Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients - AVERT
Contribution To Literature:
The AVERT trial showed that apixaban was superior to placebo at preventing venous thromboembolism; however, apixaban was associated with increased major bleeding.
The goal of the trial was to evaluate apixaban compared with placebo among patients with active cancer and elevated risk for venous thromboembolism.
Patients with active cancer and elevated risk for venous thromboembolism were randomized to apixaban 2.5 mg twice daily (n = 291) versus placebo (n = 283).
- Total number of enrollees: 574
- Duration of follow-up: 180 days
- Mean patient age: 61 years
- Percentage female: 58%
- Active cancer and undergoing chemotherapy
- Intermediate to high risk for venous thromboembolism
- Increased risk for bleeding
- Cancer diagnosis consisting solely of basal cell or squamous cell carcinoma, acute leukemia, or myeloproliferative neoplasm
- Planned stem cell transplantation
- Limited life expectancy
- Renal insufficiency
- Pregnancy or potential pregnancy
- Weight <88 lbs
The primary efficacy outcome, venous thromboembolism, occurred in 4.2% of the apixaban group compared with 10.2% of the placebo group (p < 0.001).
The primary safety outcome, major bleeding, occurred in 3.5% of the apixaban group compared with 1.8% of placebo group (p = 0.046).
The secondary outcome, all-cause mortality, was 12.2% in the apixaban group vs. 9.8% in the placebo group (p = not significant).
Among patients with active cancer undergoing chemotherapy, apixaban was associated with a reduction in venous thromboembolism compared with placebo. Apixaban was associated with an increase in major bleeding compared with placebo. All-cause mortality was similar between the treatment groups. Prevention of venous thromboembolism remains an important topic among active cancer patients and optimal treatment remains uncertain.
Carrier M, Abou-Nassar K, Mallick R, et al. Apixaban to Prevent Venous Thromboembolism in Patients With Cancer. N Engl J Med 2019;380:711-9.
Editorial: Agnelli G. Direct Oral Anticoagulants for Thromboprophylaxis in Ambulatory Patients With Cancer. N Engl J Med 2019;380:781-3.
Keywords: Anticoagulants, Cardiotoxicity, Hemorrhage, Neoplasms, Primary Prevention, Pyrazoles, Pyridones, Risk, Vascular Diseases, Venous Thromboembolism
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