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Title: The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study
Authors: 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
Population Health Research Institute, Ontario
Akademiska Sjukhuset
Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharma GmbH & Co. KG
Universitat Heidelberg
Amphia Hospital
Deakin University
Instituto Dante Pazzanese de Cardiologia
Swiss Cardiovascular Center, University Hospital Bern
Szpital Grochowski, Warszawa
National Cheng Kung University
University of the Philippines Manila
Vivantes Neukoelln Medical Center
Ospedale Maggiore
Lankenau Institute for Medical Research
Hospital de Santa Cruz, Carnaxide
University of Missouri-Columbia
Royal Brompton Hospital
Istituto di Ricerche Farmacologiche Mario Negri
National Medical Research Center of Cardiology, Moscow
Carmel Medical Center
KU Leuven
Goethe-Universitat Frankfurt am Main
Wiener Krakenanstaltenverbund
Fakultni Nemocnice v Motole
University Hospital in Bratislava
Semmelweis Egyetem
Yonsei University College of Medicine
The University of Hong Kong
Universite Paris Descartes
Fuwai Hospital
University of Athens
Institut Jantung Negara Kuala Lumpur
St. John's Medical College
Odense Universitetshospital
Ministry of Interior
Akershus University Hospital
Institut de Cardiologie de Montreal
National Heart Centre, Singapore
Mahidol University
Helsinki University Hospital
Universitatea de Medicina si Farmacie Carol Davila din Bucuresti
Keywords: Medicine
Issue Date: 16-Jul-2013
Citation: Circulation. Vol.128, No.3 (2013), 237-243
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: Unique identifier: NCT00808067. © 2013 American Heart Association, Inc.
ISSN: 15244539
Appears in Collections:Scopus 2011-2015

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