Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2026
Cryoballoon ablation vs. antiarrhythmic drug therapy as initial treatment for persistent atrial fibrillation: the multicentre randomized CEPAF trial.
Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04942834 (Using Cryoballoon Ablation as Initial Treatment for Patients With Persistent Atrial Fibrillation Comparing to Anti-arrhythmic Drugs), which is not on this map. Not yet cited in PubMed.
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Using Cryoballoon Ablation as Initial Treatment for Patients With Persistent Atrial Fibrillation Comparing to Anti-arrhythmic Drugs
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26 authors.
Funding
Abstract
aimsEvidence 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 AND
resultsThis multicentre, 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 s during days 91-365. Secondary endpoints included recurrence during days 1-90 and 1-365, time-to-first recurrence, quality of life, and safety. 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 favoured 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.
conclusionIn selected treatment-naive patients with PersAF, first-line CBA reduced atrial tachyarrhythmia recurrence and improved disease-specific quality of life compared with AAD therapy.
trial registrationClinicalTrials.gov, NCT04942834.
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