Acute Medically Ill VTE (Venous Thromboembolism) Prevention With Extended Duration Betrixaban - APEX
Contribution To Literature:
The APEX trial failed to show that extended-duration betrixaban was superior to short-duration enoxaparin at preventing thrombotic complications.
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.
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%
- 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)
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.
- 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
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.
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.
< Back to Listings