The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study

Stuart J Connolly, Lars Wallentin, Michael D Ezekowitz, John Eikelboom, Jonas Oldgren, Paul A Reilly, Martina Brueckmann, Janice Pogue, Marco Alings, John V Amerena, Alvaro Avezum, Iris Baumgartner, Andrzej J Budaj, Jyh-Hong Chen, Antonio L Dans, Harald Darius, Giuseppe Di Pasquale, Jorge Ferreira, Greg C Flaker, Marcus D Flather, Maria Grazia Franzosi, Sergey P Golitsyn, David A Halon, Hein Heidbuchel, Stefan H Hohnloser, Kurt Huber, Petr Jansky, Gabriel Kamensky, Matyas Keltai, Sung Soon Kim, Chu-Pak Lau, Jean-Yves Le Heuzey, Basil S Lewis, Lisheng Liu, John Nanas, Razali Omar, Prem Pais, Knud E Pedersen, Leopoldo S Piegas, Dimitar Raev, Pal J Smith, Mario Talajic, Ru San Tan, Supachai Tanomsup, Lauri Toivonen, Dragos Vinereanu, Denis Xavier, Jun Zhu, Susan Q Wang, Christine O Duffy, Ellison Themeles, Salim Yusuf
Circulation 2013 July 16, 128 (3): 237-43

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.

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