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Randomized Controlled Trial
. 2025 Jul 8;86(1):18-28.
doi: 10.1016/j.jacc.2025.04.042.

Catheter Ablation vs Lifestyle Modification With Antiarrhythmic Drugs to Treat Atrial Fibrillation: PRAGUE-25 Trial

Pavel Osmancik  1 , Tomas Roubicek  2 , Stepan Havranek  3 , Jan Chovancik  4 , Veronika Bulkova  5 , Dalibor Herman  6 , Martin Matoulek  3 , Vladimir Tuka  3 , Ivan Ranic  4 , Jana Hozmanova  6 , Marek Hozman  6 , Lucie Znojilova  6 , Adam Latinak  2 , Jan Pidhorodecky  2 , Milan Dusik  3 , Jan Simek  3 , Otakar Jiravsky  4 , Bogna Jiravska-Godula  4 , Frantisek Lehar  5 , Michal Cernosek  5 , Zuzana Hejdukova  6 , Hana Zelinkova  7 , Jiri Jarkovsky  7 , Klara Benesova  7
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Free article
Randomized Controlled Trial

Catheter Ablation vs Lifestyle Modification With Antiarrhythmic Drugs to Treat Atrial Fibrillation: PRAGUE-25 Trial

Pavel Osmancik et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Obesity is an important risk factor for atrial fibrillation (AF). Nonrandomized studies have shown that weight loss and increased physical activity are associated with AF reduction.

Objectives: The goal of this study was to assess whether treatment based on lifestyle modification (LFM; directed weight loss and physical exercise) in combination with antiarrhythmic drugs (AADs) is noninferior to catheter ablation (CA) in patients with AF and obesity.

Methods: In a randomized multicenter noninferiority trial, we enrolled patients with paroxysmal or persistent AF and a body mass index (BMI) of 30-40 kg/m2. Patients were randomized to the CA vs LFM+AAD groups in a 1:1 ratio. Seven-day electrocardiographic Holter recordings were performed every 3 months. The primary endpoint was AF freedom during the 12 months after randomization (ie, absence of any AF episode lasting >30 s; the blanking period was 3 months). Secondary endpoints included AF burden, peak oxygen uptake during cardiopulmonary exercise testing, changes in metabolic parameters, and quality of life as assessed with the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire, all compared between randomization and 12 months.

Results: A total of 212 patients were enrolled and randomized. Nine patients withdrew consent, leaving 203 patients for the final analysis; 100 patients were allocated to the CA group and 103 to the LFM+AAD group (overall age 60 ± 9 years, 31.5% female, BMI 34.9 ± 3.0 kg/m2, 55.7% with paroxysmal AF); the mean follow-up time was 23.5 months. The percentage of patients with AF freedom at 12 months was 73.0% (95% CI: 64.3%-81.7%) in the CA group and 34.6% (95% CI: 25.3%-43.9%) in the LFM+AAD group (Pnoninferiority = 0.99, Psuperiority <0.001). Weight change (-6.4 ± 7.9 kg vs -0.35 ± 4.8 kg; P < 0.001) and decreased HbA1c, were more significant in the LFM+AAD group than in the CA group.

Conclusions: Despite important metabolic improvements associated with LFM, CA was superior to LFM combined with AADs in improving freedom from AF at 1 year in patients with AF and obesity.

Keywords: antiarrhythmic drug; atrial fibrillation; catheter ablation; lifestyle modification; obesity.

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Conflict of interest statement

Funding Support and Author Disclosuresds Supported by Ministry of Health of the Czech Republic, grant nr. NU21-02-00388, and by by the Charles University Research program “Cooperatio – Cardiovascular Science.” The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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