Pulsed field vs radiofrequency ablation for paroxysmal atrial fibrillation: the BEAT PAROX-AF trial.

Methods

BEAT PAROX-AF is a European, multicentre, open-label, randomized, controlled, superiority trial conducted across nine European sites.

BEAT PAROX-AF 是一项在欧洲九个地点进行的欧洲多中心、开放标签、随机、对照、优效性试验。

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).

符合条件的患者（年龄在18-80岁之间）患有症状性、药物难治性阵发性房颤，按照1:1的比例随机分配到PFA（五瓣叶导管）组或RFA组，遵循CLOSE协议（接触力感应导管和电生理映射系统）。

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.

主要终点是12个月后单次手术的成功率，定义为在2个月的空白期后无≥30秒的房性心律失常复发，无电转复，无I类/III类抗心律失常药物恢复，或无需任何重复消融。

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).

从2021年12月到2024年1月，共有292名患者被随机分配，其中289名（中位年龄63.5岁，58%为男性）被纳入分析（PFA组n=145，RFA组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).

在12个月时，PFA组的单次手术成功率为112/145（77.2%），RFA组为111/143（77.6%）（调整后差异0.9%；95%置信区间-8.2%至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%]).

在经皮射频消融（PFA）患者中，有5例（3.4%）发生了与手术相关的严重不良事件，而在射频消融（RFA）患者中，有11例（7.6%）发生了此类事件（差异为-3.3% [-8.4%, 1.8%]）。

No deaths, persistent phrenic palsy nor stroke occurred.

没有发生死亡、持续的膈神经麻痹或中风事件。

In the RFA group, two patients had pulmonary vein stenosis >70% and 12 > 50%, two tamponades, and one oesophageal bleed.

在射频消融（RFA）组中，有两名患者的肺静脉狭窄程度>70%，另外12名患者狭窄程度>50%，两名患者出现心包填塞，以及一名患者出现食管出血。

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.

这项针对阵发性房颤患者的随机试验未能证明单次射频消融（PFA）与逐点射频消融（RFA）使用CLOSE协议相比，在单次手术中预防房性心律失常方面具有更高的疗效，尽管在这项研究中，使用PFA观察到的安全事件较少。