Pulsed Field Ablation Versus Sham to Treat Atrial Fibrillation: The PFA-SHAM Randomized Clinical Trial.

Despite the large body of evidence of its effectiveness, with a single exception, prior ablation studies were largely unblinded trials.

尽管有大量证据表明其有效性，但除了一个例外，之前的消融研究大多是非盲法试验。

Accordingly, residual concerns remained about placebo effects, both for AF recurrence and, in particular, on subjective outcomes such as quality of life or anxiety.

因此，关于安慰剂效应的剩余担忧仍然存在，这不仅体现在房颤复发上，特别是在主观结果如生活质量或焦虑上。

Here, we compared pulsed field ablation (PFA) with a sham procedure to treat patients with symptomatic AF.

在这里，我们比较了脉冲场消融（PFA）与假手术治疗有症状房颤患者的效果。

Methods

This prospective, sham-controlled, single-blind, randomized clinical trial with blinded end-point assessment enrolled patients with AF that was highly symptomatic (Atrial Fibrillation Effect on Quality-of-Life score <50).

这是一项前瞻性、安慰剂对照、单盲、随机临床试验，对终点评估进行了盲法评估，招募了症状严重的房颤患者（房颤对生活质量的影响评分<50）。

Patients were assigned 1:1 to PFA or a sham procedure.

患者按1:1的比例被分配到PFA或安慰剂手术。

All participants received implantable cardiac monitors for continuous rhythm monitoring during follow-up.

所有参与者在随访期间接受了可植入式心脏监测器，以进行持续的心律监测。

The 6-month co-primary outcomes were (1) time to first recurrence of atrial tachyarrhythmia and (2) changes from baseline in Atrial Fibrillation Effect on Quality-of-Life scores compared between groups.

6个月的主要共研究结果是：（1）首次房性心动过速复发的时间；（2）与基线相比，两组间房颤对生活质量影响评分的变化。

Secondary outcomes were AF burden and psychological distress (assessed by the Hospital Anxiety and Depression Scale [HADS]).

次要结果是房颤负荷和心理困扰（通过医院焦虑抑郁量表[HADS]评估）。

Results

Patients (n=60) were randomized to PFA or sham.

患者（n=60）被随机分配到PFA或安慰剂组。

At 6 months, the first co-primary end point of AF recurrence was met in 2 patients (6.7%) who underwent PFA and 25 patients (83.3%) who underwent sham (posterior hazard ratio, 19.6 [95% bayesian credible intervals, 6.7-76.9]; posterior probability of superiority >0.99).

在6个月时，首次共同主要终点的房颤复发在2名（6.7%）接受PFA治疗的患者和25名（83.3%）接受安慰剂治疗的患者中得到满足（后验风险比为19.6 [95%贝叶斯可信区间为6.7-76.9]；后验优越性概率>0.99）。

For the second co-primary end point, Atrial Fibrillation Effect on Quality-of-Life scores showed greater improvement from baseline with PFA than sham (improved by 43.9+18.1 points versus 11.3+27.9 points; posterior median difference, 32.6 [95% bayesian credible interval, 20.2-44.9]; posterior probability of superiority >0.99).

对于第二个共同主要终点，房颤对生活质量评分显示，与安慰剂相比，接受PFA治疗的患者从基线开始有更大的改善（改善了43.9+18.1分，而安慰剂组改善了11.3+27.9分；后验中位数差异为32.6 [95%贝叶斯可信区间为20.2-44.9]；后验优越性概率>0.99）。

AF burden at 6 months was significantly lower in the PFA than the sham group (0 [0-0] versus 0.43 [0.04-3.47]; between group median difference, -0.39 [95% credible interval, -2.5 to -0.1], posterior probability of superiority >0.99).

6个月时，PFA组的房颤负荷显著低于假手术组（0 [0-0] 对比 0.43 [0.04-3.47]；组间中位数差异为-0.39 [95%可信区间，-2.5至-0.1]，优势后验概率>0.99）

The Hospital Anxiety and Depression Scale score changed by -4 points (-7.8 to -2.0) with PFA and by -0.5 (-4.5 to 1.0) with sham (group median difference, -3.5 [95% credible interval, -6.0 to -1.0]; posterior probability of superiority >0.99).

使用PFA后，医院焦虑抑郁量表评分变化为-4分（-7.8至-2.0），而假手术组为-0.5分（-4.5至1.0）（组间中位数差异为-3.5 [95%可信区间，-6.0至-1.0]；优势后验概率>0.99）

Conclusions

In patients with AF, PFA was superior to sham in reducing arrhythmia recurrences and burden and improving quality of life and AF-associated psychological distress.

在房颤患者中，PFA在减少心律失常复发和负荷以及改善生活质量和房颤相关心理困扰方面优于安慰剂。

registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT05717725.

网址: https://www.clinicaltrials.gov; 唯一标识符: NCT05717725。