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

• Published in: Circulation (New York, N.Y.) Vol. 128; no. 3; pp. 237 - 243
• Main Authors: 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, 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
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD by the American College of Cardiology Foundation and the American Heart Association, Inc 16.07.2013; Lippincott Williams & Wilkins
• Subjects: Aged; Aged, 80 and over; Antithrombins - administration & dosage; Antithrombins - adverse effects; atrial fibrillation; Atrial Fibrillation - drug therapy; Atrial Fibrillation - mortality; Benzimidazoles - administration & dosage; Benzimidazoles - adverse effects; beta-Alanine - administration & dosage; beta-Alanine - adverse effects; beta-Alanine - analogs & derivatives; Dabigatran; Dose-Response Relationship, Drug; Embolism - mortality; Embolism - prevention & control; Female; Follow-Up Studies; hemorrhage; Hemorrhage - chemically induced; Hemorrhage - mortality; Hospitalization - statistics & numerical data; Humans; Male; Middle Aged; stroke; Stroke - mortality; Stroke - prevention & control; Treatment Outcome; dabigatran; atrial fibrillation; stroke; hemorrhage
• ISSN: 0009-7322; 1524-4539; 1524-4539
• DOI: 10.1161/CIRCULATIONAHA.112.001139

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—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00808067.