Safety of catheter ablation compared with antiarrhythmic drugs for atrial fibrillation: A systematic review and meta-analysis of randomized trials.

BACKGROUND: Catheter ablation (CA) is superior to antiarrhythmic drugs (AADs) for maintaining sinus rhythm in atrial fibrillation (AF). However, most randomised controlled trials (RCTs) lack the power to assess CA safety. OBJECTIVE: To evaluate complication rates and relative risks of CA compared with AADs for AF rhythm management. METHODS: MEDLINE, Embase and Cochrane CENTRAL (inception-Oct 24, 2024) were searched for RCTs comparing CA vs. AADs in AF management. The primary endpoint was a composite of serious adverse events (SAE), including death, additional intervention, prolonged or unplanned hospitalisation or disability. Secondary endpoints included SAE components. A random-effects meta-analysis estimated pooled risk ratios (RR) with 95% confidence intervals (CI). RESULTS: Twenty-four randomised trials comprising 6,665 participants were included in the meta-analysis, with 3,554 patients (53.2%) assigned to the catheter ablation group and 3,111 patients (46.7%) to the antiarrhythmic drug group. During a 12-month median follow-up (6-60 months), CA was associated with a 20% lower risk of SAE compared with AAD (RR 0.80, 95% CI 0.69-0.93, I2 0%, p < 0.01) and 47% reduction in risk unplanned hospitalisation (RR 0.53, 95% CI 0.38-0.72, I2 73%, p < 0.01). CA was also associated with a 37% lower risk of adverse cardiovascular events (RR 0.63, 95% CI 0.44-0.90, I2 42%, p = 0.01). CONCLUSIONS: CA for AF rhythm management reduced SAEs, unplanned hospitalisation and adverse cardiovascular events compared with AADs. When patient safety is being considered, AAD appears to have a less favourable safety profile than catheter ablation in AF.