Stuart J. ConnollyLars WallentinMichael D. EzekowitzJohn EikelboomJonas OldgrenPaul A. ReillyMartina BrueckmannJanice PogueMarco AlingsJohn V. AmerenaAlvaro AvezumIris BaumgartnerAndrzej J. BudajJyh Hong ChenAntonio L. DansHarald DariusGiuseppe Di PasqualeJorge FerreiraGreg C. FlakerMarcus D. FlatherMaria Grazia FranzosiSergey P. GolitsynDavid A. HalonHein HeidbuchelStefan H. HohnloserKurt HuberPetr JanskyGabriel KamenskyMatyas KeltaiSung Soon KimChu Pak LauJean Yves Le HeuzeyBasil S. LewisLisheng LiuJohn NanasRazali OmarPrem PaisKnud E. PedersenLeopoldo S. PiegasDimitar RaevPal J. SmithMario TalajicRu San TanSupachai TanomsupLauri ToivonenDragos VinereanuDenis XavierJun ZhuSusan Q. WangChristine O. DuffyEllison ThemelesSalim YusufPopulation Health Research Institute, OntarioAkademiska SjukhusetBoehringer Ingelheim Pharmaceuticals, Inc.Boehringer Ingelheim Pharma GmbH & Co. KGUniversitat HeidelbergAmphia HospitalDeakin UniversityInstituto Dante Pazzanese de CardiologiaSwiss Cardiovascular Center, University Hospital BernSzpital Grochowski, WarszawaNational Cheng Kung UniversityUniversity of the Philippines ManilaVivantes Neukoelln Medical CenterOspedale MaggioreLankenau Institute for Medical ResearchHospital de Santa Cruz, CarnaxideUniversity of Missouri-ColumbiaRoyal Brompton HospitalIstituto di Ricerche Farmacologiche Mario NegriNational Medical Research Center of Cardiology, MoscowCarmel Medical CenterKU LeuvenGoethe-Universitat Frankfurt am MainWiener KrakenanstaltenverbundFakultni Nemocnice v MotoleUniversity Hospital in BratislavaSemmelweis EgyetemYonsei University College of MedicineThe University of Hong KongUniversite Paris DescartesFuwai HospitalUniversity of AthensInstitut Jantung Negara Kuala LumpurSt. John's Medical CollegeOdense UniversitetshospitalMinistry of InteriorAkershus University HospitalInstitut de Cardiologie de MontrealNational Heart Centre, SingaporeMahidol UniversityHelsinki University HospitalUniversitatea de Medicina si Farmacie Carol Davila din Bucuresti2018-10-192018-10-192013-07-16Circulation. Vol.128, No.3 (2013), 237-24315244539000973222-s2.0-84880370076https://repository.li.mahidol.ac.th/handle/20.500.14594/32258BACKGROUND - : 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.Mahidol UniversityMedicineArticleSCOPUS10.1161/CIRCULATIONAHA.112.001139