Abstract 13190: Efficacy and Safety of Dabigatran Compared With Warfarin in Relation to Baseline Renal Function in Patients With Atrial Fibrillation - a RE-LY Trial Analysis
Background: Renal impairment increases the risk of stroke and bleeding in patients with atrial fibrillation. In the RE-LY trial dabigatran, with approximately 80% renal elimination, displayed superiority over warfarin for prevention of stroke and systemic embolism in the 150 mg dose, and significantly less major bleeding in the 110 mg dose in 18,113 patients with non-valvular atrial fibrillation. This pre-specified study investigates these outcomes in relation to renal function.
Methods and Results: Interaction between renal function and study treatment was evaluated in Cox models for all outcomes. Glomerular filtration rate (GFR) was estimated with the Cockcroft-Gault, CKD-EPI and MDRD equations at baseline in 17,951 participants. A GFR ≥80, 50-<80, and <50 ml/min was estimated in 32.6%, 47.6%, 19.8% based on Cockcroft-Gault, in 21.6%, 59.6%, 18.8% with CKD-EPI, and in 19.6%, 60.4%, 19.9% of the patients based on MDRD, respectively. Rates of stroke or systemic embolism, major bleeding and all-cause mortality increased as renal function decreased. The rates of stroke or systemic embolism was lower with dabigatran 150 mg and similar with 110 mg twice daily, than those with warfarin without significant heterogeneity in subgroups defined by renal function (interaction p>0.1 for all). Both dabigatran doses displayed significantly greater relative reduction in major bleeding rates in patients with GFR ≥80 mL/min using the CKD-EPI and MDRD equations (interaction p≤0.0061).
Conclusions: The efficacy of both dosages of dabigatran was consistent with the overall trial irrespective of renal function. However, both dabigatran doses displayed significantly lower rates of major bleeding in patients with GFR ≥80 ml/min based on the the CKD-EPI and MDRD equations.
- © 2013 by American Heart Association, Inc.