Cryoballoon ablation vs. antiarrhythmic drug therapy as initial treatment for persistent atrial fibrillation: the multicentre randomized CEPAF trial.

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 AND

RESULTS

This 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.

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.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT04942834.