Acute Medically Ill VTE (Venous Thromboembolism) Prevention With Extended Duration Betrixaban - APEX

Aug 31, 2016
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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:
Portola Pharmaceuticals
Date Published:
08/11/2016
Date Updated:
08/31/2016
Original Posted Date:
08/31/2016
References

Contribution To Literature:

The APEX trial failed to show that extended-duration betrixaban was superior to short-duration enoxaparin at preventing thrombotic complications.

Description:

The goal of the trial was to evaluate treatment with extended-duration oral betrixaban compared with short-duration subcutaneous enoxaparin among patients hospitalized for acute medical illness.

Study Design

  • Randomized
  • Parallel
  • Blinded
  • Placebo

Patients hospitalized with an acute medical illness were randomized to oral betrixaban for 35-42 days (n = 3,759) versus subcutaneous enoxaparin for 10 days (n = 3,754).

  • Total number of enrollees: 7,513
  • Mean patient age: 77 years
  • Percentage female: 55%

Inclusion criteria:

  • At least 40 years of age
  • Hospitalized <96 hours for acute medical illness
  • Reduced mobility and risk factors for thromboembolism
  • Elevated D-dimer (cohort 1)
  • Elevated D-dimer or age ≥75 years (cohort 2)

Principal Findings:

The primary outcome, incidence of asymptomatic proximal deep-vein thrombosis or symptomatic venous thromboembolism, occurred in 6.9% of the betrixaban group versus 8.5% of the enoxaparin group (p = 0.054). Since this difference was not significant, further analyses in cohort 2 and the entire cohort were considered exploratory.

Secondary outcomes:

  • Asymptomatic proximal deep-vein thrombosis or symptomatic venous thromboembolism in cohort 2: 5.6% versus 7.1% (p = 0.03), respectively, for betrixaban versus enoxaparin
  • Major bleeding in entire cohort: 0.7% versus 0.6% (p = 0.55), respectively, for betrixaban versus enoxaparin

Interpretation:

Among patients hospitalized with an acute medical illness, extended-duration betrixaban was not superior to short-duration enoxaparin in preventing thrombotic complications. Although there was no benefit in cohort 1, betrixaban was associated with a reduction in thrombotic complications in exploratory cohorts. Bleeding was similar between the groups.

References:

Cohen AT, Harrington RA, Goldhaber SZ, et al. Extended Thromboprophylaxis With Betrixaban in Acutely Ill Medical Patients. N Engl J Med 2016;375:534-44.

Clinical Topics: Anticoagulation Management, Geriatric Cardiology, Prevention, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Anticoagulation Management and Venothromboembolism

Keywords: Anticoagulants, Benzamides, Critical Illness, Enoxaparin, Geriatrics, Primary Prevention, Pyridines, Risk Factors, Venous Thromboembolism, Venous Thrombosis


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