Long-term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial (2013)


Atrial fibrillation requiring long-term anticoagulation

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To evaluate the long-term safety of dabigatran 150 mg twice daily vs. 110 mg twice daily in patients with non-valvular AF

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Trial design

Randomized, phase III safety study; extension of the RE-LY trial (Randomized Evaluation of Long-term anticoagulant therapY), enrolled patients continued to receive the double-blind dabigatran dose received in RE-LY
Active treatment: dabigatran 150 mg p.o. twice daily, for up to 28 months (n=2914)
Control treatment: dabigatran 110 mg p.o. twice daily, for up to 28 months (n=2937)

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Primary endpoint (safety): major bleeding
Secondary endpoints (efficacy): stroke (ischemic or hemorrhagic), systemic embolism, pulmonary embolism, myocardial infarction, deep vein thrombosis, death, net clinical benefit (defined as a composite of the following events: stroke, systemic embolism, pulmonary embolism, acute myocardial infarction, death, or major bleeding)

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Trial participants

5851 patients ≥18 years with atrial fibrillation after participation in the RE-LY trial with randomization to dabigatran further requiring long-term anticoagulation

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Safety outcome: Major bleeding (primary endpoint) occurred at rates of 3.74% per year with dabigatran 150 mg twice daily and 2.99%/y with 110 mg twice daily. Mortality rates were similar for the 2 dabigatran doses: 3.10% and 3.02%/y for 110 mg and 150 mg, respectively
Efficacy outcome: The annual rates of stroke or systemic embolism were 1.46% and 1.60% on dabigatran 150 mg and 110 mg, respectively. The rates of hemorrhagic stroke were similar in the 2 treatment arms and were very low at 0.13%/y with dabigatran 150 mg and 0.14%/y with dabigatran 110 mg. Annual rates of myocardial infarction were also low and similar between the 2 groups at 0.69% vs. 0.72%. The results for the composite of all major ischemic, hemorrhagic, and fatal events (7.36% vs. 6.89%/y) indicate that the 2 doses achieve similar net clinical effects

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During 2.3 years of continued treatment with dabigatran after the RE-LY trial, there was no significant difference in stroke or mortality with dabigatran 150 mg vs. 110 mg twice daily, but there was a higher rate of major and minor bleeding with higher dabigatran dose

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Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S. The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study. Circulation 2013;128:237-243

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Corresponding author

Stuart Connolly, MD, Population Health Research Institute, 237 Barton St, East Hamilton, ON L8L 2X2, Canada, e-mail:

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