• Media type: E-Article
  • Title: The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study
  • Contributor: Connolly, Stuart J.; 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; [...]
  • Published: Ovid Technologies (Wolters Kluwer Health), 2013
  • Published in: Circulation, 128 (2013) 3, Seite 237-243
  • Language: English
  • DOI: 10.1161/circulationaha.112.001139
  • ISSN: 0009-7322; 1524-4539
  • Origination:
  • Footnote:
  • Description: 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.
  • Access State: Open Access