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The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study
- Connolly, Stuart J. (author)
-
- Wallentin, Lars (author)
- Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi
- Ezekowitz, Michael D. (author)
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- Eikelboom, John (author)
- Reilly, Paul A. (author)
- Brueckmann, Martina (author)
- Pogue, Janice (author)
- Alings, Marco (author)
- Amerena, John V. (author)
- Avezum, Alvaro (author)
- Baumgartner, Iris (author)
- Budaj, Andrzej J. (author)
- Chen, Jyh-Hong (author)
- Dans, Antonio L. (author)
- Darius, Harald (author)
- Di Pasquale, Giuseppe (author)
- Ferreira, Jorge (author)
- Flaker, Greg C. (author)
- Flather, Marcus D. (author)
- Franzosi, Maria Grazia (author)
- Golitsyn, Sergey P. (author)
- Halon, David A. (author)
- Heidbuchel, Hein (author)
- Hohnloser, Stefan H. (author)
- Huber, Kurt (author)
- Jansky, Petr (author)
- Kamensky, Gabriel (author)
- Keltai, Matyas (author)
- Kim, Sung Soon (author)
- Lau, Chu-Pak (author)
- Le Heuzey, Jean-Yves (author)
- Lewis, Basil S. (author)
- Liu, Lisheng (author)
- Nanas, John (author)
- Omar, Razali (author)
- Pais, Prem (author)
- Pedersen, Knud E. (author)
- Piegas, Leopoldo S. (author)
- Raev, Dimitar (author)
- Smith, Pal J. (author)
- Talajic, Mario (author)
- Tan, Ru San (author)
- Tanomsup, Supachai (author)
- Toivonen, Lauri (author)
- Vinereanu, Dragos (author)
- Xavier, Denis (author)
- Zhu, Jun (author)
- Wang, Susan Q. (author)
- Duffy, Christine O. (author)
- Themeles, Ellison (author)
- Yusuf, Salim (author)
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- (creator_code:org_t)
- 2013
- 2013
- English.
- In: Circulation. - 0009-7322 .- 1524-4539. ; 128:3, s. 237-243
- Journal article (peer-reviewed)
Abstract
Subject headings
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- 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.
Keyword
- atrial fibrillation
- dabigatran
- hemorrhage
- stroke
Publication and Content Type
- ref (subject category)
- art (subject category)
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- Circulation
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