European heart journal · 2026
Pulsed field vs radiofrequency ablation for paroxysmal atrial fibrillation: the BEAT PAROX-AF trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеEquivalence TrialСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Jais Pierre, Neuzil Petr, Scherr Daniel, Frison Eric, Knecht Sebastien, Boveda Serge, Deisenhofer Isabel, Maury Philippe, Deneke Thomas, Cochet Hubert, Rousset Marine, Renaudeau Valentine, Sauer Elena, Sermesant Maxime, Kautzner Josef, Erhard Nico, Wichterle Dan
Аннотация
BACKGROUND AND AIMS: This trial compared single-procedure efficacy and safety of pulsed field ablation (PFA) vs radiofrequency ablation (RFA) in patients with drug-resistant paroxysmal atrial fibrillation (AF).
METHODS: BEAT PAROX-AF is a European, multicentre, open-label, randomized, controlled, superiority trial conducted across nine European sites. Eligible patients (aged 18-80 years) with symptomatic, drug-resistant paroxysmal AF were randomized (1:1) to either PFA (pentaspline) or RFA following the CLOSE protocol (contact force sensing catheter and electro-anatomical mapping system). The primary endpoint was the single-procedure success rate after 12 months defined as the absence of ≥30 s atrial arrhythmia recurrence, cardioversion, class I/III antiarrhythmic drug resumption after a 2-month blanking period, or any repeat ablation.
RESULTS: From December 2021 to January 2024, 292 patients were randomized and 289 (median age 63.5 years, 58% male) were analysed (PFA n = 145, RFA n = 144). Single-procedure success at 12 months was 112/145 (77.2%) in the PFA group and 111/143 (77.6%) in the RFA group (adjusted difference 0.9%; 95% confidence interval -8.2% to 10.1%; P = .84). Procedure-related serious adverse events occurred in 5 (3.4%) PFA vs 11 (7.6%) RFA patients (difference -3.3% [-8.4%, 1.8%]). No deaths, persistent phrenic palsy nor stroke occurred. In the RFA group, two patients had pulmonary vein stenosis >70% and 12 > 50%, two tamponades, and one oesophageal bleed.
CONCLUSIONS: This randomized trial performed in patients with paroxysmal AF did not demonstrate superior efficacy of single-shot PFA vs point-by-point RFA using the CLOSE protocol regarding single-procedure freedom from atrial arrhythmias, despite fewer safety events being observed in this study with PFA.
METHODS: BEAT PAROX-AF is a European, multicentre, open-label, randomized, controlled, superiority trial conducted across nine European sites. Eligible patients (aged 18-80 years) with symptomatic, drug-resistant paroxysmal AF were randomized (1:1) to either PFA (pentaspline) or RFA following the CLOSE protocol (contact force sensing catheter and electro-anatomical mapping system). The primary endpoint was the single-procedure success rate after 12 months defined as the absence of ≥30 s atrial arrhythmia recurrence, cardioversion, class I/III antiarrhythmic drug resumption after a 2-month blanking period, or any repeat ablation.
RESULTS: From December 2021 to January 2024, 292 patients were randomized and 289 (median age 63.5 years, 58% male) were analysed (PFA n = 145, RFA n = 144). Single-procedure success at 12 months was 112/145 (77.2%) in the PFA group and 111/143 (77.6%) in the RFA group (adjusted difference 0.9%; 95% confidence interval -8.2% to 10.1%; P = .84). Procedure-related serious adverse events occurred in 5 (3.4%) PFA vs 11 (7.6%) RFA patients (difference -3.3% [-8.4%, 1.8%]). No deaths, persistent phrenic palsy nor stroke occurred. In the RFA group, two patients had pulmonary vein stenosis >70% and 12 > 50%, two tamponades, and one oesophageal bleed.
CONCLUSIONS: This randomized trial performed in patients with paroxysmal AF did not demonstrate superior efficacy of single-shot PFA vs point-by-point RFA using the CLOSE protocol regarding single-procedure freedom from atrial arrhythmias, despite fewer safety events being observed in this study with PFA.