagulation in unselected patients with COVID-19 admitted to the ICU.

LINK TO ARTICLE (INSPIRATION)

Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (CaVenT)

Enden T et al. The Lancet (January 2012)

Bottom Line: This open-label, randomized controlled trial aimed to examine the effectiveness of additional treatment with catheter-directed thrombolysis (CDT) using alteplase in reducing the development of post-thrombotic syndrome (PTS) in patients with a first-time iliofemoral deep vein thrombosis (DVT). A total of 209 patients aged 18-75 years were randomly assigned to receive either conventional treatment alone or additional CDT. The primary outcomes were the frequency of PTS at 24 months and iliofemoral patency after 6 months. The results showed that patients in the CDT group had a lower frequency of PTS and higher iliofemoral patency compared to those in the control group. However, there were 20 bleeding complications related to CDT. The conclusion is that additional CDT should be considered in patients with a high proximal DVT and low risk of bleeding.

LINK TO ARTICLE (Enden et al.)

DVT Prophylaxis After TKA: Routine Anticoagulation Vs Risk Screening Approach

Kulshrestha V et al. The Journal of Arthroplasty (December 2013)

Bottom Line: This was a randomized study comparing routine anticoagulation versus risk stratification with selective anticoagulation for DVT prophylaxis after total knee arthroplasty (TKA). A total of 673 patients were included and randomized after DVT risk screening. The primary outcome was symptomatic DVT and wound complications. Results showed no significant difference in symptomatic DVT rates between the two groups, but a higher incidence of wound complications with routine anticoagulation. The study duration and blinding were not mentioned. The patient population consisted of patients undergoing TKA. The intervention group received routine anticoagulation with dosages based on risk screening, while the comparator group received risk stratification with selective anticoagulation. The sample size was 673 patients. The conclusion was that routine anticoagulation and risk stratification with selective anticoagulation have similar rates of symptomatic DVT after TKA, but routine anticoagulation may lead to higher incidence of wound complications.

LINK TO ARTICLE (Kulshrestha et al.)

Thrombo Trial Files Issue #TBO-2025-07

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Couturaud F et al. The Lancet (March 2025)

Bottom Line: The RENOVE trial was a non-inferiority, multicenter, randomized, open-label study conducted in France from November 2017 to July 2022, involving 2768 ambulatory patients aged 18 or older with acute symptomatic venous thromboembolism. Participants were assigned to receive either reduced-dose direct oral anticoagulants (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily) or full-dose (apixaban 5 mg twice daily or rivaroxaban 20 mg once daily). The primary outcome was symptomatic recurrent venous thromboembolism, with results showing a 5-year cumulative incidence of 2.2% in the reduced-dose group and 1.8% in the full-dose group. The study concluded that while the reduced dose did not meet non-inferiority criteria, it may be considered due to lower bleeding rates.

LINK TO ARTICLE (Couturaud et al.)

Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery (FARES-II)

Karkouti K et al. JAMA (March 2025)

Bottom Line: This unblinded randomized noninferiority clinical trial, conducted across 12 hospitals in Canada and the US from November 30, 2022, to May 28, 2024, evaluated the efficacy and safety of 4-factor prothrombin complex concentrate (PCC) versus frozen plasma in adults with coagulopathic bleeding during cardiac surgery. A total of 538 patients were enrolled, with 420 included in the primary analysis. The primary outcome of hemostatic response showed PCC had a higher effectiveness (77.9% vs 60.4%) and fewer transfusions (mean 6.6 units vs 9.3 units). PCC also demonstrated safety advantages, with fewer serious adverse events and acute kidney injuries compared to frozen plasma.

LINK TO ARTICLE (Karkouti et al.)

Alteplase for Posterior Circulation Ischemic Stroke at 4.5 to 24 Hours

Yan S et al. NEJM (April 2025)

Bottom Line: This randomized clinical trial evaluated the effects of intravenous alteplase versus standard medical treatment in 234 patients with posterior circulation ischemic stroke, conducted in China. The study assessed functional independence at 90 days as the primary outcome and found that 89.6% of the alteplase group achieved this compared to 72.6% in the comparator group (adjusted risk ratio 1.16; 95% CI, 1.03 to 1.30; P = 0.01). Safety outcomes included symptomatic intracranial hemorrhage (1.7% vs. 0.9%) and mortality (5.2% vs. 8.5%). The findings suggest that alteplase improves functional independence in this patient population.

