Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. - Université de Bretagne Occidentale Access content directly
Journal Articles New England Journal of Medicine Year : 2012

Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

Non Renseigné
  • Function : Author
Anthonie W A Lensin
  • Function : Author
Barry F Jacobson
  • Function : Author
Erich Minar
  • Function : Author
Jaromir Chlumsky
  • Function : Author
Peter Verhamme
Phil Wells
  • Function : Author
Giancarlo Agnelli
  • Function : Author
Alexander Cohen
  • Function : Author
Scott D Berkowitz
  • Function : Author
Bruce L Davidson
  • Function : Author
Frank Misselwitz
  • Function : Author
Alex S Gallus
  • Function : Author
Gary E Raskob
  • Function : Author
Sebastian Schellong
  • Function : Author
Annelise Segers
  • Function : Author

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.).

Dates and versions

hal-00721901 , version 1 (31-07-2012)

Identifiers

Cite

Non Renseigné, Harry R Büller, Martin H Prins, Anthonie W A Lensin, Hervé Decousus, et al.. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.. New England Journal of Medicine, 2012, 366 (14), pp.1287-97. ⟨10.1056/NEJMoa1113572⟩. ⟨hal-00721901⟩
286 View
1 Download

Altmetric

Share

Gmail Facebook X LinkedIn More