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ADVANCE-2: Apixaban had favorable risk-benefit profile compared with enoxaparin
ISTH 2009
Apixaban for thromboprophylaxis after total knee replacement had better efficacy and safety compared with the current standard of care, enoxaparin, according to the results of a late-breaking abstract of the ADVANCE-2 study presented Monday.
Results from the ADVANCE-1 study, presented in December 2008 at the 50th ASH Annual Meeting, showed that apixaban failed to meet one of two prespecified noninferiority criteria margins in reducing rates of venous thromboembolism but showed lower major and clinically relevant non-major bleeding rates in patients undergoing total knee replacement. In ADVANCE-1, researchers compared apixaban with the North American dosage of enoxaparin (Lovenox, Sanofi Aventis) 30 mg twice daily.
Michael Lassen, MD, of the University of Copenhagen, Hørsholm, Denmark, presented the results of ADVANCE-2 (n=3,057), a randomized, double blind, multicenter trial. Researchers compared the efficacy and safety of 2.5 mg apixaban twice daily for preventing venous thromboembolism vs. the current European standard of care, 40 mg subcutaneous enoxaparin once daily.
Primary efficacy outcome was the composite of DVT by venography, symptomatic objectively confirmed DVT or pulmonary embolism, or death from any cause during treatment. Primary safety outcome was bleeding (major and clinically relevant non-major).
The primary outcome occurred in 15.1% of patients in the apixaban group vs. 24.4% in the enoxaparin group (P<.001). Major venous thromboembolism occurred in 1.1% of apixaban patients vs. 2.2% of enoxaparin patients.
Apixaban also conferred a better safety profile compared with enoxaparin (3.5% vs. 4.8%; P=.09).
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