LINK TO ARTICLE (Yan et al.)

Thrombo Trial Files Issue #TBO-2025-06

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Wells PS et al. NEJM (September 2003)

Bottom Line: This randomized trial compared different diagnostic strategies for suspected deep-vein thrombosis in outpatients. The study included 1096 patients and found that the use of D-dimer testing, followed by ultrasound imaging if necessary, was safe and resulted in a significant reduction in the use of ultrasound. The primary outcome of deep-vein thrombosis or pulmonary embolism at 3 months was 0.4% in the D-dimer group and 1.4% in the control group, with no significant difference between the two groups. The study concluded that D-dimer testing can safely rule out deep-vein thrombosis in patients who are clinically unlikely to have the condition. No significant safety concerns were reported.

LINK TO ARTICLE (Wells et al.)

Rivaroxaban Versus Vitamin K Antagonist in Antiphospholipid Syndrome

Ordi-Ros J et al. Annals of Internal Medicine (October 2019)

Bottom Line: This 3-year, open-label, randomized noninferiority trial aimed to determine whether rivaroxaban is noninferior to dose-adjusted vitamin K antagonists (VKAs) for thrombotic antiphospholipid antibody syndrome (APS). The study included 190 adults aged 18 to 75 years with thrombotic APS and compared rivaroxaban (20 mg/d or 15 mg/d) to dose-adjusted VKAs. The primary outcome was the proportion of patients with new thrombotic events after 3 years of follow-up. The results showed that rivaroxaban did not show noninferiority to VKAs and had a non-statistically significant near doubling of the risk for recurrent thrombosis. Safety outcomes showed similar rates of major bleeding in both groups.

LINK TO ARTICLE (Ordi-Ros et al.)

Apixaban and Valve Thrombosis After Transcatheter Aortic Valve Replacement: The ATLANTIS-4D-CT Randomized Clinical Trial Substudy

Montalescot G et al. JACC Cardiovascular Interventions (September 2022)

Bottom Line: The ATLANTIS trial was a randomized study that compared apixaban 5 mg twice daily to standard of care (vitamin K antagonists or antiplatelet therapy) in patients who underwent TAVR without an established indication for anticoagulation. The study included 762 participants and the primary outcome was subclinical obstructive valve thrombosis at 90 days. Results showed that apixaban was associated with a reduced risk of subclinical obstructive valve thrombosis compared to antiplatelet therapy, but not compared to vitamin K antagonists. Safety outcomes were similar between the two groups, with more noncardiovascular deaths in the apixaban group.

LINK TO ARTICLE (Montalescot et al.)

Thrombo Trial Files Issue #TBO-2025-05

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Huang J et al. JAMA (January 2025)

Bottom Line: This randomized, open-label, blinded outcome assessment trial evaluated the efficacy and adverse events of adjunctive intra-arterial tenecteplase in patients with large vessel occlusion stroke who had achieved near-complete to complete reperfusion after endovascular thrombectomy (EVT). A total of 540 patients were enrolled and randomly assigned to receive intra-arterial tenecteplase or no intra-arterial thrombolysis. The primary efficacy outcome was freedom from disability at 90 days, with a primary safety outcome of death at 90 days and symptomatic intracranial hemorrhage within 48 hours. Results showed no significant difference in the likelihood of freedom from disability at 90 days between the intervention and control groups. The trial was completed with a high completion rate of 99.8%. In conclusion, adjunctive intra-arterial tenecteplase did not significantly increase the likelihood of freedom from disability at 90 days in patients with acute ischemic stroke due to large vessel occlusion who had achieved near-complete to complete reperfusion after EVT.

LINK TO ARTICLE (Huang et al.)

Continuation versus Interruption of Oral Anticoagulation during TAVI

van Ginkel DJ et al. NEJM (August 2024)

Bottom Line: This international, open-label, randomized, noninferiority trial compared periprocedural continuation vs. interruption of oral anticoagulation in patients undergoing transcatheter aortic-valve implantation (TAVI) with a concomitant indication for oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI. Results showed no significant difference between the two groups, with a primary outcome event rate of 16.5% in the continuation group and 14.8% in the interruption group. Thromboembolic events occurred in 8.8% and 8.2%, while bleeding occurred in 31.1% and 21.3%, respectively. This study suggests that periprocedural continuation of oral anticoagulation may not be noninferior to interruption in this patient population.

