Universität des Saarlandes, Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Kirrberger Strasse, 66421, Homburg, Germany.
Clin Res Cardiol. 2019 Feb;108(2):157-166. doi: 10.1007/s00392-018-1334-z. Epub 2018 Jul 26.
We aimed to explore whether interventional closure of patent foramen ovale (PFO) results in reduction of composite outcome [stroke/transitory ischemic attack (TIA), death, and thrombolysis in myocardial infarction-TIMI bleeding], stroke and stroke/TIA compared to medical treatment in patients with cryptogenic stroke.
Searching the PUBMED and Cochrane library database, we performed meta-analysis from all randomized controlled studies that compared effects of interventional PFO closure with medical treatment on stroke prevention. 3560 patients from six randomized trials were included. Interventional PFO closure reduced composite outcome (RR of 0.47, 0.26-0.85, p = 0.01), stroke (RR of 0.38, 0.18-0.82, p = 0.01) and stroke/TIA (RR of 0.56, 0.43-0.74, p < 0.0001). Analysis had 70.5% power to detect observed reduction of RR for the primary outcome, 70.6% for stroke and 98.7% for stroke/TIA. Bleeding rates were comparable (RR of 0.91, 0.60-1.38, p = 0.66), while there was higher burden of new AF (RR of 5.54, 3-10.2, p < 0.0001) after interventional closure. Subgroup analysis revealed that patients with large shunts had substantial less recurrent strokes over patients with small shunts (p for interaction = 0.02). Use of Amplatzer PFO device was associated with substantial less AF (RR of 2.36, p = 0.06) compared with other devices (RR of 8.93, p < 0.0001) (p for interaction = 0.04), with comparable benefit for stroke prevention (p for interaction = 0.73).
Interventional closure of PFO resulted in significant reduction of stroke and stroke/TIA compared with antiplatelets/anticoagulants with comparable bleeding rates between the groups, whereas AF occurred more frequently in the intervention group. Patients with large shunts had more benefit from interventional closure.
我们旨在探讨卵圆孔未闭（PFO）介入封堵术是否会降低隐源性卒中患者的复合结局[卒中/短暂性脑缺血发作（TIA）、死亡和心肌梗死溶栓治疗-TIMI 出血]、卒中及卒中/TIA 的发生率，与药物治疗相比。
通过检索 PUBMED 和 Cochrane 图书馆数据库，我们对所有比较 PFO 介入封堵术与药物治疗预防卒中效果的随机对照研究进行了荟萃分析。共纳入 6 项随机试验的 3560 例患者。与药物治疗相比，PFO 介入封堵术降低了复合结局（RR 为 0.47，0.26-0.85，p=0.01）、卒中（RR 为 0.38，0.18-0.82，p=0.01）和卒中/TIA（RR 为 0.56，0.43-0.74，p<0.0001）的发生率。分析显示，该研究有 70.5%的把握度可以检测到主要结局 RR 的观察性降低，70.6%的把握度可以检测到卒中，98.7%的把握度可以检测到卒中/TIA。出血发生率无差异（RR 为 0.91，0.60-1.38，p=0.66），但介入封堵术后新发心房颤动（AF）的发生率更高（RR 为 5.54，3-10.2，p<0.0001）。亚组分析显示，与小分流患者相比，大分流患者的复发性卒中明显减少（p 组间差异=0.02）。与其他装置相比（RR 为 8.93，p<0.0001），使用 Amplatzer PFO 装置与 AF 发生率显著降低相关（RR 为 2.36，p=0.06）（p 组间差异=0.04），两组间预防卒中的效果相当（p 组间差异=0.73）。
与抗血小板/抗凝药物相比，PFO 介入封堵术可显著降低卒中及卒中/TIA 的发生率，且两组间出血发生率相当，而介入封堵术后 AF 的发生率更高。大分流患者从介入封堵中获益更多。
