RE-LY (dabigatran 150 mg)
Trial question
What is the role of dabigatran in patients with AF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 12098
12098 patients (4449 female, 7649 male).
Inclusion criteria: patients who had AF and a risk of stroke.
Key exclusion criteria: severe valvular heart disease; stroke within 14 days or severe stroke within 6 months before screening; conditions increasing the risk of hemorrhage; CrCl < 30 mL/min; active liver disease; pregnancy.
Interventions
N=6076 dabigatran (at a dose of 150 mg BID).
N=6022 warfarin (at a dose of 1, 3, or 5 mg to maintain an INR of 2.0-3.0).
Primary outcome
Incidence of stroke or systemic embolism
1.11% / y
1.69% / y
1.7 % / y
1.3 % / y
0.8 % / y
0.4 % / y
0.0 % / y
Dabigatran
Warfarin
Significant
decrease ▼
Significant decrease in the incidence of stroke or systemic embolism (1.11% / y vs. 1.69% / y; RR 0.66, 95% CI 0.53 to 0.82).
Secondary outcomes
Significant decrease in the incidence of stroke (1.01% / y vs. 1.57% / y; RR 0.64, 95% CI 0.51 to 0.81).
No significant difference in the incidence of PE (0.15% / y vs. 0.09% / y; RR 1.61, 95% CI 0.76 to 3.42).
Borderline significant decrease in the incidence of death (3.64% / y vs. 4.13% / y; RR 0.88, 95% CI 0.77 to 1).
Safety outcomes
No significant difference in major bleeding.
Significant differences in minor bleeding (14.84% per year vs. 16.37% per year), net clinical benefit outcome (6.91% per year vs. 7.64% per year).
Conclusion
In patients who had AF and a risk of stroke, dabigatran was superior to warfarin with respect to the incidence of stroke or systemic embolism.
Reference
Stuart J Connolly, Michael D Ezekowitz, Salim Yusuf et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51.
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