Atrial Fibrillation Burden and Clinical Outcomes After Catheter Ablation vs Lifestyle Modification With Antiarrhythmic Drugs.

BACKGROUND: PRAGUE-25 compared catheter ablation (CA) with lifestyle modification combined with antiarrhythmic drugs (LFM + AADs) in obese patients with atrial fibrillation (AF). OBJECTIVES: The objective of the study was to evaluate: 1) AF burden; and 2) clinical outcomes in CA vs LFM + AAD per-protocol populations enrolled in the PRAGUE-25 trial. METHODS: This per-protocol analysis included patients who adhered to the assigned treatment strategy (patients' crossing over between treatment strategies were excluded at the time of crossover). AF burden was assessed by 7-day Holter monitoring at baseline and 6, 9, and 12 months after randomization. Clinical outcomes included AF-related hospitalizations or emergency visits and major adverse cardiovascular events (composite of stroke, cardiovascular death, or heart failure hospitalization) during the study course. RESULTS: Of the 203 randomized patients, 96 CA and 83 LFM + AAD patients were included in the per-protocol analysis. The mean age was 60 ± 9 years, 68.5% were men, and the mean body mass index of 35 ± 3 kg/m2. Baseline AF burden was similar between groups (median [IQR] 3.2% [0.0-98.0] vs 5.8% [0.0-100.0]; P = 0.39). AF burden was lower in the CA group at 6, 9, and 12 months (all P < 0.001). AF-related hospitalizations or emergency visits occurred in 7.0% vs 15.5% (P = 0.026), whereas major adverse cardiovascular events were rare and similar between groups (1.0% vs 1.9%; P = 0.99). CONCLUSIONS: In this per-protocol analysis, CA resulted in superior rhythm control compared with LFM + AAD therapy. AF burden reduction was accompanied by fewer AF-related hospitalizations or emergency visits. (PRAGUE-25 Trial: Catheter Ablation vs. AADs and Risk Factor Modification; NCT04011800).