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).