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Title

Oral rivaroxaban for symptomatic venous thromboembolism

Authors
Bauersachs, R.
Berkowitz, S. D.
Brenner, B.
Buller, H. R.
Decousus, H.
Gallus, A. S.
Lensing, A. W.
Misselwitz, F.
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Published in New England Journal of Medicine. 2010, vol. 363, no. 26, p. 2499-2510
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<0.001). The principal safety outcome occurred in 8.1% of the patients in each group. In the continued-treatment study, which included 602 patients in the rivaroxaban group and 594 in the placebo group, rivaroxaban had superior efficacy (8 events [1.3%], vs. 42 with placebo [7.1%]; hazard ratio, 0.18; 95% CI, 0.09 to 0.39; P<0.001). Four patients in the rivaroxaban group had nonfatal major bleeding (0.7%), versus none in the placebo group (P=0.11). CONCLUSIONS: Rivaroxaban offers a simple, single-drug approach to the short-term and continued treatment of venous thrombosis that may improve the benefit-to-risk profile of anticoagulation. (Funded by Bayer Schering Pharma and Ortho-McNeil; ClinicalTrials.gov numbers, NCT00440193 and NCT00439725.).
Keywords Acenocoumarol/adverse effects/therapeutic useAcute DiseaseAdministration, OralAgedAnticoagulants/adverse effects/*therapeutic useDouble-Blind MethodEnoxaparin/adverse effects/*therapeutic useFactor Xa/*antagonists & inhibitorsFemaleHemorrhage/chemically inducedHumansInjections, SubcutaneousIntention to Treat AnalysisKaplan-Meier EstimateMaleMiddle AgedMorpholines/adverse effects/*therapeutic usePulmonary Embolism/*drug therapyThiophenes/adverse effects/*therapeutic useVenous Thromboembolism/drug therapyVenous Thrombosis/*drug therapyVitamin K/*antagonists & inhibitorsWarfarin/adverse effects/therapeutic use
Identifiers
PMID: 21128814
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Other version: http://www.nejm.org/doi/pdf/10.1056/NEJMoa1007903
Structures
Research groups Geneva Platelet Group (13)
La maladie thromboembolique veineuse (808)
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(ISO format)
BAUERSACHS, R. et al. Oral rivaroxaban for symptomatic venous thromboembolism. In: New England Journal of Medicine, 2010, vol. 363, n° 26, p. 2499-2510. https://archive-ouverte.unige.ch/unige:20763

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Deposited on : 2012-05-23

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