RE-LY

Randomized Evaluation of Long-term anticoagulant therapY (2009)

Condition

Anticoagulation in AF

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Objective

To compare the efficacy and safety of two dose regimens of dabigatran vs. warfarin in patients with non-valvular AF

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Trial design

Randomized, partially blinded (warfarin: open; dabigatran: closed) phase III study, non-inferiority trial
Active treatment: dabigatran 110 mg (n=6015) or 150 mg (n=6076) p.o. twice daily, for 2 years, in a blinded fashion
Control treatment: warfarin (INR 2.0–3.0); for 2 years, in an unblinded fashion (n=6022)

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Endpoints

Primary efficacy endpoint: composite of stroke or systemic embolism
Primary safety endpoint: major bleeding
Secondary endpoints: stroke, systemic embolism and death

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Trial participants

18,113 patients (mean age 71 years), with AF documented within 6 months before screening and ≥1 risk factor (previous stroke or TIA, LVEF<40%, NYHA ≥II or higher heart failure symptoms)

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Results

Efficacy outcome: The primary endpoint (stroke or systemic embolism) showed an annual event rate of 1.5% in patients given 110 mg dabigatran twice daily, of 1.1% in patients given 150 mg dabigatran twice daily and of 1.7% in patients given warfarin
Safety outcome: The annual event rate of major bleeding was 2.7% in patients receiving 110 mg dabigatran twice daily, 3.1% in patients receiving 150 mg dabigatran twice daily and 3.4% in patients receiving warfarin. The only adverse event occurring significantly more often in patients receiving dabigatran when compared to warfarin was dyspepsia (110 mg dabigatran: 11.8%, 150 mg dabigatran: 11.3%, and warfarin: 5.8%)

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Summary

Efficacy: Both dabigatran dosage regimens showed lower rates of stroke or systemic embolism when compared to warfarin, only reaching statistical significance in 150 mg dabigatran twice daily. Compared to warfarin a significantly lower annual event rate of hemorrhagic strokes occured in both dabigatran dosage regimens
Safety: Both doses of dabigatran markedly reduced intra-cerebral, lifethreatening and total bleeding compared to warfarin. Dabigatran had no major toxicity, but did increase dyspepsia and gastrointestinal bleeding

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Reference

Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener H-C, Joyner C D, Wallentin L, and the RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-1151

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Corresponding author

Stuart Connolly, MD, Population Health Research Institute, 237 Barton Street East, Hamilton, ON L8L 2X2, Canada, e-mail: connostu@phri.ca

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