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Apixaban for extended treatment of venous thromboembolism
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Background: Apixaban, an oral factor Xa inhibitor that can be administered in a simple, fixed-dose regimen, may be an option for the extended treatment of venous thromboembolism. Methods: in this randomized, double-blind study, we compared two doses of apixaban (2.5 mg and 5 mg, twice daily) with placebo in patients with venous thromboembolism who had completed 6 to 12 months of anticoagulation therapy and for whom there was clinical equipoise regarding the continuation or cessation of anticoagulation therapy. The study drugs were administered for 12 months. Results: a total of 2486 patients underwent randomization, of whom 2482 were included in the intention-to-treat analyses. Symptomatic recurrent venous thromboembolism or death from venous thromboembolism occurred in 73 of the 829 patients (8.8%) who were receiving placebo, as compared with 14 of the 840 patients (1.7%) who were receiving 2.5 mg of apixaban (a difference of 7.2 percentage points; 95% confidence interval [CI], 5.0 to 9.3) and 14 of the 813 patients (1.7%) who were receiving 5 mg of apixaban (a difference of 7.0 percentage points; 95% CI, 4.9 to 9.1) (P<0.001 for both comparisons). The rates of major bleeding were 0.5% in the placebo group, 0.2% in the 2.5-mg apixaban group, and 0.1% in the 5-mg apixaban group. The rates of clinically relevant nonmajor bleeding were 2.3% in the placebo group, 3.0% in the 2.5-mg apixaban group, and 4.2% in the 5-mg apixaban group. The rate of death from any cause was 1.7% in the placebo group, as compared with 0.8% in the 2.5-mg apixaban group and 0.5% in the 5-mg apixaban group. Conclusions: extended anticoagulation with apixaban at either a treatment dose (5 mg) or a thromboprophylactic dose (2.5 mg) reduced the risk of recurrent venous thromboembolism without increasing the rate of major bleeding. (Funded by Bristol Myers Squibb and Pfizer; AMPLIFY-EXT ClinicalTrials.gov number, NCT00633893).
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AGNELLI, Giancarlo, BULLER, Harry r., COHEN, Alexander, CURTO, Madelyn, GALLUS, Alexander s., JOHNSON, Margot, PORCARI, Anthony, RASKOB, Gary e., WEITZ, Jeffrey i., RIERA MESTRE, Antoni, AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. _New England Journal of Medicine_. 2012. Vol. 368, núm. 8, pàgs. 699-708. [consulta: 25 de febrer de 2026]. ISSN: 0028-4793. [Disponible a: https://hdl.handle.net/2445/178572]