Oral Rivaroxaban for Symptomatic Venous Thromboembolism.

Rupert Bauersachs, Scott D. Berkowitz, Benjamin Brenner, Harry R. Buller*, Herve Decousus, Alex S. Gallus, Anthonie W. A. Lensing, Frank Misselwitz, Martin H. Prins, Gary E. Raskob, Annelise Segers, Peter Verhamme, Phil Wells, Giancarlo Agnelli, Henri Bounameaux, Alexander T. Cohen, Bruce L. Davidson, Franco Piovella, Sebastian M. Schellong

*Corresponding author for this work

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Abstract

Background: Rivaroxaban, an oral factor Xa inhibitor, may provide a simple, fixed-dose regimen for treating acute deep-vein thrombosis (DVT) and for continued treatment, without the need for laboratory monitoring. Methods: We conducted an open-label, randomized, event-driven, noninferiority study that compared oral rivaroxaban alone (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with subcutaneous enoxaparin followed by a vitamin K antagonist (either warfarin or acenocoumarol) for 3, 6, or 12 months in patients with acute, symptomatic DVT. In parallel, we carried out a double-blind, randomized, event-driven superiority study that compared rivaroxaban alone (20 mg once daily) with placebo for an additional 6 or 12 months in patients who had completed 6 to 12 months of treatment for venous thromboembolism. The primary efficacy outcome for both studies was recurrent venous thromboembolism. The principal safety outcome was major bleeding or clinically relevant nonmajor bleeding in the initial-treatment study and major bleeding in the continued-treatment study. Results: The study of rivaroxaban for acute DVT included 3449 patients: 1731 given rivaroxaban and 1718 given enoxaparin plus a vitamin K antagonist. Rivaroxaban had noninferior efficacy with respect to the primary outcome (36 events [2.1%], vs. 51 events with enoxaparin-vitamin K antagonist [3.0%]; hazard ratio, 0.68; 95% confidence interval [CI], 0.44 to 1.04; P
Original languageEnglish
Pages (from-to)2499-2510
JournalNew England Journal of Medicine
Volume363
Issue number26
DOIs
Publication statusPublished - 23 Dec 2010

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