Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrillation: InsightPFA Trial.

This trial sought to evaluate the efficacy and safety of nsPFA vs ablation index (AI)-guided radiofrequency ablation (RFA) for symptomatic atrial fibrillation.

该试验旨在评估nsPFA与消融指数（AI）引导的射频消融（RFA）在症状性房颤治疗中的有效性和安全性。

Methods

The InsightPFA trial was a prospective, multicenter, randomized controlled trial. Patients were randomly allocated in a 1:1 ratio to receive either nsPFA or ablation index (AI)-guided RFA for pulmonary vein isolation.

InsightPFA试验是一项前瞻性、多中心、随机对照试验。患者按1:1的比例随机分配，接受nsPFA或消融指数（AI）引导的射频消融（RFA）进行肺静脉隔离。

Participants completed a standardized 12-month follow-up protocol.

参与者完成了标准化的12个月随访方案。

The primary efficacy endpoint was defined as freedom from documented atrial tachyarrhythmia recurrence without the use of class I or III antiarrhythmic drugs.

主要疗效终点被定义为在不使用I类或III类抗心律失常药物的情况下，无明确记录的心房快速心律失常复发。

The safety assessment evaluated death, stroke, transient ischemic attack, procedure- and device-related events, and other adverse outcomes in both groups.

安全性评估评估了两组中的死亡、中风、短暂性脑缺血发作、与程序和设备相关的事件以及其他不良结果。

Secondary efficacy endpoints included acute procedural success and procedural evaluations.

次要疗效终点包括急性手术成功和手术评估。

Results

Among 287 patients from 13 centers in China, 141 nsPFA patients and 142 AI-guided RFA patients completed follow-up.

在中国的13个中心的287名患者中，141名非特异性肺动脉成形术（nsPFA）患者和142名人工智能引导的射频消融（AI-guided RFA）患者完成了随访。

The proportions of conscious sedation use were 89.4% in the nsPFA group and 92.4% in the AI-guided RFA group.

在nsPFA组中，有89.4%的患者使用了意识镇静，在AI引导的RFA组中，这一比例为92.4%。

The primary efficacy endpoint was achieved in 93 (65.5%) patients in the nsPFA group and 93 (64.1%) in the AI-guided RFA group in the full analysis set population (adjusted rate difference: 2.0%; 95% CI: -8.7% to 12.8%; P = 0.0019 for noninferiority), demonstrating that the noninferiority was met.

在全分析集人群中，nsPFA组有93名（65.5%）患者达到了主要疗效终点，AI引导的RFA组也有93名（64.1%）患者达到该终点（调整后的率差：2.0%；95%置信区间：-8.7%至12.8%；P=0.0019，证明非劣效性得到满足），表明非劣效性得到了满足。

The 12-month Kaplan-Meier treatment success rates were 66.7% and 67.4% in the nsPFA and AI-guided RFA groups, respectively (HR in the PFA group: 0.99; 95% CI: 0.66 to 1.48; P = 0.0020 for noninferiority).

12个月Kaplan-Meier治疗成功率在nsPFA组和AI引导的RFA组分别为66.7%和67.4%（PFA组的HR为0.99；95%置信区间：0.66至1.48；P=0.0020，用于非劣效性检验）。

There was no significant difference in the incidenceof procedure-related adverse events between the 2 groups.

两组间与程序相关的不良事件发生率没有显著差异。

Acute procedural success rates were 100% in both groups.

两组的急性程序成功率均为100%。

The nsPFA group demonstrated significantly shorter total procedure time, left atrial dwell time, and ablation time but experienced longer fluoroscopy times and higher radiation exposure doses.

nsPFA组显示出总手术时间、左心房停留时间和消融时间显著缩短，但透视时间和辐射暴露剂量更高。

Conclusions

The nsPFA exhibited noninferior efficacy and comparable safety to AI-guided RFA while obviating the need for general anesthesia.

nsPFA展现了与AI引导的射频消融(RFA)相当的疗效和安全性，同时避免了全身麻醉的需求。

Furthermore, the study revealed that this ablation technique significantly reduced both total procedure time and left atrial dwelling time.

此外，该研究显示这种消融技术显著减少了总的手术时间和左心房停留时间。

(InsightPFA Trial of the LotosPFA Catheter [InsightPFA]; NCT06014996).

(LotosPFA导管的InsightPFA试验[InsightPFA]; NCT06014996).