Relationship between the degree of renal dysfunction and the safety and efficacy outcomes in patients with atrial fibrillation receiving direct oral anticoagulants

Abstract Background The clinical evaluation of a direct oral anticoagulant (DOAC) treatment for atrial fibrillation (AF) patients with renal dysfunction has not been sufficiently studied. This study aimed to evaluate the safety and efficacy of DOACs for patients with a severely impaired renal function. Methods This was a retrospective and observational study in a single center. We enrolled 894 consecutive AF patients who were prescribed DOACs, and divided them into three groups based on their creatinine clearance (CrCl) value: CrCl ≥ 50 mL/min group (n = 634), CrCl 30‐49 mL/min group (n = 207), and CrCl 15‐29 mL/min group (n = 53). We evaluated the occurrence of major bleeding (MB) as the safety outcome and thromboembolic events (TEs) as the efficacy outcome during the follow‐up. Results The incidence of MB in the CrCl 15‐29 mL/min group was significantly higher than in the other groups (CrCl ≥ 50 mL/min group, 0.8/100 person‐years; CrCl 30‐49 mL/min group, 1.2/100 person‐years; CrCl 15‐29 mL/min group, 9.0/100 person‐years, log rank test, P