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).
RCT (n=14,264)
Double-blind
Central computerized randomization
Yes
Does rivaroxaban prevent stroke or systemic embolism compared to warfarin in patients with nonvalvular atrial fibrillation?
Rivaroxaban is a noninferior alternative to warfarin for stroke prevention in nonvalvular atrial fibrillation, offering a lower risk of intracranial and fatal bleeding.
Effect estimate: HR 0.79 (95% CI 0.66-0.96)
Absolute Event Rate: 1.7% vs 2.2%
p-value: p=<0.001
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 ROCKET AF ClinicalTrials.gov number, NCT00403767.).
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).