Bleeding Risk in the Early Postoperative Period after Atrial Fibrillation Ablation with Anticoagulant Therapy Using Dabigatran Etexilate

Abstract

The bleeding risk associated with dabigatran etexilate (DABE) dosing remains unclear in patients undergoing catheter ablation for atrial fibrillation (AF) because these patients were excluded from the pivotal clinical trial of DABE. This study aimed to evaluate the bleeding risk factors in patients undergoing catheter ablation for AF with anticoagulant therapy using DABE. A retrospective cohort study included 343 patients who underwent catheter ablation with minimally interrupted DABE dosing (n = 167), where only the morning dose was withheld, or with uninterrupted dosing (n = 176), in adherence to the recommended dose reduction criteria. Bleeding events were assessed for 2 d following catheter ablation. Multivariable logistic regression analysis was performed to identify the bleeding risk factors. Bleeding events were observed in 45 (13.1%) patients. Multivariable analysis revealed that concomitant P-glycoprotein inhibitor use was significantly associated with bleeding events (odds ratio, 2.77; 95% confidence interval, 1.40–5.51; p = 0.004), after adjusting for moderate renal impairment. Among patients with uninterrupted DABE dosing, bleeding events occurred more frequently in concomitant users of P-glycoprotein inhibitors than in non-users (32.4 vs. 9.8%, p = 0.002). However, no significant difference was found among those with minimally interrupted dosing (18.2 vs. 10.4%, p = 0.24). Concomitant P-glycoprotein inhibitor use is a significant bleeding risk factor in patients undergoing catheter ablation with DABE. The increased bleeding risk associated with concomitant P-glycoprotein inhibitor use is more pronounced in patients with uninterrupted DABE dosing. Uninterrupted DABE dosing should be employed cautiously in patients using P-glycoprotein inhibitors.