April 24, 2006Archives of Internal Medicine
Comparison of Bleeding in Patients With Nonvalvular Atrial Fibrillation Treated With Ximelagatran or Warfarin
Key result
Ximelagatran significantly reduced the annual incidence of any bleeding compared to warfarin in patients with nonvalvular atrial fibrillation (31.75% vs 38.82%; RRR 18.2%; 95% CI 13.0-23.1; P<.001).
Why the study?
Does ximelagatran reduce bleeding compared to warfarin in patients with nonvalvular atrial fibrillation?
Population
7329 patients with nonvalvular atrial fibrillation from the Stroke Prevention Using Oral Thrombin Inhibitor…
Comparison
Ximelagatran, 36 mg twice daily vs Warfarin sodium
Design
Meta-analysis
Follow-up
24 months
Authors
Discussion
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Implication
Ximelagatran may be preferred over warfarin to reduce bleeding in nonvalvular AF; confirms safety advantage in meta-analysis of two RCTs.
Study Design
Type
Meta-Analysis (n=7,329)
Structured PICO
Does ximelagatran reduce bleeding compared to warfarin in patients with nonvalvular atrial fibrillation?
P
Population
7329 patients with nonvalvular atrial fibrillation from the Stroke Prevention Using Oral Thrombin Inhibitor in Atrial Fibrillation III and V trials
I
Intervention
Ximelagatran, 36 mg twice daily
C
Comparator
Warfarin sodium (target international normalized ratio, 2.0-3.0)
O
Outcome
Annual risk of bleeding (any, major)safety
Main Result
Effect estimate: RRR 18.2% (95% CI 13.0-23.1)
Absolute Event Rate: 31.75% vs 38.82%
p-value: p=<.001
Ximelagatran 36 mg twice daily is associated with a significantly lower risk of any and major bleeding compared to warfarin in patients with nonvalvular atrial fibrillation.
Cite This Study
Douketis et al. (2006) conducted a meta-analysis in Nonvalvular atrial fibrillation (n=7,329). Ximelagatran vs. Warfarin sodium (target INR 2.0-3.0) was evaluated on Annual incidence of any bleeding (RRR 18.2%, 95% CI 13.0-23.1, p=<.001). Ximelagatran significantly reduced the annual incidence of any bleeding compared to warfarin in patients with nonvalvular atrial fibrillation (31.75% vs 38.82%; RRR 18.2%; 95% CI 13.0-23.1; P<.001).