ADOPT Fails to Support Extended Oral Apixaban in High-Risk Post-Discharge Patients

November 13th, 2011

ADOPT Fails to Support Extended Oral Apixaban in High-Risk Post-Discharge Patients

Larry Husten, PHD

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)

The authors concluded that ADOPT “does not provide evidence to justify a policy of extended prophylaxis in a broad population of medically ill patients after hospital discharge.” But, they noted, the high rate of VTE after discharge suggests the need for better risk-stratification methods “to identify a narrower spectrum of medically ill patients who may benefit from extended prophylaxis.”

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November 13th, 2011