Patent Foramen Ovale Closure in Stroke and the PASCAL Classification System.

Careful selection of patients in whom PFO is more likely to be the cause of stroke may improve outcomes by avoiding closure in patients unlikely to benefit.

仔细选择PFO更可能是卒中原因的患者，通过避免在不太可能受益的患者中进行封堵，可能会改善结果。

Background

To determine whether the PFO-Associated Stroke Causal Likelihood (PASCAL) classification system identifies who will experience net benefit and net harm from PFO closure.

确定PFO相关卒中因果可能性（PASCAL）分类系统是否能识别哪些患者将从PFO封堵术中获得净益处和净伤害。

DESIGN, SETTING, AND PARTICIPANTS: This meta-analysiswas a secondary analysis of individual participant-level data from the Systematic, Collaborative, PFO Closure Evaluation (SCOPE) consortium meta-analysis, including all 6 randomized trials of transcatheter PFO closure vs antithrombotic therapy alone.

设计、环境和参与者：这项荟萃分析是对系统性、协作性、PFO封堵评估（SCOPE）联盟荟萃分析的个体参与者级数据的二次分析，包括所有6项经导管PFO封堵术与单独抗血栓治疗的随机试验。

Participants were young and middle-aged adults (mean [SD] age, 45 [10] years) with a PFO and an otherwise cryptogenic stroke.

参与者为年轻的中年成人（平均[标准差]年龄，45[10]岁），他们有房间隔缺损（PFO）和一个不明原因的中风。

The trials were conducted in hospitals in North America, Europe, Australia, Brazil, and South Korea from 2000 to 2017.

这些试验在2000年至2017年期间在北美洲、欧洲、澳大利亚、巴西和韩国的医院进行。

The current analysis, involving all trial participants, was performed from January to August 2025.

当前分析涉及所有试验参与者，从2025年1月至8月进行。

Methods

Transcatheter PFO closure plus antithrombotic therapy vs antithrombotic therapy alone.

经导管PFO封堵术加抗血栓治疗与单独抗血栓治疗的比较。

main_outcomes_and_measures

The primary efficacy end point was recurrent ischemic stroke.

主要疗效终点是复发性缺血性中风。

The primary safety end point was first-ever detection of AF beyond the periprocedural period (>45 days after randomization).

主要安全性终点是首次在围手术期后（随机化后>45天）检测到房颤（AF）。

Results

The 6 trials enrolled 3740 patients (1889 who had PFO closure, 1851 who had medical therapy); 2058 patients (55.0%) were male, and 1682 (45.0%) were female.

这6项试验共招募了3740名患者（1889名接受PFO封堵术，1851名接受药物治疗）；2058名患者（55.0%）为男性，1682名（45.0%）为女性。

Among patients in all 6 trials, PASCAL classified PFO relatedness to the index stroke as probable in 1382 patients (37.0%), possible in 1811 (48.4%), and unlikely in 547 (14.6%); among the 2967 patients in the 4 trials with broad entry criteria, PASCAL classified PFO relatedness as probable in 860 patients (29.0%), possible in 1565 (52.7%), and unlikely in 543 (18.3%).

在所有6项试验的患者中，PASCAL将PFO与首次中风的相关性分类为可能的有1382名患者（37.0%），可能的有1811名（48.4%），不太可能的有547名（14.6%）；在有广泛入选标准的4项试验的2967名患者中，PASCAL将PFO与首次中风的相关性分类为可能的有860名患者（29.0%），可能的有1565名（52.7%），不太可能的有543名（18.3%）。

The reduction in the absolute rate of recurrent ischemic strokes over 5 years was greater than the increase in first-ever detection of AF in the postperiprocedural period as follows: in the probable group, fewer strokes, -2.5% (95% CI, -4.2% to -1.3%) vs more late AF, 1.3% (95% CI, 0.0% to 2.5%), and in the possible group, fewer strokes -3.4% (95% CI, -5.4% to -1.3%) vs more late AF, 1.1% (95% CI, -0.5% to 2.6%).

在5年期间，复发性缺血性中风的绝对率降低超过了围手术期首次发现房颤的增加，具体如下：在可能组中，中风的减少为 -2.5%（95% 置信区间，-4.2% 至 -1.3%），而晚期房颤的增加为 1.3%（95% 置信区间，0.0% 至 2.5%）；在可能组中，中风的减少为 -3.4%（95% 置信区间，-5.4% 至 -1.3%），而晚期房颤的增加为 1.1%（95% 置信区间，-0.5% 至 2.6%）。

Reduction in recurrent ischemic strokes was not observed and increase in first-ever detected postperiprocedural AF was magnified in the unlikely group (more strokes, 0.4%; 95% CI, -4.0% to 4.8%, vs more late AF, 4.6%; 95% CI, 0.3% to 8.9%).

在不太可能的组别中，没有观察到复发性缺血性中风的减少，而围手术期首次检测到的房颤增加更为显著（中风增加 0.4%；95% 置信区间，-4.0% 至 4.8%，与晚期房颤增加 4.6%；95% 置信区间，0.3% 至 8.9%）。

conclusion_and_relevance

Among young and middle-aged patients with PFO and otherwise cryptogenic stroke, the PASCAL classification algorithm distinguished the 4 of every 5 patients in the probable and possible groups with net benefit and the 1 of every 5 patients in the unlikely group with net harm from closure.

在有卵圆孔未闭（PFO）且原因不明的中风年轻和中年患者中，PASCAL分类算法区分了可能和可能组中的每五名患者中的四名，他们从封堵术中获得了净益处，以及不太可能组中的每五名患者中的一名，他们从封堵术中遭受了净伤害。