决奈达隆与胺碘酮联合利伐沙班用于房颤射频消融术后安全性及有效性的临床研究

Clinical Study on the Safety and Efficacy of Dronedarone Combined with Amiodarone and Rivaroxaban for Atrial Fibrillation after Radiofrequency Ablation

摘要: 目的：前瞻性分析决奈达隆联合利伐沙班与胺碘酮联合利伐沙班用于非瓣膜性心房颤动(AF)患者射频导管消融术(CA)后的安全性与有效性。方法：纳入600例首次接受CA治疗的非瓣膜性AF患者，随机分入决奈达隆联合利伐沙班组(D-R组)与胺碘酮联合利伐沙班组(A-R组)，每组300例，各抽取80例监测利伐沙班血药浓度，对比出血事件、器官不良反应、AF空白期(术后3个月内)与远期(术后3~6个月)复发率及房颤负荷。结果 两组CRNMB (临床相关性非大出血)发生率接近(6.7% vs. 4.9%)，均无大出血；监测子组利伐沙班谷、峰浓度无显著差异(P均 > 0.05)。A-R组甲状腺相关异常(11.9% vs. 1.4%)及肺部不良反应(1.1% vs. 0%)发生率显著高于D-R组(P均 < 0.05)。两组空白期复发率(23.4% vs. 22.1%)、远期复发率(12.4% vs. 11.6%)及房颤负荷[3.8% ± 1.5% vs. 3.6% ± 1.4%]无统计学差异(P均 > 0.05)。结论：决奈达隆联合利伐沙班与胺碘酮联合利伐沙班疗效相当，且在甲状腺及肺部安全性上更具优势，可作为CA术后个体化用药优选方案。

Abstract: Objective: To prospectively analyze the safety and efficacy of dronedarone combined with amiodarone and rivaroxaban in patients with non-valvular atrial fibrillation (AF) following radiofrequency catheter ablation (CA). Methods: A total of 600 patients with non-valvular AF undergoing CA for the first time were enrolled and randomly assigned to either the dronedarone plus rivaroxaban group (D-R group) or the amiodarone plus rivaroxaban group (A-R group), with 300 patients in each group. Among them, 80 patients from each group were selected to monitor rivaroxaban plasma concentrations. The incidences of bleeding events, organ-related adverse reactions, AF recurrence during the blanking period (within 3 months post-CA) and the long-term period (3~6 months post-CA), as well as atrial fibrillation burden, were compared. Results: The incidence of clinically relevant non-major bleeding (CRNMB) was comparable between the two groups (6.7% vs. 4.9%), with no major bleeding events reported. In the monitored subgroups, the trough and peak concentrations of rivaroxaban showed no significant difference (all P > 0.05). The A-R group had significantly higher incidences of thyroid-related abnormalities (11.9% vs. 1.4%) and pulmonary adverse reactions (1.1% vs. 0%) compared to the D-R group (all P < 0.05). There were no statistically significant differences between the two groups in blanking period recurrence rates (23.4% vs. 22.1%), long-term recurrence rates (12.4% vs. 11.6%), or atrial fibrillation burden [3.8% ± 1.5% vs. 3.6% ± 1.4%] (all P > 0.05). Conclusion: Dronedarone combined with rivaroxaban demonstrated comparable efficacy to amiodarone combined with rivaroxaban while offering advantages in thyroid and pulmonary safety, making it a preferred option for individualized treatment after CA.