Publication:
The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study

Issued Date

2013-07-16

Resource Type

Article

ISSN

15244539
00097322

DOI

10.1161/CIRCULATIONAHA.112.001139

Other identifier(s)

2-s2.0-84880370076

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Circulation. Vol.128, No.3 (2013), 237-243

Suggested Citation

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 The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study. Circulation. Vol.128, No.3 (2013), 237-243. doi:10.1161/CIRCULATIONAHA.112.001139 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/32258

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Title

The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study

Author(s)

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

Other Contributor(s)

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

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.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/32258

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