The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study
Version 2 2024-06-03, 13:11Version 2 2024-06-03, 13:11
Version 1 2021-10-20, 16:22Version 1 2021-10-20, 16:22
journal contribution
posted on 2024-06-03, 13:11authored bySJ Connolly, L Wallentin, MD Ezekowitz, J Eikelboom, J Oldgren, PA Reilly, M Brueckmann, J Pogue, M Alings, JV Amerena, A Avezum, I Baumgartner, AJ Budaj, JH Chen, AL Dans, H Darius, G Di Pasquale, J Ferreira, GC Flaker, MD Flather, MG Franzosi, SP Golitsyn, DA Halon, H Heidbuchel, SH Hohnloser, K Huber, P Jansky, G Kamensky, M Keltai, SS Kim, CP Lau, JY Le Heuzey, BS Lewis, L Liu, J Nanas, R Omar, P Pais, KE Pedersen, LS Piegas, D Raev, PJ Smith, M Talajic, RS Tan, S Tanomsup, L Toivonen, D Vinereanu, D Xavier, J Zhu, SQ Wang, CO Duffy, E Themeles, S Yusuf
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.
Clinical Trial Registration—
URL:
http://www.clinicaltrials.gov
. Unique identifier: NCT00808067.