Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial
Key result
Rivaroxaban matches warfarin for stroke prevention in valvular AF but increases relevant bleeding by ~25%.
Why the study?
Does rivaroxaban compared to warfarin reduce stroke or systemic embolism in patients with non-valvular atrial fibrillation and underlying significant native valvular disease?
Population
14,171 patients with non-valvular atrial fibrillation participating in the ROCKET AF trial, including 2,003…
Comparison
Rivaroxaban once daily oral vs Warfarin (vitamin K antagonism)
Design
Cohort, Randomized to rivaroxaban or warfarin in the main trial
Authors
Discussion
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Implication
Rivaroxaban was associated with similar stroke prevention but higher bleeding versus warfarin; leaves open randomized confirmation in AF with valvular disease.
Study Design
Type
RCT (n=14,171)
Randomization
randomized
Structured PICO
Does rivaroxaban compared to warfarin reduce stroke or systemic embolism in patients with non-valvular atrial fibrillation and underlying significant native valvular disease?
P
Population
14,171 patients with non-valvular atrial fibrillation participating in the ROCKET AF trial, including 2,003 (14.1%) with significant valvular disease (excluding mitral stenosis or artificial valve prostheses).
I
Intervention
Rivaroxaban once daily oral
C
Comparator
Warfarin (vitamin K antagonism)
O
Outcome
Stroke or systemic embolismcomposite
Main Result
Effect estimate: HR 0.83 (95% CI 0.55-1.27)
Absolute Event Rate: 2.01% vs 2.43%
In patients with atrial fibrillation and significant native valvular disease, rivaroxaban has similar efficacy to warfarin for stroke prevention but is associated with a higher risk of bleeding compared to patients without valvular disease.
Cite This Study
Breithardt et al. (2014) conducted an RCT in non-valvular atrial fibrillation with significant valvular disease (n=14,171). Rivaroxaban vs. Warfarin was evaluated on Stroke or systemic embolism in patients with significant valvular disease (HR 0.83, 95% CI 0.55-1.27). Rivaroxaban provided similar stroke prevention to warfarin in AF patients with significant valvular disease (HR 0.83; 95% CI 0.55-1.27) but increased relevant bleeding (HR 1.25; 95% CI 1.05-1.49).