Atrial tachyarrhythmia prevention by Shensong Yangxin after catheter ablation for persistent atrial fibrillation: the SS-AFRF trial

作者：He Huang, Jie Liu, Wei Shuai, Chenyang Jiang, Menghe Zhang, Xiu-fen Qu, Wenqing Zheng, Hao Yang, Fan Liu, Bo Yu, Manhua Chen, Bin Mu, Chen Yao, Yanhong Tang, Congxin Huang, Feifan Ouyang, Zhenhua Jia · 发表于：European Heart Journal · 年份：2024 · DOI：10.1093/eurheartj/ehae532 · 被引用次数：19 · 研究领域：Atrial Fibrillation Management and Outcomes、Cardiac Arrhythmias and Treatments、Cardiac electrophysiology and arrhythmias

BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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,...