Rivaroxaban versus warfarin in nonvalvular atrial fibrillation / Manesh R. Patel, M.D., Kenneth W. Mahaffey, M.D., Jyotsna Garg, M.S., Guohua Pan, Ph.D., Daniel E. Singer, M.D., Werner Hacke, M.D., Ph.D., Günter Breithardt, M.D., Jonathan L. Halperin, M.D., Graeme J. Hankey, M.D., Jonathan P. Piccini, M.D., Richard C. Becker, M.D., Christopher C. Nessel, M.D., John F. Paolini, M.D., Ph.D., Scott D. Berkowitz, M.D., Keith A.A. Fox, M.B., Ch.B., Robert M. Califf, M.D., and the ROCKET AF Steering Committee, for the ROCKET AF Investigators*

BACKGROUND: The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin. - METHODS: In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. - RESULTS: In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group. - CONCLUSIONS: In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.)..

Medienart:

E-Artikel

Erscheinungsjahr:

2011

Erschienen:

2011

Enthalten in:

Zur Gesamtaufnahme - volume:365

Enthalten in:

The New England journal of medicine - 365(2011), 10, Seite 883-91

Sprache:

Englisch

Beteiligte Personen:

Patel, Manesh [VerfasserIn]
Mahaffey, Kenneth W. [VerfasserIn]
Garg, Jyotsna [VerfasserIn]
Pan, Guohua [VerfasserIn]
Singer, Daniel E. [VerfasserIn]
Hacke, Werner, 1948- [VerfasserIn]
Breithardt, Günter [VerfasserIn]
Halperin, Jonathan L. [VerfasserIn]
Hankey, Graeme J. [VerfasserIn]
Piccini, Jonathan P. [VerfasserIn]
Becker, Richard C. [VerfasserIn]
Nessel, Christopher C. [VerfasserIn]
Paolini, John F. [VerfasserIn]
Berkowitz, Scott D. [VerfasserIn]
Fox, Keith A. A. [VerfasserIn]
Califf, Robert M. [VerfasserIn]

Links:

Volltext [lizenzpflichtig]
Volltext

Themen:

Administration, Oral
Aged
Aged, 80 and over
Anticoagulants
Atrial Fibrillation
Double-Blind Method
Embolism
Female
Hemorrhage
Humans
Intention to Treat Analysis
Male
Middle Aged
Morpholines
Rivaroxaban
Stroke
Thiophenes
Treatment Outcome
Warfarin

Anmerkungen:

Gesehen am 18.11.2014

Umfang:

9

doi:

10.1056/NEJMc1112233

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

1487149204

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