ACTION Study Group, INSERM UMRS_1166 Institut de Cardiologie (AP-HP), Sorbonne Université, Paris, France.
Québec Heart and Lung Institute, Laval University, Québec City, Québec, Canada.
Can J Cardiol. 2022 Aug;38(8):1228-1234. doi: 10.1016/j.cjca.2022.03.018. Epub 2022 Mar 31.
Randomised controlled trials evaluating percutaneous closure of patent foramen ovale (PFO) have included only patients with a recent embolic event. We aimed to evaluate outcomes after percutaneous PFO closure according to the delay from the last embolic episode.
This international ambispective cohort included consecutive patients from 2 centres in France and Canada undergoing PFO closure for secondary prevention of a paradoxical embolic event. The primary end point was the composite of stroke or transient ischemic attack (TIA). A logistic regression model was used to evaluate determinants of late PFO closure procedures.
A total of 1179 patients (mean age 49 ± 12.7 years; 44.4% female) underwent PFO closure from 2001 to 2021. The median delay from last embolic event to procedure was 6.0 (interquartile range 3.4-11.2) months. The determinants of late PFO closure procedure were the centre (France vs Canada; adjusted odds ratio [aOR] 1.65, 95% confidence interval [CI] 1.25-2.19), year of procedure (since 2018 vs before 2018; aOR 1.43, 95% CI 1.08-1.90), female sex (aOR 1.63, 95% CI 1.28-2.07), and lower risk of paradoxical embolism score (aOR 1.10, 95% CI 1.03-1.19). After a median follow-up of 2.61 (1.13-7.25) years, the incidence rate of first stroke or TIA did not differ between early and late PFO procedures, with 0.51 vs 0.29 events per 100 patient-years, respectively (incidence rate ratio 1.74, 95% CI 0.66-5.08; P = 0.24), and the timing of PFO closure was not associated with the occurrence of stroke or TIA in univariate analysis (hazard ratio 0.54, 95% CI 0.22-1.34) for late vs early closure).
This analysis provides indirect evidence that the delay from the last ischemic event does not affect outcomes after PFO closure for secondary prevention.
评估经皮卵圆孔未闭（PFO）封堵术疗效的随机对照试验仅纳入了近期发生栓塞事件的患者。本研究旨在根据最后一次栓塞事件与介入治疗的时间间隔，评估经皮 PFO 封堵术的预后。
本国际前瞻性队列研究纳入了来自法国和加拿大 2 个中心的连续患者，这些患者因预防反常栓塞事件而接受 PFO 封堵术。主要终点是卒中或短暂性脑缺血发作（TIA）的复合终点。采用逻辑回归模型评估晚期 PFO 封堵术的决定因素。
2001 年至 2021 年期间，共有 1179 例患者（平均年龄 49±12.7 岁，44.4%为女性）接受了 PFO 封堵术。最后一次栓塞事件与介入治疗的时间间隔中位数为 6.0（四分位距 3.4-11.2）个月。晚期 PFO 封堵术的决定因素包括中心（法国与加拿大；校正优势比[OR]1.65，95%置信区间[CI]1.25-2.19）、手术年份（2018 年后与 2018 年前；OR 1.43，95%CI 1.08-1.90）、女性（OR 1.63，95%CI 1.28-2.07）和反常栓塞风险评分较低（OR 1.10，95%CI 1.03-1.19）。中位随访 2.61（1.13-7.25）年后，早期与晚期 PFO 封堵术的首次卒中或 TIA 发生率无差异，分别为 0.51 和 0.29 例/100 患者年（发生率比 1.74，95%CI 0.66-5.08；P=0.24），且单因素分析时封堵术时间与卒中或 TIA 发生无关（晚期与早期封堵术的风险比 0.54，95%CI 0.22-1.34）。
本分析提供了间接证据，表明最后一次缺血事件与 PFO 封堵术治疗二级预防后的预后无关。
