Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients - AVERT

Feb 21, 2019
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Canadian Institutes of Health Research, and Bristol-Myers Squibb–Pfizer Alliance
Date Published:
12/04/2018
Date Updated:
02/21/2019
Original Posted Date:
01/16/2019
References

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.

Description:

The goal of the trial was to evaluate apixaban compared with placebo among patients with active cancer and elevated risk for venous thromboembolism.

Study Design

  • Randomized
  • Parallel
  • Blinded

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%

Inclusion criteria:

  • Active cancer and undergoing chemotherapy
  • Intermediate to high risk for venous thromboembolism

Exclusion criteria:

  • 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
  • Thrombocytopenia
  • Pregnancy or potential pregnancy
  • Weight <88 lbs

Principal Findings:

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).

Interpretation:

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.

References:

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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