Lattanzi Simona, Brigo Francesco, Cagnetti Claudia, Di Napoli Mario, Silvestrini Mauro
Department of Experimental and Clinical Medicine, Neurological Clinic, Marche Polytechnic University, Ancona, Italy.
Department of Neuroscience, Biomedicine and Movement Science, University of Verona, Verona, Italy.
Cerebrovasc Dis. 2018;45(5-6):193-203. doi: 10.1159/000488401. Epub 2018 Apr 12.
The optimal strategy of secondary stroke prevention in patients with patent foramen ovale (PFO) is controversial. This study was performed to evaluate the efficacy and safety of the device closure (DC) versus the medical therapy (MT) in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO.
Randomized controlled trials with active and control groups receiving the DC plus MT and MT alone in patients with history of cryptogenic stroke/TIA and diagnosis of PFO were systematically searched. The main efficacy outcome was stroke recurrence. Subgroup-analyses were performed according to age, shunt size, and presence of atrial septal aneurysm (ASA). Safety endpoints included any serious adverse event (SAE), atrial fibrillation (AF), and major bleeding complications. Risk ratios (RRs) and hazard ratios (HRs) with 95% CIs were estimated. Five trials were included, involving 3,440 participants (DC = 1,829, MT = 1,611). There was a protective effect of closure in the risk of recurrent stroke (RR 0.43 [0.21-0.90]; p = 0.024; HR = 0.39 [0.19-0.83]; p = 0.014). The benefit of PFO closure was significant in patients with PFO associated with substantial right-to-left shunt or ASA. There were no differences in the risks of SAEs and major bleedings between the groups. The rate of new-onset AF was higher in the DC than in the MT arm (RR 4.46 [2.35-8.41]; p < 0.001). Successful device implantation and effective PFO closure were achieved in 96 and 91% of the patients respectively. Key Messages: In selected adult patients with PFO and history of cryptogenic stroke, the DC plus MT is more effective to prevent stroke recurrence and is associated with an increased risk of new-onset AF compared to the MT alone.
卵圆孔未闭（PFO）患者二级卒中预防的最佳策略存在争议。本研究旨在评估封堵器封堵（DC）与药物治疗（MT）对不明原因卒中或短暂性脑缺血发作（TIA）合并PFO患者的疗效和安全性。
系统检索了随机对照试验，试验中，有不明原因卒中/TIA病史且诊断为PFO的患者被分为积极治疗组和对照组，分别接受DC联合MT以及单纯MT治疗。主要疗效指标为卒中复发。根据年龄、分流大小和房间隔瘤（ASA）的存在情况进行亚组分析。安全终点包括任何严重不良事件（SAE）、心房颤动（AF）和严重出血并发症。估计风险比（RRs）和风险比（HRs）及95%置信区间。纳入了5项试验，涉及3440名参与者（DC组 = 1829人，MT组 = 1611人）。封堵对复发性卒中风险有保护作用（RR 0.43 [0.21 - 0.90]；p = 0.024；HR = 0.39 [0.19 - 0.83]；p = 0.014）。PFO封堵对合并大量右向左分流或ASA的PFO患者的益处显著。两组之间SAE和严重出血的风险没有差异。DC组新发AF的发生率高于MT组（RR 4.46 [2.35 - 8.41]；p < 0.001）。分别有96%和91%的患者成功植入装置并有效封堵PFO。关键信息：在选定的有PFO和不明原因卒中病史的成年患者中，与单纯MT相比，DC联合MT预防卒中复发更有效，且新发AF的风险增加。
