Connolly, S. J.2; Wallentin, L.2; Ezekowitz, M. D.2; Eikelboom, J.2; Oldgren, J.2; Reilly, P. A.2; Brueckmann, M.2; Pogue, J.2; Alings, M.2; Amerena, J. V.2; Avezum, A.2; Baumgartner, I.2; Budaj, A. J.2; Chen, J. H.2; Dans, A. L.2; Darius, H.2; Di Pasquale, G.2; Ferreira, J.2; Flaker, G. C.2; Flather, M. D.2; Franzosi, M. G.2; Golitsyn, S. P.2; Halon, D. A.2; Heidbuchel, H.2; Hohnloser, S. H.2; Huber, K.2; Jansky, P.2; Kamensky, G.2; Keltai, M.2; Kim, S. S.2; Lau, C. P.2; Le Heuzey, J. Y.2; Lewis, B. S.2; Liu, L. L.2; Nanas, J.2; Omar, R.2; Pais, P.2; Pedersen, K. E.3; Piegas, L. S.2; Raev, D.2; Smith, P. J.2; Talajic, M.2; Tan, R. S.2; Tanomsup, S.2; Toivonen, L.2; Vinereanu, D.2; Xavier, D.2; Zhu, J.2; Wang, S. Q.2; Duffy, C. O.2; Themeles, E.2; Yusuf, S.2
1 Cardiology, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU2 unknown3 Cardiology, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU
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: . Unique identifier: NCT00808067.
Circulation (baltimore), 2013, Vol 128, p. 237-243