LINK TO ARTICLE (van Ginkel et al.)

Efficacy and safety of nerinetide in acute ischaemic stroke in patients undergoing endovascular thrombectomy without previous thrombolysis (ESCAPE-NEXT)

Hill MD et al. The Lancet (February 2025)

Bottom Line: The ESCAPE-NA1 trial was a multicentre, randomized, double-blind, placebo-controlled study that aimed to confirm the clinical benefit of nerinetide, an eicosapeptide, in patients with acute ischaemic stroke due to large vessel occlusion. The study included 850 patients and found that treatment with nerinetide did not result in a significant improvement in functional outcome at 90 days compared to placebo. However, there were no excess adverse events in the intervention group. Further research is needed to determine the ideal timing of treatment and which sub-populations of stroke patients may benefit from nerinetide in combination with current reperfusion therapies.

LINK TO ARTICLE (Hill et al.)

Thrombo Trial Files Issue #TBO-2025-04

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Ordi-Ros J et al. Annals of Internal Medicine (October 2019)

Bottom Line: This 3-year, open-label, randomized noninferiority trial aimed to determine whether rivaroxaban is noninferior to dose-adjusted vitamin K antagonists (VKAs) for thrombotic antiphospholipid antibody syndrome (APS). The study included 190 adults aged 18 to 75 years with thrombotic APS and compared rivaroxaban (20 mg/d or 15 mg/d) to dose-adjusted VKAs. The primary outcome was the proportion of patients with new thrombotic events after 3 years of follow-up. The results showed that rivaroxaban did not show noninferiority to VKAs and had a non-statistically significant near doubling of the risk for recurrent thrombosis. Safety outcomes showed similar rates of major bleeding in both groups.

LINK TO ARTICLE (Ordi-Ros et al.)

Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2)

CRASH-2 Trial Collaborators. The Lancet (July 2010)

Bottom Line: This is a randomised controlled trial in 20211 adult trauma patients with, or at risk of, significant bleeding, conducted in 274 hospitals in 40 countries. Patients were randomly assigned to receive either tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or placebo within 8 h of injury. Both participants and study staff were masked to treatment allocation. The primary outcome was death in hospital within 4 weeks of injury, with a significant reduction in the tranexamic acid group (14.5%) compared to the placebo group (16.0%). Tranexamic acid also significantly reduced the risk of death due to bleeding.

LINK TO ARTICLE (CRASH-2)

Apixaban vs. warfarin in patients with left ventricular thrombus

Alcalai R et al. European Heart Journal Cardiovascular Pharmacotherapy (July 2021)

Bottom Line: This was a prospective, randomized, multicentre open-label clinical trial comparing the efficacy of apixaban and warfarin in treating LV thrombus after acute MI. The study included 35 patients and the primary outcome was the presence and size of LV thrombus 3 months after initiation of anticoagulation. Results showed that apixaban was non-inferior to warfarin, with 16 patients in the apixaban group and 14 patients in the warfarin group having complete resolution of thrombus. No major bleeding events were recorded in the apixaban group, while two patients had major bleeding in the warfarin group. One stroke and one death occurred in the warfarin and apixaban groups, respectively. Overall, apixaban is a safe and effective alternative to warfarin for treating LV thrombus after acute MI.

LINK TO ARTICLE (Alcalai et al.)

Thrombo Trial Files Issue #TBO-2025-03

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Piccini JP et al. NEJM (September 2024)

Bottom Line: This phase 3, international, double-blind trial included 14,810 high-risk patients with atrial fibrillation who were randomly assigned to receive either asundexian at a dose of 50 mg once daily or standard-dose apixaban. The primary efficacy objective was to determine if asundexian was noninferior to apixaban for the prevention of stroke or systemic embolism, while the primary safety objective was to determine if asundexian was superior to apixaban in terms of major bleeding events. The trial was stopped prematurely due to the recommendation of the independent data monitoring committee. Results showed that asundexian had a higher incidence of stroke or systemic embolism compared to apixaban, but with fewer major bleeding events.

LINK TO ARTICLE (Piccini et al.)

