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Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

Publication ,  Journal Article
Patel, MR; Mahaffey, KW; Garg, J; Pan, G; Singer, DE; Hacke, W; Breithardt, G; Halperin, JL; Hankey, GJ; Piccini, JP; Becker, RC; Nessel, CC ...
Published in: N Engl J Med
September 8, 2011

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.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

September 8, 2011

Volume

365

Issue

10

Start / End Page

883 / 891

Location

United States

Related Subject Headings

  • Warfarin
  • Treatment Outcome
  • Thiophenes
  • Stroke
  • Rivaroxaban
  • Morpholines
  • Middle Aged
  • Male
  • Intention to Treat Analysis
  • Humans
 

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Patel, M. R., Mahaffey, K. W., Garg, J., Pan, G., Singer, D. E., Hacke, W., … ROCKET AF Investigators. (2011). Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med, 365(10), 883–891. https://doi.org/10.1056/NEJMoa1009638
Patel, Manesh R., Kenneth W. Mahaffey, Jyotsna Garg, Guohua Pan, Daniel E. Singer, Werner Hacke, Günter Breithardt, et al. “Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.N Engl J Med 365, no. 10 (September 8, 2011): 883–91. https://doi.org/10.1056/NEJMoa1009638.
Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883–91.
Patel, Manesh R., et al. “Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.N Engl J Med, vol. 365, no. 10, Sept. 2011, pp. 883–91. Pubmed, doi:10.1056/NEJMoa1009638.
Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KAA, Califf RM, ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883–891.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

September 8, 2011

Volume

365

Issue

10

Start / End Page

883 / 891

Location

United States

Related Subject Headings

  • Warfarin
  • Treatment Outcome
  • Thiophenes
  • Stroke
  • Rivaroxaban
  • Morpholines
  • Middle Aged
  • Male
  • Intention to Treat Analysis
  • Humans