TY - JOUR
TI - The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study
AU - Connolly, S.J.
AU - Wallentin, L.
AU - Ezekowitz, M.D.
AU - Eikelboom, J.
AU - Oldgren, J.
AU - Reilly, P.A.
AU - Brueckmann, M.
AU - Pogue, J.
AU - Alings, M.
AU - Amerena, J.V.
AU - Avezum, A.
AU - Baumgartner, I.
AU - Budaj, A.J.
AU - Chen, J.-H.
AU - Dans, A.L.
AU - Darius, H.
AU - Di Pasquale, G.
AU - Ferreira, J.
AU - Flaker, G.C.
AU - Flather, M.D.
AU - Franzosi, M.G.
AU - Golitsyn, S.P.
AU - Halon, D.A.
AU - Heidbuchel, H.
AU - Hohnloser, S.H.
AU - Huber, K.
AU - Jansky, P.
AU - Kamensky, G.
AU - Keltai, M.
AU - Kim, S.S.
AU - Lau, C.-P.
AU - Le Heuzey, J.-Y.
AU - Lewis, B.S.
AU - Liu, L.
AU - Nanas, J.
AU - Omar, R.
AU - Pais, P.
AU - Pedersen, K.E.
AU - Piegas, L.S.
AU - Raev, D.
AU - Smith, P.J.
AU - Talajic, M.
AU - Tan, R.S.
AU - Tanomsup, S.
AU - Toivonen, L.
AU - Vinereanu, D.
AU - Xavier, D.
AU - Zhu, J.
AU - Wang, S.Q.
AU - Duffy, C.O.
AU - Themeles, E.
AU - Yusuf, S.
JO - CIRCULATION
PY - 2013
VL - 128
TODO - 3
SP - 237-243
PB - 
SN - 0009-7322
TODO - 10.1161/CIRCULATIONAHA.112.001139
TODO - 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
TODO - 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.
ER -