Tranexamic Acid in Patients Undergoing Liver Resection (HeLiX)

Karanicolas PJ et al. JAMA (August 2024)

Bottom Line: This was a multicenter, double-blind, randomized controlled trial evaluating tranexamic acid versus placebo in 1384 patients undergoing liver resection for cancer, conducted at 11 sites in Canada and the United States from 2014 to 2022, with 90-day follow-up. Participants were randomized to receive tranexamic acid (1-g bolus followed by 1-g infusion) or placebo at anesthesia induction. The primary outcome, red blood cell transfusion within 7 days, occurred in 16.3% of the tranexamic acid group versus 14.5% of the placebo group (OR, 1.15; 95% CI, 0.84–1.56; P=0.38). Intraoperative and 7-day blood loss were similar between groups. Tranexamic acid increased complications (OR, 1.28; 95% CI, 1.02–1.60; P=0.03) without significant differences in venous thromboembolism. The study concluded that tranexamic acid does not reduce bleeding or transfusion but increases complications.

LINK TO ARTICLE (Karanicolas et al.)

Rivaroxaban versus low molecular weight heparin for managing lower extremity deep vein thrombosis following thoracoscopic lung cancer surgery

Zhang L et al. BMJ (January 2025)

Bottom Line: This was a randomized controlled trial evaluating the effectiveness and safety of rivaroxaban versus low molecular weight heparin (LMWH) in 60 patients with lower extremity deep vein thrombosis (DVT) after thoracoscopic lung cancer surgery. Patients were randomized to rivaroxaban or LMWH and followed for three months. Both groups showed stable D-dimer levels and no new thrombus formation on vascular ultrasound. Postoperative complications such as pleural effusion or bleeding were absent, though subcutaneous bruising occurred in 6 LMWH-treated patients. The study concluded that rivaroxaban is as effective as LMWH for managing postoperative DVT and has a superior safety profile.

LINK TO ARTICLE (Zhang et al.)

Thrombo Trial Files Issue #TBO-2025-02

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Simonneau G et al. NEJM (September 1997)

Bottom Line: This randomized controlled trial compared the use of subcutaneous low-molecular-weight heparin (tinzaparin) given once daily in a fixed dose to adjusted-dose, intravenous unfractionated heparin in 612 patients with symptomatic pulmonary embolism. The primary outcome, a combined end point of recurrent thromboembolism, major bleeding, and death, was evaluated at day 8 and day 90. The results showed no statistically significant difference between the two treatment groups. The risk of major bleeding was also similar in both groups. This study suggests that initial subcutaneous therapy with tinzaparin may be as effective and safe as intravenous unfractionated heparin in patients with acute pulmonary embolism.

LINK TO ARTICLE (Simonneau et al.)

Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients With Cerebral Venous Thrombosis

Ferro JM et al. JAMA Neurology (September 2019)

Bottom Line: This was an exploratory, prospective, randomized, parallel-group, open-label, multicenter clinical trial with blinded end-point adjudication. It compared the efficacy and safety of dabigatran etexilate with dose-adjusted warfarin in preventing recurrent VTEs in 120 adult patients with acute CVT. The primary outcome was a composite of new VTE or major bleeding during a 24-week treatment period. The results showed no significant difference in risk of recurrent VTEs or bleeding between the two groups. Both medications were found to be safe and effective for preventing recurrent VTEs in patients with CVT.

LINK TO ARTICLE (Ferro et al.)

Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism

Raskob GE et al. NEJM (December 2017)

Bottom Line: This randomized, open-label, noninferiority trial compared oral edoxaban with subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism (VTE). A total of 1050 patients with acute symptomatic or incidental VTE were randomized to receive either edoxaban (60 mg once daily after ≥5 days of low-molecular-weight heparin) or dalteparin (200 IU/kg daily for 1 month, then 150 IU/kg daily) for a treatment duration of 6–12 months. The primary outcome, a composite of recurrent VTE or major bleeding within 12 months, occurred in 12.8% of patients in the edoxaban group and 13.5% in the dalteparin group (hazard ratio 0.97; 95% CI 0.70–1.36; P=0.006 for noninferiority). Recurrent VTE was less frequent with edoxaban (7.9% vs. 11.3%), but major bleeding was more frequent (6.9% vs. 4.0%). These findings suggest that oral edoxaban is noninferior to subcutaneous dalteparin for cancer-associated VTE, with a lower risk of recurrent VTE but a higher risk of major bleeding. Edoxaban may be a viable alternative for select patients with cancer-associated VTE.

LINK TO ARTICLE (Raskob et al.)

