Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China.
CNS Neurosci Ther. 2018 Oct;24(10):853-862. doi: 10.1111/cns.12980. Epub 2018 May 27.
Previous review from randomized controlled trials (RCT) showed that patients with cryptogenic stroke may benefit from patent foramen ovale (PFO) closure. However, the findings from the systematic review were not clear when observational studies were also included.
We searched MEDLINE, Embase, and Cochrane databases. The primary endpoints were recurrent stroke or transient ischemic attack (TIA). The secondary outcomes were all-cause death, atrial fibrillation (AF), and hemorrhagic events.
Five randomized trials and fourteen observational studies (6301 participants) were eligible. PFO closure was superior to medical therapy for stroke prevention risk ratios ([RR], 0.38; 95% CI, 0.24-0.60), but showed increased risk of AF (RR, 4.96; 95% CI, 2.31-10.7). There was no significant difference in TIA recurrence, death, and hemorrhagic events. Subgroup analyses showed that patients with factors such as substantial residual shunt, the presence of atrial septal aneurysm (ASA), male, and age <45 years had a lower risk of recurrent stroke when PFOs were closed.
In patients with cryptogenic stroke, PFO closure does appeared to be superior to medical therapy in stroke prevention, with an increased incidence of AF. Male, age <45 years, substantial residual shunt, and the history of ASA are the factors that will predict the benefit when PFO is closed.
先前的随机对照试验（RCT）综述显示，隐源性卒中患者可能从卵圆孔未闭（PFO）封堵中获益。然而，当纳入观察性研究时，系统综述的结果并不明确。
我们检索了 MEDLINE、Embase 和 Cochrane 数据库。主要终点是复发性卒中或短暂性脑缺血发作（TIA）。次要结局是全因死亡、心房颤动（AF）和出血事件。
有 5 项随机试验和 14 项观察性研究（6301 名参与者）符合纳入标准。与药物治疗相比，PFO 封堵在预防卒中方面更具优势（风险比 [RR]，0.38；95%可信区间，0.24-0.60），但 AF 风险增加（RR，4.96；95%可信区间，2.31-10.7）。TIA 复发、死亡和出血事件无显著差异。亚组分析显示，在存在大量残余分流、房间隔瘤（ASA）、男性和年龄<45 岁等因素的患者中，PFO 封堵后复发性卒中的风险较低。
在隐源性卒中患者中，PFO 封堵似乎在预防卒中方面优于药物治疗，AF 的发生率增加。男性、年龄<45 岁、大量残余分流和 ASA 病史是 PFO 封堵时预测获益的因素。
