Atrial fibrillation burden and clinical outcomes in catheter ablation vs lifestyle modification: prague-25 sub-analysis

Background/Introduction

PRAGUE-25 trial compared catheter ablation (CA) to lifestyle modification (LFM) in combination with antiarrhythmic drugs (AAD) in patients with atrial fibrillation (AF) and a body mass index (BMI) between 30 and 40 kg/m². AF burden reflects disease severity and treatment effectiveness. Data comparing the effect of LFM on AF burden, especially in comparison with LFM-AAD are limited.

Purpose

This sub-analysis aimed to evaluate 1) AF burden and 2) clinical outcomes between CA and LFM-AAD patients from the PRAGUE-25 study.

Methods

It is per-protocol analysis of clinical outcomes and AF burden in the PRAGUE-25 trial. For the purpose of the present analysis, patients with cross-over were excluded. AF burden was evaluated at 6, 9, and 12 months after randomization. Clinical outcomes included AF-related hospitalizations, emergency visits, and major adverse cardiovascular events (MACE).

Results

From the original population consisting of 203 patients, 24 patients underwent cross-over during the

first year. As such, 96 in the CA group and 83 in the LFM + AAD group were included in per-protocol analysis. Baseline AF burden was comparable between groups (3.2 [IQR 0.0; 98.0] vs 5.8 [IQR 0.0; 100.0], p = 0.39). At each milestone (6, 9, 12 months), both absolute AF burden and ΔAF burden (delta of AF burden at 12 months and baseline) were significantly lower with CA (AF burden at 12 months; 0.0 [IQR 0.0; 0.0] vs. 0.0 [IQR 0.0; 45.5], p= <0.001). AF-related hospitalization or emergency visit occurred in 7 % vs 16.5 % (p = 0.049), while the composite of stroke, cardiovascular death, or heart-failure hospitalization was rare and similar between groups (1 % vs. 1.9 %, p = 0.99).

Conclusion

Catheter ablation achieved superior rhythm control compared with lifestyle modification plus AAD

therapy. The reduction in AF burden was accompanied by fewer AF-related hospitalizations.