Dronedarone Versus Amiodarone for Preventing Atrial Fibrillation Recurrence After Catheter Ablation: A GRADE-Assessed Meta-Analysis of Reconstructed Time-to-Event Data With Trial Sequential Analysis

Abstract

Atrial fibrillation (AF) recurrence remains a major challenge after catheter ablation, and whether dronedarone or amiodarone should be preferred during the post-ablation blanking period is unresolved. We performed a systematic review and meta-analysis comparing these 2 agents after AF catheter ablation. Five single-center Chinese studies (1 open-label randomized trial and 4 retrospective cohorts) enrolling 996 patients (507 dronedarone and 489 amiodarone) were included. In reconstructed individual patient data from 4 studies, AF recurrence did not differ between dronedarone and amiodarone (hazard ratio [HR] 1.06; 95% confidence interval [CI], 0.75-1.50; P = 0.746), confirmed by a 30-day landmark analysis (HR 1.08; 95% CI, 0.75-1.56; P = 0.690), by study-level pooling of HRs (HR 1.06; 95% CI, 0.74-1.52; I2 = 0%), and by restricted mean survival time analysis. Recurrence also did not differ during the blanking period (risk ratio [RR] 1.09; 95% CI, 0.85-1.40) or over long-term follow-up (RR 1.17; 95% CI, 0.89-1.55). Dronedarone was associated with lower risks of QTc-interval prolongation (RR 0.39; 95% CI, 0.19-0.80) and thyroid dysfunction (RR 0.37; 95% CI, 0.24-0.57) but higher risks of gastrointestinal (RR 7.72; 95% CI, 2.10-28.37) and dermatologic (RR 4.20; 95% CI, 1.06-16.53) adverse events. Dronedarone and amiodarone appear equally effective at preventing AF recurrence after catheter ablation but differ in safety, so selection should be individualized according to patient-specific tolerability and toxicity risk.