"Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation". The New England Journal of Medicine. 2011. 365:883-891. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcomes 8.2 Secondary Outcomes 8.3 Safety 9 Criticisms 10 Funding 11 Further Reading
Is rivaroxaban noninferior or superior to warfarin for the prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation?
In patients with nonvalvular atrial fibrillation, rivaroxaban is noninferior to warfarin for the prevention of stroke or systemic embolism. There were no significant differences in rates of major and clinically relevant nonmajor bleeding, although intracranial and fatal bleeding occurred less frequently with rivaroxaban.
Despite the demonstrated efficacy of warfarin for the prevention of stroke in patients with atrial fibrillation, its limitations include the requirement for frequent monitoring and dose adjustments. Rivaroxaban is an oral factor Xa inhibitor with potential benefits over warfarin. This trial, ROCKET AF, compared rivaroxaban with dose-adjusted warfarin for stroke and systemic embolism prevention in a high-risk cohort with atrial fibrillation.
As of 2011, no guidelines have been published incorporating the results of this trial.
- Multicenter, randomized, double-blind, double-dummy, event-driven trial - N=14,264 patients - Interventions: - Rivaroxaban 20 mg daily (15 mg daily if creatinine clearance 30-49 ml/min) - Dose-adjusted warfarin (target INR of 2.0 to 3.0) - Mean follow-up: 1.94 years
- Inclusion Criteria: Nonvalvular atrial fibrillation and increased risk of stroke - Exclusion Criteria: Active bleeding, liver disease, high bleeding risk, and others - Baseline Characteristics: A median age of 73 years, 39.7% female, history of hypertension in 90.5%, 62.5% with heart failure
- Fixed-dose rivaroxaban vs. adjusted-dose warfarin - INR monitoring with a blinded point-of-care device
Primary Outcomes - Stroke or systemic embolism: Rivaroxaban 1.7% per year vs. Warfarin 2.2% per year (HR 0.79, P<0.001 for noninferiority)
- Major and nonmajor clinically relevant bleeding: Rivaroxaban 14.9% per year vs. Warfarin 14.5% per year (HR 1.03, P=0.44) - Intracranial hemorrhage: Less frequent with rivaroxaban
Safety - Bleeding and hemorrhage: Similar major bleeding rates for both groups, with less fatal bleeding in the rivaroxaban group
- Lower than anticipated INR control in warfarin group - Rivaroxaban associated with a higher rate of gastrointestinal bleeding
Supported by Johnson & Johnson Pharmaceutical Research and Development and Bayer HealthCare.
The article "Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation" in NEJM, PubMed, Full text, and PDF.