The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study

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Connolly, Stuart J. (author)

The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study

Article/chapterEnglish2013

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2013
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LIBRIS-ID:oai:DiVA.org:uu-204855
https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-204855URI
https://doi.org/10.1161/CIRCULATIONAHA.112.001139DOI

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Language:English
Summary in:English

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SwePubSwePub

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Subject category:ref swepub-contenttype
Subject category:art swepub-publicationtype

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Clinical Trial Registration URL: Unique identifier: NCT00808067.
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.

Subject headings and genre

atrial fibrillation
dabigatran
hemorrhage
stroke

Added entries (persons, corporate bodies, meetings, titles ...)

Wallentin, LarsUppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi(Swepub:uu)larswall (author)
Ezekowitz, Michael D. (author)
Eikelboom, John (author)
Oldgren, JonasUppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi(Swepub:uu)jonaoldg (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)
Uppsala universitetUppsala kliniska forskningscentrum (UCR) (creator_code:org_t)

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In:Circulation128:3, s. 237-2430009-73221524-4539

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By the author/editor: Connolly, Stuart ...; Wallentin, Lars; Ezekowitz, Micha ...; Eikelboom, John; Oldgren, Jonas; Reilly, Paul A.; show more...; Brueckmann, Mart ...; Pogue, Janice; Alings, Marco; Amerena, John V.; Avezum, Alvaro; Baumgartner, Iri ...; Budaj, Andrzej J ...; Chen, Jyh-Hong; Dans, Antonio L.; Darius, Harald; Di Pasquale, Giu ...; Ferreira, Jorge; Flaker, Greg C.; Flather, Marcus ...; Franzosi, Maria ...; Golitsyn, Sergey ...; Halon, David A.; Heidbuchel, Hein; Hohnloser, Stefa ...; Huber, Kurt; Jansky, Petr; Kamensky, Gabrie ...; Keltai, Matyas; Kim, Sung Soon; Lau, Chu-Pak; Le Heuzey, Jean- ...; Lewis, Basil S.; Liu, Lisheng; Nanas, John; Omar, Razali; Pais, Prem; Pedersen, Knud E ...; Piegas, Leopoldo ...; Raev, Dimitar; Smith, Pal J.; Talajic, Mario; Tan, Ru San; Tanomsup, Supach ...; Toivonen, Lauri; Vinereanu, Drago ...; Xavier, Denis; Zhu, Jun; Wang, Susan Q.; Duffy, Christine ...; Themeles, Elliso ...; Yusuf, Salim; show less...

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