The Long Term Multi-Center Observational Study of Dabigatran Treatment in Patients with Atrial Fibrillation: (RELY-ABLE) Study
Background—During follow up of between 1 and 3 years in the RE-LY trial, two doses of dabigatran etexilate were shown to be effective and safe for prevention of stroke or systemic embolism in patients with atrial fibrillation (AF). There is a need for longer term follow up of patients on dabigatran and for further data comparing the two dabigatran doses.
Methods and Results—Patients randomized to dabigatran in RE-LY were eligible for RELY-ABLE 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 randomized 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 %/year on dabigatran 150 and 110 mg bid, respectively (hazard ratio (HR) 0.91, 95% confidence interval (CI), 0.69-1.20). Rates of major hemorrhage were 3.74 and 2.99 %/year on dabigatran 150 and 110 mg (HR 1.26, 95% CI, 1.04-1.53). Rates of death were 3.02 and 3.10 %/year (HR 0.97; 95% CI 0.80-1.19). Rates of hemorrhagic stroke were; 0.13 and 0.14%/year.
Conclusions—During 2.3 years continued treatment with dabigatran after RE-LY, there was a higher rate of major bleeding with dabigatran 150 mg twice daily compared to 110 mg, and similar rates of stroke and death.
Clinical Trial Registration Information—Clinicaltrials.gov; Identifier: NCT00808067.
- Received January 7, 2013.
- Revision received April 8, 2013.
- Accepted May 6, 2013.