@article{3109430,
    title = "The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study",
    author = "Connolly, S.J. and Wallentin, L. and Ezekowitz, M.D. and Eikelboom, J. and Oldgren, J. and Reilly, P.A. and Brueckmann, M. and Pogue, J. and Alings, M. and Amerena, J.V. and Avezum, A. and Baumgartner, I. and Budaj, A.J. and Chen, J.-H. and Dans, A.L. and Darius, H. and Di Pasquale, G. and Ferreira, J. and Flaker, G.C. and Flather, M.D. and Franzosi, M.G. and Golitsyn, S.P. and Halon, D.A. and Heidbuchel, H. and Hohnloser, S.H. and Huber, K. and Jansky, P. and Kamensky, G. and Keltai, M. and Kim, S.S. and Lau, C.-P. and Le Heuzey, J.-Y. and Lewis, B.S. and Liu, L. and Nanas, J. and Omar, R. and Pais, P. and Pedersen, K.E. and Piegas, L.S. and Raev, D. and Smith, P.J. and Talajic, M. and Tan, R.S. and Tanomsup, S. and Toivonen, L. and Vinereanu, D. and Xavier, D. and Zhu, J. and Wang, S.Q. and Duffy, C.O. and Themeles, E. and Yusuf, S.",
    journal = "CIRCULATION",
    year = "2013",
    volume = "128",
    number = "3",
    pages = "237-243",
    issn = "0009-7322",
    doi = "10.1161/CIRCULATIONAHA.112.001139",
    keywords = "dabigatran, aged;  alanine aminotransferase blood level;  anticoagulant therapy;  article;  bilirubin blood level;  brain hemorrhage;  cerebrovascular accident;  controlled study;  double blind procedure;  drug dose comparison;  dyspepsia;  embolism;  female;  follow up;  gastrointestinal hemorrhage;  heart atrium fibrillation;  human;  long term care;  major clinical study;  male;  multicenter study;  observational study;  priority journal;  randomized controlled trial;  side effect;  systemic disease, atrial fibrillation;  dabigatran;  hemorrhage;  stroke, Aged;  Aged, 80 and over;  Antithrombins;  Atrial Fibrillation;  Benzimidazoles;  beta-Alanine;  Dose-Response Relationship, Drug;  Embolism;  Female;  Follow-Up Studies;  Hemorrhage;  Hospitalization;  Humans;  Male;  Middle Aged;  Stroke;  Treatment Outcome",
    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. CLINICAL TRIAL REGISTRATION - : URL: http://www.clinicaltrials.gov. Unique identifier: NCT00808067. © 2013 American Heart Association, Inc."
}