Author(s): Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J,
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Abstract BACKGROUND: During follow-up of between 1 and 3 years in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, 2 doses of dabigatran etexilate were shown to be effective and safe for the prevention of stroke or systemic embolism in patients with atrial fibrillation. There is a need for longer-term follow-up of patients on dabigatran and for further data comparing the 2 dabigatran doses. METHODS AND RESULTS: Patients randomly assigned to dabigatran in RE-LY were eligible for the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit. Enrolled patients continued to receive the double-blind dabigatran dose received in RE-LY, for up to 28 months of follow up after RE-LY (median follow-up, 2.3 years). There were 5851 patients enrolled, representing 48\% of patients originally randomly assigned to receive dabigatran in RE-LY and 86\% of RELY-ABLE-eligible patients. Rates of stroke or systemic embolism were 1.46\% and 1.60\%/y on dabigatran 150 and 110 mg twice daily, respectively (hazard ratio, 0.91; 95\% confidence interval, 0.69-1.20). Rates of major hemorrhage were 3.74\% and 2.99\%/y on dabigatran 150 and 110 mg (hazard ratio, 1.26; 95\% confidence interval, 1.04-1.53). Rates of death were 3.02\% and 3.10\%/y (hazard ratio, 0.97; 95\% confidence interval, 0.80-1.19). Rates of hemorrhagic stroke were 0.13\% and 0.14\%/y. CONCLUSIONS: During 2.3 years of continued treatment with dabigatran after RE-LY, there was a higher rate of major bleeding with dabigatran 150 mg twice daily in comparison with 110 mg, and similar rates of stroke and death. TRIAL REGISTRATION: ClinicalTrials.gov NCT00808067.
This article was published in Circulation
and referenced in Journal of Blood Disorders & Transfusion