Efficacy and Safety of Dabigatran Compared With Warfarin in Relation to Baseline Renal Function in Patients With Atrial Fibrillation: A RE-LY (Randomized Evaluation of Long-term Anticoagulation Therapy) Trial Analysis

Study Questions:

What are the safety and efficacy of dabigatran compared with warfarin in relation to renal function in patients with atrial fibrillation (AF)?


This was a prespecified analysis of the RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) trial. All randomized patients with available creatinine measurements were included in the statistical analysis (n = 17,951); estimated glomerular filtration rate (eGFR) according to cystatin C level was calculated in a subset of participants with cystatin C available (n = 6,190). Patients were classified according to prespecified values of renal function: no impairment, eGFR ≥80 ml/min; mild impairment, eGFR <50 to <80 ml/min; and moderate to severe impairment, eGFR<50 ml/min.


Rates of stroke or systemic embolism, major bleeding, and all-cause mortality increased as renal function decreased. The rates of stroke or systemic embolism were lower with dabigatran 150 mg and similar with 110 mg twice daily compared with those with warfarin, without significant heterogeneity in subgroups defined by renal function. Dabigatran 110 mg twice daily displayed a lower risk for major bleeding and dabigatran 150 mg twice daily a similar risk compared to warfarin. When GFR was estimated with the Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, a significantly greater relative reduction in major bleeding risk was observed with both dabigatran doses, compared to warfarin.


The authors concluded that dabigatran is efficacious and safe, compared to warfarin, across a range of renal function.


The limitations of this analysis aside, the authors provide useful data that demonstrate that dabigatran can be safe and effective across a wide range of renal function. It should be noted that patients with an eGFR <30 ml/min were excluded from the RE-LY study.

Clinical Topics: Anticoagulation Management

Keywords: Stroke, Warfarin, Glomerular Filtration Rate, Embolism, Creatinine, Renal Insufficiency, Chronic, Cystatin C

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