Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism

Harry R. Bueller*, Herve Decousus, Michael A. Grosso, Michele Mercuri, Saskia Middeldorp, Martin H. Prins, Gary E. Raskob, Sebastian M. Schellong, Lee Schwocho, Annelise Segers, Minggao Shi, Peter Verhamme, Phil Wells

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Background Whether the oral factor Xa inhibitor edoxaban can be an alternative to warfarin in patients with venous thromboembolism is unclear. MethodsIn a randomized, double-blind, noninferiority study, we randomly assigned patients with acute venous thromboembolism, who had initially received heparin, to receive edoxaban at a dose of 60 mg once daily, or 30 mg once daily (e.g., in the case of patients with creatinine clearance of 30 to 50 ml per minute or a body weight below 60 kg), or to receive warfarin. Patients received the study drug for 3 to 12 months. The primary efficacy outcome was recurrent symptomatic venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding. ResultsA total of 4921 patients presented with deep-vein thrombosis, and 3319 with a pulmonary embolism. Among patients receiving warfarin, the time in the therapeutic range was 63.5%. Edoxaban was noninferior to warfarin with respect to the primary efficacy outcome, which occurred in 130 patients in the edoxaban group (3.2%) and 146 patients in the warfarin group (3.5%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.70 to 1.13; P
Original languageEnglish
Pages (from-to)1406-1415
JournalNew England Journal of Medicine
Volume369
Issue number15
DOIs
Publication statusPublished - 10 Oct 2013

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