RE-LY (dabigatran 110 mg)
Trial question
Is dabigatran noninferior to warfarin in patients with AF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 12037
12037 patients (4363 female, 7674 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=6015 dabigatran (at a dose of 110 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
1.53% / y
1.69% / y
1.7 % / y
1.3 % / y
0.8 % / y
0.4 % / y
0.0 % / y
Dabigatran
Warfarin
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the incidence of stroke or systemic embolism (1.53% / y vs. 1.69% / y; RR 0.91, 95% CI 0.74 to 1.11).
Secondary outcomes
No significant difference in the incidence of stroke (1.44% / y vs. 1.57% / y; RR 0.92, 95% CI 0.74 to 1.13).
No significant difference in the incidence of PE (0.12% / y vs. 0.09% / y; RR 1.26, 95% CI 0.57 to 2.78).
No significant difference in the incidence of death (3.75% / y vs. 4.13% / y; RR 0.91, 95% CI 0.8 to 1.03).
Safety outcomes
No significant difference in net clinical benefit outcome.
Significant differences in major bleeding (2.71% per year vs. 3.36% per year), minor bleeding (13.16% per year vs. 16.37% per year).
Conclusion
In patients who had AF and a risk of stroke, dabigatran was noninferior 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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