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

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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.

authors

  • Connolly, Stuart
  • Wallentin, Lars
  • Ezekowitz, Michael D
  • Eikelboom, John
  • Oldgren, Jonas
  • Reilly, Paul A
  • Brueckmann, Martina
  • Pogue, Janice
  • Alings, Marco
  • Amerena, John V
  • Avezum, Alvaro
  • Baumgartner, Iris
  • Budaj, Andrzej J
  • Chen, Jyh-Hong
  • Dans, Antonio L
  • Darius, Harald
  • Di Pasquale, Giuseppe
  • Ferreira, Jorge
  • Flaker, Greg C
  • Flather, Marcus D
  • Franzosi, Maria Grazia
  • Golitsyn, Sergey P
  • Halon, David A
  • Heidbuchel, Hein
  • Hohnloser, Stefan H
  • Huber, Kurt
  • Jansky, Petr
  • Kamensky, Gabriel
  • Keltai, Matyas
  • Kim, Sung Soon
  • Lau, Chu-Pak
  • Le Heuzey, Jean-Yves
  • Lewis, Basil S
  • Liu, Lisheng
  • Nanas, John
  • Omar, Razali
  • Pais, Prem
  • Pedersen, Knud E
  • Piegas, Leopoldo S
  • Raev, Dimitar
  • Smith, Pal J
  • Talajic, Mario
  • Tan, Ru San
  • Tanomsup, Supachai
  • Toivonen, Lauri
  • Vinereanu, Dragos
  • Xavier, Denis
  • Zhu, Jun
  • Wang, Susan Q
  • Duffy, Christine O
  • Themeles, Ellison
  • Yusuf, Salim

publication date

  • July 16, 2013

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