Thrombo Trial Files Issue #TBO-2025-01

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The WOMAN-2 Trial Collaborators. The Lancet (October 2024)

Bottom Line: This international, randomised, double-blind, placebo-controlled trial aimed to determine the effectiveness of tranexamic acid in preventing postpartum haemorrhage in women with moderate or severe anaemia. 14968 women were included in the intention-to-treat population and were randomly assigned to receive either tranexamic acid or placebo. The primary outcome was a clinical diagnosis of postpartum haemorrhage within 24 hours of randomisation. No significant difference was found between the intervention and control groups. Safety outcomes showed no vascular occlusive events or treatment-related adverse events.

LINK TO ARTICLE (WOMAN-2)

A randomized controlled trial evaluated the efficacy and safety of apixaban for prevention of recurrent thrombosis after thrombectomy of hemodialysis vascular access

Ko TY et al. Kidney International (November 2024)

Bottom Line: This multicenter randomized control study evaluated the efficacy and safety of apixaban in preventing recurrent access thrombosis in hemodialysis patients who underwent successful endovascular thrombectomy within 48 hours. Participants were assigned to standard care or standard care plus apixaban for three months. The apixaban group demonstrated a significantly lower rate of access thrombosis and better primary patency failure rate compared to the control group. Safety outcomes showed comparable death rates and major bleeding incidents, but a higher incidence of minor bleeding in the apixaban group. The net clinical benefit favors the use of apixaban in this context.

LINK TO ARTICLE (Ko et al.)

Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention of High-Risk Peptic Ulcers Rebleeding After Successful Endoscopic Hemostasis

Geeratragool T et al. Gastroenterology (September 2024)

Bottom Line: This multicenter, randomized, noninferiority study compared the efficacy of vonoprazan and high-dose PPI in preventing rebleeding of high-risk peptic ulcers after hemostasis. A total of 194 patients were included and randomized into 1:1 groups. The primary outcome was a 30-day rebleeding rate, which was found to be 7.1% in the vonoprazan group and 10.4% in the PPI group, with noninferiority confirmed. Secondary outcomes, including 3-day and 7-day rebleeding rates, all-cause and bleeding-related mortality, and safety, were also comparable between the two groups. In conclusion, vonoprazan was found to be noninferior to intravenous PPI in preventing rebleeding in patients with high-risk peptic ulcer bleeding.

LINK TO ARTICLE (Geeratragool et al.)

Thrombo Trial Files Issue #TBO-2024-14

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Schulman S et al. NEJM (June 1995)

Bottom Line: This multicenter trial compared the effectiveness of six weeks versus six months of oral anticoagulant therapy in patients with a first episode of venous thromboembolism. Of the 902 patients enrolled, 443 were randomly assigned to receive six weeks of therapy and 454 were assigned to receive six months. After two years of follow-up, the recurrence rate in the six-month group was significantly lower than in the six-week group. There was no difference in mortality or major hemorrhage between the two groups. The study was not blinded and was not funded by any specific source.

LINK TO ARTICLE (Schulman et al.)

Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer

Agnelli G et al. NEJM (March 2020)

Bottom Line: This multinational, randomized, investigator-initiated, open-label, noninferiority trial compared the use of oral apixaban and subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism. A total of 1155 patients were randomly assigned to receive either oral apixaban or subcutaneous dalteparin for 6 months. The primary outcome was recurrent venous thromboembolism during the trial period, and the principal safety outcome was major bleeding. Results showed that apixaban was noninferior to dalteparin in preventing recurrent venous thromboembolism without an increased risk of major bleeding. This study provides evidence for the use of oral apixaban as a safe and effective treatment option for cancer-associated venous thromboembolism.

LINK TO ARTICLE (Agnelli et al.)

Tinzaparin vs Warfarin for Treatment of Acute Venous Thromboembolism in Patients With Active Cancer

Lee AYY et al. JAMA (August 2015)

Bottom Line: This randomized, open-label study compared the efficacy and safety of tinzaparin versus warfarin for the treatment of acute, symptomatic VTE in patients with active cancer. The study included 900 adult patients from 164 centers across multiple continents. The primary outcome was recurrent VTE at 6 months, and the results showed no significant difference between the intervention and comparator groups. However, the intervention group did have a lower rate of clinically relevant nonmajor bleeding. There were no significant differences in major bleeding or overall mortality between the two groups. Further studies are needed to determine if the efficacy outcomes would be different in higher risk patients.

LINK TO ARTICLE (Lee et al.)

Thrombo Trial Files Issue #TBO-2024-13

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