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Rivaroxaban versus warfarin in nonvalvular atrial fibrillation

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dc.creatorPatel, Maneshspa
dc.creatorMahaffey, Kennethspa
dc.creatorGarg, Jyotsnaspa
dc.creatorPan, Guohuaspa
dc.creatorSinger, Danielspa
dc.creatorHacke, Wernerspa
dc.creatorBreithardt, Gunterspa
dc.creatorHalperin, Jonathanspa
dc.creatorHankey, Graemespa
dc.creatorPiccini, Jonathanspa
dc.creatorBecker, Richardspa
dc.creatorNessel, Christopherspa
dc.date.accessioned2020-08-19T14:40:31Z
dc.date.available2020-08-19T14:40:31Z
dc.date.created2011-09-08spa
dc.description.abstractBACKGROUND 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. opens in new tab.)eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1056/NEJMoa1009638
dc.identifier.issnISSN: 0028-4793
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/26913
dc.language.isoengspa
dc.publisherMassachusetts Medical Societyspa
dc.relation.citationEndPage891
dc.relation.citationIssueNo. 10
dc.relation.citationStartPage883
dc.relation.citationTitleThe New England Journal of Medicine
dc.relation.citationVolumeVol. 365
dc.relation.ispartofThe New England Journal of Medicine, ISSN: 0028-4793, Vol.365, No.10 (2011);pp. 883-891spa
dc.relation.urihttps://www.nejm.org/doi/pdf/10.1056/NEJMoa1009638?articleTools=truespa
dc.rights.accesRightsinfo:eu-repo/semantics/openAccess
dc.rights.accesoAbierto (Texto Completo)spa
dc.sourceThe New England Journal of Medicinespa
dc.source.instnameinstname:Universidad del Rosario
dc.source.reponamereponame:Repositorio Institucional EdocUR
dc.subject.keywordRandomizationspa
dc.subject.keywordHypertensionspa
dc.subject.keywordDiabetesspa
dc.titleRivaroxaban versus warfarin in nonvalvular atrial fibrillationspa
dc.title.TranslatedTitleRivaroxabán versus warfarina en la fibrilación auricular no valvularspa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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