Cryoballoon ablation versus antiarrhythmic drug therapy as initial treatment for persistent atrial fibrillation: the multicenter randomized CEPAF trial

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ID: 327028
2026
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Abstract
BACKGROUND AND AIMS: Evidence supporting first-line cryoballoon ablation (CBA) in treatment-naive persistent atrial fibrillation (PersAF) is limited. Consequently, we compared CBA with guideline-directed antiarrhythmic drug (AAD) therapy in this advanced form of disease. METHODS: This multicenter, prospective, randomized, open-label trial assigned 320 symptomatic, treatment-naive patients with PersAF (1:1) to CBA or AAD therapy. The primary endpoint was the first documented atrial tachyarrhythmia recurrence lasting at least 30 seconds during days 91-365. Secondary endpoints included recurrence during days 1-90 and 1-365, time-to-first recurrence, quality of life, and safety. RESULTS: In the intention-to-treat population, recurrence during days 91-365 occurred in 30/160 (18.8%) patients assigned to CBA and 71/160 (44.4%) assigned to AAD therapy (absolute difference, -25.6 percentage points; 95% confidence interval, -35.4 to -15.8; P<0.001). Supportive time-to-event analysis favored CBA (hazard ratio for AAD vs. CBA, 2.29; 95% confidence interval, 1.48-3.56; log-rank P<0.001). In CBA vs AAD comparisons, overall recurrence during days 1-365 was 23.8% vs. 55.6%, and early recurrence was 11.2% vs. 28.1% (both P<0.001; respectively). Improvement in AFEQT score was greater with CBA (17.3 vs. 6.6 points; P<0.001); whereas SF-12 component scores did not differ significantly. Adverse events recorded on event forms were infrequent in both cohorts. CONCLUSION: In selected treatment-naive patients with PersAF, first-line CBA reduced atrial tachyarrhythmia recurrence and improved disease-specific quality of life compared with AAD therapy.
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Authors 凌天佑, Yazhou Lin, Yangyang Bao, Lin Chen, Wei Xu, Baopeng Tang, Jing Xu, Jingquan Zhong, Wei Li, Zhongbao Ruan, Qi Lu, Suxia Guo, Jingfeng Wang, Bing Han, Kai Tang, Tong Liu, Rui Zeng, Jiangui He, Hong Zhi, Changjian Lin, Wei Yue, Zhijun Wu, Ning Zhang, Qi Jin, Yu Yu, Liqun Wu
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Journal EP Europace
Year 2026
DOI
10.1093/europace/euag230
URL
https://doi.org/10.1093/europace/euag230
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