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Randomized Controlled Trial
. 2024 Oct 21;45(40):4305-4314.
doi: 10.1093/eurheartj/ehae532.

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

He Huang  1   2   3 , Yu Liu  1   2   3 , Wei Shuai  1   2   3 , Chenyang Jiang  4 , Menghe Zhang  5 , Xiufen Qu  6 , Wenqing Zheng  7 , Hao Yang  8 , Fan Liu  9 , Bo Yu  10 , Manhua Chen  11 , Bin Mu  12 , Chen Yao  13 , Yanhong Tang  1   2   3 , Congxin Huang  1   2   3 , Feifan Ouyang  14 , Zhenhua Jia  15   16
Affiliations
Randomized Controlled Trial

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

He Huang et al. Eur Heart J. .

Abstract

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, 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.

Conclusions: 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.

Keywords: Catheter ablation; Persistent atrial fibrillation; Shensong Yangxin capsule; Traditional Chinese medicine.

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Figures

Structured Graphical Abstract
Structured Graphical Abstract
A total of 920 Chinese patients with persistent AF undergoing first ablation were randomized to oral SSYX or matched placebo for 12 months. The recurrence of atrial arrhythmia (left), Kaplan–Meier curves depicting the time to the first recurrence of atrial arrhythmia after the 3-month blanking period (middle), and quality of life at 12-month follow-up (right) were evaluated. SSYX, Shensong Yangxin; CI, confidence interval; AF, atrial fibrillation; RD, rate difference; HR, hazard ratio.
Figure 1
Figure 1
Flow diagram illustrating the number of patients in each group throughout the trial
Figure 2
Figure 2
The Sankey diagram displays the proportions of the class I or III anti-arrhythmic drugs used in each group during various follow-up periods after ablation, with thicker branches indicating higher usage rates of the drugs
Figure 3
Figure 3
(A) Bar chart illustrating differences in the first recurrence of atrial arrhythmia from 3 to 12 months of follow-up after catheter ablation between the placebo and the SSYX groups. (B) Kaplan–Meier curves depicting the time to the first recurrence of atrial arrhythmia after the 3-month blanking period in the placebo and the SSYX groups
See this image and copyright information in PMC

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