November 13th, 2011
ADOPT Fails to Support Extended Oral Apixaban in High-Risk Post-Discharge Patients
Although medically ill patients remain at risk for VTE after hospital discharge, a strategy of extended oral anticoagulation with apixaban did not prove to be successful in the ADOPT (Apixaban Dosing to Optimize Protection from Thrombosis) trial, which was presented by Samuel Z. Goldhaber at the American Heart Association and published simultaneously in the New England Journal of Medicine.
ADOPT randomized 6528 acutely ill patients with at least one additional risk factor for venous thromboembolism (VTE) to standard care with subcutaneous enoxaparin 40 mg once daily for 6 to 14 days or oral apixaban 2.5 mg twice daily for 30 days. In all, 4495 were evaluated for the primary endpoint, a 30-day composite of death related to VTE, PE, symptomatic DVT, or asymptomatic proximal-leg DVT.
Incidence of the composite endpoint did not differ significantly between the two groups:
- 2.71% of the apixaban group versus 3.06% of the enoxaparin group (RR, 0.87; 95% CI, 0.62-1.23; P=0.44)
At 30 days, the incidence of major bleeding events was significantly higher in the apixaban group than in the enoxaparin group:
- 0.47% in the apixaban group versus 0.19% in the enoxaparin group (RR, 2.58; 95% CI, 1.02-7.24; P=0.04)