Abstract 10956: Dabigatran Compared with Warfarin in Patients with Atrial Fibrillation and Symptomatic Heart Failure: A Subgroup Analysis of the RE-LY Trial
Background: Atrial fibrillation (AF) and symptomatic heart failure (sHF) are epidemic and frequently coexist. AF is a predictor of mortality and stroke in patients with HF. HF is a risk factor for bleeding in anticoagulated patients with AF. In the Randomised Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial, there were 4,904 patients with previous symptomatic HF at baseline (i.e. NYHA >2) and 13,203 patients without HF. Goal: To assess the effects of dabigatran etexilate (DE) compared with warfarin in the prespecified subgroup of patients with previous sHF.
Methods: Cox-proportional hazard models including an interaction of treatment by presence of sHF.
Results: The RE-LY trial (n=18,113 patients, median TTR 67.3%) demonstrated that DE was superior (150 mg bid) or non-inferior (110 mg bid) to warfarin for the prevention of stroke/SEE in patients with AF. Annual event rates of stroke/SEE were higher for the sub-group of 4,904 patients with previous sHF at baseline (1.90, 1.44 and 1.92%/y for DE 110, DE 150 and warfarin, repectively) versus 13,203 patients without sHF (1.41, 1.00 and 1.64%/y for DE 110, DE 150 and warfarin, repectively). The superiority of DE 150 mg bid over warfarin and the non-inferiority of DE 110 mg bid remained essentially unchanged for patients with or without sHF: The hazard ratio (HR) for DE 150mg with and without (w/wo) sHF was 0.75 (0.51-1.10) vs. 0.61 (0.47, 0.79): for DE 110mg bid w/wo sHF the HR was 0.99 (0.69-1.42) vs. 0.86 (0.67-1.09); p-value for interaction = 0.66. There were no significant treatment interactions by baseline sHF on major bleeding events: for DE 110mg bid w/wo baseline sHF, HR=0.83 (0.64-1.09) vs. 0.79 (0.67-0.94); for DE 150mg w/wo baseline sHF, HR= 0.79 (0.60-1.03) vs. 0.99 (0.84-1.16), pint =0.21. Rates of ICH were significantly lower for both DE dosages compared with warfarin irrespective of the presence of baseline sHF: for DE 110mg bid w/wo baseline sHF, HR=0.34 (0.14-0.80) vs. 0.28 (0.17-0.47); for DE 150mg w/wo sHF at baseline, HR= 0.39 (0.17-0.89) vs. 0.42 (0.27-0.64), pint = 0.80.
Conclusion: The overall benefits of dabigatran etexilate for stroke/SEE prevention, major bleeding and ICH events relative to warfarin in the RE-LY trial were essentially unchanged in patients with previous sHF.
- © 2011 by American Heart Association, Inc.