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

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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Journal
EP Europace
Published
2026-09-01
DOI
https://doi.org/10.1093/europace/euag230
Primary Topic
Atrial Fibrillation Management and Outcomes
Type
article
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article

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

Zhongbao Ruan, Wei Yue, 凌天佑, Baopeng Tang et al.
EP Europace
Atrial Fibrillation Management and Outcomes
article

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

Zhongbao Ruan, Wei Yue, 凌天佑, Baopeng Tang, Bing Han, Zhijun Wu, Wei Xu, Suxia Guo, Jingfeng Wang, Tong Liu, Yu Yu, Yazhou Lin, Hong Zhi, Qi Jin, Rui Zeng, Jingquan Zhong, Yangyang Bao, Jiangui He, Jing Xu, Wei Li, Lin Chen, Changjian Lin, Liqun Wu, Kai Tang, Qi Lu, Ning Zhang
article en

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.

EP Europace
Fujian Medical University (CN), Xinjiang Medical University (CN), Sun Yat-sen University (CN), Nantong University (CN), Sichuan University (CN), Ruijin Hospital (CN), First Affiliated Hospital of Xinjiang Medical University (CN), Affiliated Hospital of Nantong University (CN), West China Hospital of Sichuan University (CN), Sun Yat-sen Memorial Hospital (CN), Zhongda Hospital Southeast University (CN), Affiliated Hospital of Guizhou Medical University (CN), Taizhou People's Hospital (CN), Dongguan People’s Hospital (CN), The First Affiliated Hospital, Sun Yat-sen University (CN), Shanghai Tenth People's Hospital (CN), Xuzhou Central Hospital (CN), Second Hospital of Tianjin Medical University (CN), Fujian Provincial Hospital (CN), Tianjin Chest Hospital (CN), Qilu Hospital of Shandong University (CN), Tianjin Medical University (CN), Southern Medical University (CN), Nanjing University (CN)
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Atrial Fibrillation Management and Outcomes
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