Pulsed Field Ablation as Initial Therapy for Persistent Atrial Fibrillation.

Whether pulsed field ablation (PFA) may be a preferred initial treatment is unclear.

脉冲场消融（PFA）是否可能是首选的初始治疗方法尚不明确。

Methods

We conducted an international, randomized trial involving patients with previously untreated persistent atrial fibrillation.

我们开展了一项国际随机试验，研究对象为之前未接受治疗的持续性房颤患者。

The patients were randomly assigned in a 2:1 ratio to receive PFA performed with a pentaspline catheter or to receive antiarrhythmic-drug therapy.

患者按2:1的比例随机分配，接受使用五叶螺旋导管进行的PFA治疗，或者接受抗心律失常药物治疗。

An additional group of patients (PFA-assigned) underwent PFA for the analysis of the primary safety end point alone.

另外一组患者（PFA分配组）仅为了分析主要安全性终点而接受了PFA治疗。

All the patients received an insertable cardiac monitor.

所有患者均植入了可植入式心脏监测器。

The primary effectiveness end point was the short-term and long-term success of treatment through 12 months.

主要有效性终点是通过12个月的治疗的短期和长期成功。

Short-term success was defined as procedural success in the PFA group and the absence of ablation during the blanking period (90 days after treatment initiation) in the antiarrhythmic-drug group.

短期成功被定义为PFA组的程序成功和抗心律失常药物组在治疗开始后90天的空白期内无消融。

Long-term success was defined as freedom from recurrence of atrial arrhythmias, repeat ablation, or need for antiarrhythmic drugs from 90 days through 12 months (in the PFA group) and freedom from amiodarone use at any time.

长期成功被定义为从90天到12个月（在PFA组中）无房性心律失常复发、无需重复消融或抗心律失常药物的自由，以及在任何时候无需使用胺碘酮。

The primary safety end point was device- and procedure-related serious adverse events.

主要的安全终点是与器械和程序相关的严重不良事件。

Results

At 12 months, treatment success was observed in 128 of 207 patients (Kaplan-Meier estimate, 56%; 95% confidence interval[CI], 48 to 63) in the PFA group and in 40 of 103 patients (Kaplan-Meier estimate, 30%; 95% CI, 21 to 40) in the antiarrhythmic-drug group (hazard ratiofor composite treatment failure [a lack of short- and long-term success], 0.46; 95% CI, 0.33 to 0.65; P<0.001).

在12个月时，PFA组有128名患者（Kaplan-Meier估计，56%；95%置信区间[CI]，48至63）和抗心律失常药物组有40名患者（Kaplan-Meier估计，30%；95% CI，21至40）观察到治疗成功（复合治疗失败的风险比[缺乏短期和长期成功]，0.46；95% CI，0.33至0.65；P<0.001）。

A primary safety end-point event occurred in 13 of 257 patients (5.1%) in the combined PFA group (both randomized and PFA-assigned groups).

在合并PFA组（包括随机和指定PFA组）的257名患者中，有13名患者（5.1%）发生了主要安全终点事件。

At 12 months, serious adverse events had occurred in 45 patients (25%) in the PFA group and in 20 patients (21%) in the antiarrhythmic-drug group.

在12个月时，PFA组中有45名患者（25%）和抗心律失常药物组中有20名患者（21%）发生了严重不良事件。

Conclusions

Among patients with persistent atrial fibrillation, the risk of recurrence of atrial arrhythmia was significantly lower among those who received PFA as first-line treatment than among those who received antiarrhythmic-drug therapy.

在持续性房颤患者中，接受PFA作为一线治疗的患者复发房性心律失常的风险显著低于接受抗心律失常药物治疗的患者。

(Funded by Boston Scientific; AVANT GUARD ClinicalTrials.gov number, NCT06096337.).

(由波士顿科学公司资助; AVANT GUARD ClinicalTrials.gov编号, NCT06096337。)