Rivaroxaban versus warfarin in nonvalvular atrial fibrillation

Patel, Manesh R.; Mahaffey, Kenneth W.; Garg, Jyotsna; Pan, Guohua; Singer, Daniel E.; Hacke, Werner; Breithardt, Günter; Halperin, Jonathan L.; Hankey, Graeme J.; Piccini, Jonathan P.; Becker, Richard C.; Nessel, Christopher C.; Paolini, John F.; Berkowitz, Scott D.; Fox, Keith A.A.; Califf, Robert M.; the ROCKET AF Steering Committee

doi:10.1056/nejmoa1009638

Cited by 9,430Atrial Fibrillation Management and OutcomesVenous Thromboembolism Diagnosis and ManagementAcute Ischemic Stroke Management

Rivaroxaban versus warfarin in nonvalvular atrial fibrillation

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Patel, Manesh R., Mahaffey, Kenneth W., Garg, Jyotsna, Pan, Guohua, Singer, Daniel E., Hacke, Werner, Breithardt, Günter, Halperin, Jonathan L. +9 more·2011·New England Journal of Medicine

DOI 10.1056/nejmoa1009638

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Abstract

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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There was an increase in gastrointestinal bleeding events, but a significant reduction in haemorrhagic stroke and intracranial haemorrhage with rivaroxaban compared with warfarin.
“There was an increase in gastrointestinal bleeding events, but a significant reduction in haemorrhagic stroke and intracranial haemorrhage with rivaroxaban compared with warfarin.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [320]
In the ROCKET-AF trial, rivaroxaban was non-inferior to warfarin for prevention of stroke and systemic embolism in the intent-to-treat analysis, while the per-protocol on-treatment analysis achieved statistical superiority with a 21% reduction in stroke or systemic embolism compared with warfarin.
“Rivaroxaban was non-inferior to warfarin for the prevention of stroke and systemic embolism in the intent-to-treat analysis, while the per-protocol on-treatment analysis achieved statistical superiority with a 21% reduction in stroke or systemic embolism compared with warfarin.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [320]
Rivaroxaban did not reduce the rates of mortality, ischaemic stroke, or major bleeding events compared to vitamin K antagonist.
“Rivaroxaban did not reduce the rates of mortality, ischaemic stroke, or major bleeding events compared to VKA.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [320]
Rivaroxaban has 35% renal clearance.
“Renal clearance”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [320]

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Authors: Patel, M. R., Mahaffey, K. W., Garg, J., Pan, G., Singer, D. E., Hacke, W., Breithardt, G., Halperin, J. L., Hankey, G. J., Piccini, J. P., Becker, R. C., Nessel, C. C., Paolini, J. F., Berkowitz, S. D., Fox, K. A. A., Califf, R. M., & the ROCKET AF Steering Committee
Affiliations: Duke Medical Center (US)
Janssen Research & Development (United States) (US)
Harvard University (US)
Heidelberg University (DE)
University of Münster (DE)
Mount Sinai Hospital (US)
Royal Perth Hospital (AU)
Edinburgh Royal Infirmary (GB)
ORCID: Patel, Manesh R.
Mahaffey, Kenneth W.
Pan, Guohua
Singer, Daniel E.
Breithardt, Günter
Halperin, Jonathan L.
Hankey, Graeme J.
Piccini, Jonathan P.
Becker, Richard C.
Nessel, Christopher C.
Paolini, John F.
Berkowitz, Scott D.
Fox, Keith A.A.
Califf, Robert M.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2011-09-08
Volume: 365
Issue: 10
Pages: 883-891
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1009638
OpenAlex: W2097854437
Cited by: 9,430
References: 27
Citations by year: 2026: 248 · 2025: 372 · 2024: 446 · 2023: 515 · 2022: 551 · 2021: 658 · 2020: 711 · 2019: 636 · 2018: 755 · 2017: 707 · 2016: 794 · 2015: 786 · 2014: 758 · 2013: 774 · 2012: 604
FWCI: 488.96
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
UWA Profiles and Research Repository (UWA) (submittedVersion)
LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, other-oa)
HAL (submittedVersion)
Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
Archivio Istituzionale della Ricerca - Università degli Studi dell Aquila (submittedVersion)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
Keywords: rivaroxaban, warfarin, non-valvular atrial fibrillation, factor Xa inhibitors, oral anticoagulation, stroke prevention, systemic embolism, intracranial hemorrhage, bleeding risk, non-inferiority, ischemic stroke, anticoagulation monitoring, dose adjustment
MeSH terms: Rivaroxaban, Administration, Oral, Aged, Aged, 80 and over, Anticoagulants, Atrial Fibrillation, Double-Blind Method, Embolism, Female, Hemorrhage, Humans, Male, Middle Aged, Morpholines, Thiophenes, Warfarin, Treatment Outcome, Stroke, Intention to Treat Analysis

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Rivaroxaban versus warfarin in nonvalvular atrial fibrillation

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