Key result
Concomitant P-glycoprotein inhibitors linked to ~177% higher bleeding risk post-ablation in patients on dabigatran.
Why the study?
Bleeding risk associated with dabigatran etexilate dosing remains unclear in patients undergoing catheter ablation for AF because they were excluded from the pivotal clinical trial.
Does concomitant P-glycoprotein inhibitor use increase bleeding events in patients undergoing catheter ablation for atrial fibrillation on dabigatran etexilate?
Cohort (n=343)
No
Does concomitant P-glycoprotein inhibitor use increase bleeding events in patients undergoing catheter ablation for atrial fibrillation on dabigatran etexilate?
Effect estimate: OR 2.77 (95% CI 1.40-5.51)
Absolute Event Rate: 25.4% vs 10.1%
p-value: p=0.004
Concomitant P-glycoprotein inhibitor use significantly increases bleeding risk in patients undergoing AF ablation on uninterrupted dabigatran.
Suggests caution with P-gp inhibitors during dabigatran for AF ablation; hypothesis-generating pending prospective trials.
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.
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Takashima et al. (2025) conducted a cohort in Nonvalvular atrial fibrillation (n=343). Concomitant P-glycoprotein inhibitor use vs. No P-glycoprotein inhibitor use was evaluated on First occurrence of any bleeding event during the 2 days after catheter ablation (OR 2.77, 95% CI 1.40-5.51, p=0.004). Concomitant use of P-glycoprotein inhibitors significantly increased the risk of bleeding events (OR 2.77) within 2 days after catheter ablation in patients receiving dabigatran etexilate.
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