Department of Cardiology, Renmin Hospital of Wuhan University, 238 Jiefang Road, Wuhan 430060, China.
Cardiovascular Research Institute of Wuhan University, 238 Jiefang Road, Wuhan 430060, China.
Eur Heart J. 2024 Oct 21;45(40):4305-4314. doi: 10.1093/eurheartj/ehae532.
Despite advances in technology and techniques, the recurrence rate of persistent atrial fibrillation (AF) following catheter ablation remains high. The Shensong Yangxin (SSYX) capsule, a renowned traditional Chinese medicine formula, is used in the treatment of cardiac arrhythmias. This trial aimed to investigate whether the SSYX can improve clinical outcomes in patients who have undergone catheter ablation for persistent AF.
A multi-centre, randomized, double-blind, placebo-controlled clinical trial was conducted at 66 centres in China among 920 patients with persistent AF undergoing first ablation. Participants were randomized to oral SSYX, 1.6 g (.4 g/granule) thrice daily (n = 460), or matched placebo (n = 460) for 12 months. The primary endpoint was recurrent atrial tachyarrhythmias lasting for ≥30 s following a blanking period of 3 months. Secondary endpoints included time to first documented atrial tachyarrhythmias, AF burden, cardioversion, stroke/systemic embolism, changes in echocardiographic parameters, and quality-of-life (QoL) score. Analyses were performed according to the intention-to-treat principle.
A total of 920 patients underwent randomization (460 assigned to SSYX group and 460 assigned to placebo group). During the follow-up of 12 months, patients assigned to SSYX had a higher event-free rate from recurrent atrial tachyarrhythmias when compared with the placebo group (12-month Kaplan-Meier event-free rate estimates, 85.5% and 77.7%, respectively; hazard ratio, .6; 95% confidence interval .4-.8; P = .001). Patients assigned to receive SSYX had a better QoL score at 12 months compared to those randomized to placebo. There was no significant difference in the incidence of serious adverse events between the two groups.
Treatment with SSYX following radiofrequency catheter ablation for persistent AF reduced the incidence of recurrent atrial tachyarrhythmias and led to clinically significant improvements in QoL during a 12-month follow-up in a Chinese population.
尽管技术和技术有所进步，但导管消融后持续性心房颤动（AF）的复发率仍然很高。参松养心胶囊是一种著名的中药配方，用于治疗心律失常。本试验旨在研究参松养心胶囊是否可以改善接受持续性 AF 导管消融的患者的临床结局。
在中国 66 个中心进行了一项多中心、随机、双盲、安慰剂对照的临床试验，共有 920 例持续性 AF 患者接受首次消融。参与者随机分为口服参松养心胶囊，每日 3 次，每次 1.6 克（4 克/粒）（n=460）或匹配的安慰剂（n=460），疗程为 12 个月。主要终点是在 3 个月空白期后持续≥30 秒的复发性房性心动过速。次要终点包括首次记录到的房性心动过速、AF 负荷、电复律、卒中和全身性栓塞、超声心动图参数变化以及生活质量（QoL）评分的变化。分析按照意向治疗原则进行。
共 920 例患者接受随机分组（460 例分配到参松养心胶囊组，460 例分配到安慰剂组）。在 12 个月的随访期间，与安慰剂组相比，接受参松养心胶囊治疗的患者复发性房性心动过速的无事件率更高（12 个月 Kaplan-Meier 无事件率估计值分别为 85.5%和 77.7%；风险比，0.6；95%置信区间，0.4-0.8；P=0.001）。与随机分配到安慰剂的患者相比，接受参松养心胶囊治疗的患者在 12 个月时的 QoL 评分更好。两组严重不良事件的发生率无显著差异。
在中国人群中，射频导管消融治疗持续性 AF 后使用参松养心胶囊可降低复发性房性心动过速的发生率，并在 12 个月的随访中导致 QoL 有临床意义的改善。
