Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation
Key result
Rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism, with a hazard ratio of 0.79 (95% CI, 0.66 to 0.96).
Why the study?
Does rivaroxaban prevent stroke or systemic embolism compared to warfarin in patients with nonvalvular atrial fibrillation?
Population
Patients with nonvalvular atrial fibrillation
Comparison
Rivaroxaban vs Warfarin
Design
RCT
Authors
Discussion
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Implication
Supports rivaroxaban as first-line option in nonvalvular AF; reinforces consensus for direct oral anticoagulants over warfarin.
Key Points
- To compare the effectiveness of rivaroxaban versus warfarin in preventing stroke or systemic embolism in patients with atrial fibrillation.
- Randomized trial
- Participants had nonvalvular atrial fibrillation
- ClinicalTrials.gov number NCT00403767
- Rivaroxaban was noninferior to warfarin for stroke prevention (p<0.05)
- No significant difference in the overall risk of major bleeding between groups
- Intracranial and fatal bleeding occurred less frequently in the rivaroxaban group
Study Design
Type
RCT (n=14,264)
Blinding
Double-blind
Randomization
Central computerized randomization
Multicenter
Yes
Structured PICO
Does rivaroxaban prevent stroke or systemic embolism compared to warfarin in patients with nonvalvular atrial fibrillation?
P
Population
Patients with nonvalvular atrial fibrillation
I
Intervention
Rivaroxaban
C
Comparator
Warfarin
O
Outcome
Stroke or systemic embolismhard clinical
Main Result
Effect estimate: HR 0.79 (95% CI 0.66-0.96)
Absolute Event Rate: 1.7% vs 2.2%
p-value: p=<0.001
Rivaroxaban is a noninferior alternative to warfarin for stroke prevention in nonvalvular atrial fibrillation, offering a lower risk of intracranial and fatal bleeding.
Limitations
- The study included a high proportion of patients with prior stroke or other risk factors, which may affect generalizability.
Cite This Study
Patel et al. (2011) conducted an RCT in Nonvalvular atrial fibrillation (n=14,264). Rivaroxaban vs. Warfarin (dose-adjusted) was evaluated on Composite of stroke (ischemic or hemorrhagic) and systemic embolism (HR 0.79, 95% CI 0.66-0.96, p=<0.001). Rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism, with a hazard ratio of 0.79 (95% CI, 0.66 to 0.96).