Objective  To systematically evaluate the efficacy and safety of dronedarone in preventing early recurrence of atrial fibrillation (AF) after ablation.

Methods  PubMed, Web of Science, Cochrane Library, Embase, CNKI, WanFang Data and VIP databases were electronically searched to collect the clinical studies on the efficacy and safety of dronedarone in preventing early recurrence of AF after ablation from the inception to April 16, 2024. Two researchers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was performed by using RevMan 5.3 software.

Results  A total of three randomized controlled trials and eight cohort studies were ultimately included, including 1 534 patients. The results of meta-analysis showed that there was no statistically significant difference in the early recurrence rate of AF after ablation between the dronedarone group and the amiodarone group (RR=1.15, 95%CI 0.90 to 1.47, P=0.25). Compared with the amiodarone group, the dronedarone group had a higher incidence of bleeding (RR=2.28, 95%CI 1.08 to 4.81, P<0.05), a higher incidence of gastrointestinal adverse reactions (RR=3.87, 95%CI 1.39 to 10.74, P=0.009) and a lower incidence of thyroid dysfunction (RR=0.15, 95%CI 0.06 to 0.40, P<0.001). There was no statistically significant difference in the incidence of postoperative bradycardia, liver and kidney dysfunction, and total adverse drug reactions between the two groups (P>0.05). Compared with the propafenone group, the dronedarone group had a lower early recurrence rate of AF after ablation (RR=0.31, 95%CI 0.17 to 0.57, P<0.001). However, there was no statistically significant difference in the incidence of adverse reactions between them (P>0.05).

Conclusion  Current evidence suggests that dronedarone is as effective in preventing early recurrence after AF ablation as amiodarone, but more effective than propafenone. In terms of safety, compared to amiodarone, dronedarone has a lower risk of thyroid dysfunction, but a higher risk of gastrointestinal adverse reactions and bleeding. Due to the limited quality and quantity of the included studies, more large sample, multi-center and high-quality studies are needed to verify the above conclusion.

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