• Jorge Ferreira, Michael D Ezekowitz, Stuart J Connolly, Martina Brueckmann, Mandy Fraessdorf, Paul A Reilly, Salim Yusuf, Lars Wallentin, and RE-LY Investigators.
• Hospital Santa Cruz, Lisbon, Portugal. jorge_ferreira@netcabo.pt
• Eur. J. Heart Fail. 2013 Sep 1;15(9):1053-61.

AimsWe evaluated the effects of dabigatran compared with warfarin in the subgroup of patients with previous symptomatic heart failure (HF) in the RE-LY trial.Methods And ResultsRE-LY compared two fixed and blinded doses of dabigatran (110 and 150 mg twice daily) with open-label warfarin in 18 113 patients with AF at increased risk for stroke. Among 4904 patients with HF, annual rates of stroke or systemic embolism (SE) were 1.92% for patients on warfarin compared with 1.90% for dabigatran 110 mg [hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.69-1.42] and 1.44% for dabigatran 150 mg (HR 0.75, 95% CI 0.51-1.10). Annual rates of major bleeding were 3.90% for the group on warfarin, compared with 3.26% for dabigatran 110 mg (HR 0.83, 95% CI 0.64-1.09) and 3.10% for dabigatran 150 mg (HR 0.79, 95% CI 0.60-1.03). Rates of intracranial bleeding were significantly lower for both dabigatran dosages compared with warfarin in patients with HF (dabigatran 110 mg vs. warfarin, HR 0.34, 95% CI 0.14-0.80; dabigatran 150 mg vs. warfarin, HR 0.39, 95% CI 0.17-0.89). The relative effects of dabigatran vs. warfarin on the occurrence of stroke or SE and major bleeding were consistent among those with and without HF and those with low (≤40%) or preserved (>40%) LVEF (P interaction not significant).ConclusionsThe overall benefits of dabigatran for stroke/SE prevention, and major and intracranial bleeding, relative to warfarin in the RE-LY trial were consistent in patients with and without HF.

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