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

November 13, 2011 by Leave a Comment

Although medically ill patients remain at risk for VTE after hospital discharge, a strategy of extended oral anticoagulation with apixaban did not prove 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 6,528 acutely ill patients with at least one additional risk factor for venous thromboembolism (VTE) to standard care with subcutaneous enoxaparin once daily for 6-14 days or oral apixaban 2.5 mg twice daily for 30 days. 4,495 were evaluated for the primary endpoint, which was the 30 day composite of death related to VTE, PE, symptomatic DVT, or asymptomatic proximal-leg DVT.

There was no significant difference in the incidence of the composite endpoint between the two groups:

  • 2.71% of the apixaban group versus 3.06% versus 3.06% in the enoxaparin group (RR 0.87, CI 0.62-1.23, p=0.44)

At 30 days bleeding events were significantly higher in the apixaban group compared to the enoxaparin group:

  • 0.47% in the apixaban group versus 0.19% in the enoxaparin group (RR 2.58, 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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