February 8, 2005JAMA
Ximelagatran vs Warfarin for Stroke Prevention in Patients With Nonvalvular Atrial Fibrillation
Why the study?
Does fixed-dose oral ximelagatran prevent stroke and systemic embolic events in patients with nonvalvular atrial fibrillation compared to adjusted-dose warfarin?
Population
3,922 patients with nonvalvular atrial fibrillation and additional stroke risk factors
Comparison
Fixed-dose oral ximelagatran, 36 mg twice daily vs Adjusted-dose warfarin
Design
RCT, randomized, Double-blind
Follow-up
mean 20 months
Authors
Discussion
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Member takes
Implication
Supports fixed-dose ximelagatran as alternative to warfarin for thromboembolism prevention in nonvalvular AF; extends oral anticoagulation options beyond vitamin K antagonists.
Structured PICO
Does fixed-dose oral ximelagatran prevent stroke and systemic embolic events in patients with nonvalvular atrial fibrillation compared to adjusted-dose warfarin?
P
Population
3,922 patients with nonvalvular atrial fibrillation and additional stroke risk factors
I
Intervention
Fixed-dose oral ximelagatran, 36 mg twice daily
C
Comparator
Adjusted-dose warfarin (aiming for an international normalized ratio [INR] 2.0 to 3.0)
O
Outcome
Composite of all strokes (ischemic or hemorrhagic) and systemic embolic eventscomposite
Fixed-dose oral ximelagatran is noninferior to well-controlled warfarin for the prevention of thromboembolism in patients with nonvalvular atrial fibrillation, though it is associated with a higher risk of hepatotoxicity.
Cite This Study
Albers et al. (2005) studied this question.