Oral rivaroxaban for the treatment of symptomatic pulmonary embolism - PubMed (original) (raw)

Randomized Controlled Trial

. 2012 Apr 5;366(14):1287-97.

doi: 10.1056/NEJMoa1113572. Epub 2012 Mar 26.

Harry R Büller, Martin H Prins, Anthonie W A Lensin, Hervé Decousus, Barry F Jacobson, Erich Minar, Jaromir Chlumsky, Peter Verhamme, Phil Wells, Giancarlo Agnelli, Alexander Cohen, Scott D Berkowitz, Henri Bounameaux, Bruce L Davidson, Frank Misselwitz, Alex S Gallus, Gary E Raskob, Sebastian Schellong, Annelise Segers

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Randomized Controlled Trial

Oral rivaroxaban for the treatment of symptomatic pulmonary embolism

EINSTEIN–PE Investigators et al. N Engl J Med. 2012.

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Abstract

Background: A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. This approach may also simplify the treatment of pulmonary embolism.

Methods: In a randomized, open-label, event-driven, noninferiority trial involving 4832 patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding.

Results: Rivaroxaban was noninferior to standard therapy (noninferiority margin, 2.0; P=0.003) for the primary efficacy outcome, with 50 events in the rivaroxaban group (2.1%) versus 44 events in the standard-therapy group (1.8%) (hazard ratio, 1.12; 95% confidence interval [CI], 0.75 to 1.68). The principal safety outcome occurred in 10.3% of patients in the rivaroxaban group and 11.4% of those in the standard-therapy group (hazard ratio, 0.90; 95% CI, 0.76 to 1.07; P=0.23). Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P=0.003). Rates of other adverse events were similar in the two groups.

Conclusions: A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile. (Funded by Bayer HealthCare and Janssen Pharmaceuticals; EINSTEIN-PE ClinicalTrials.gov number, NCT00439777.).

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