Department of Cardiovascular Diseases, Campus Benjamin Franklin, Charite'-Universitätsmedizin Berlin, and German Centre for Cardiovascular Research (DZHK), Partner Site Berlin, Berlin, Germany.
German Heart Center Munich, Technische Universität München, Munich, Germany.
Clin Res Cardiol. 2018 Sep;107(9):788-798. doi: 10.1007/s00392-018-1246-y. Epub 2018 Apr 11.
We performed an updated meta-analysis of all randomized-controlled trials (RCTs) comparing patent foramen ovale (PFO) closure with medical therapy for prevention of recurrent ischemic stroke.
We searched Medline, EMBASE, and Cochrane databases, and proceedings of international meetings for RCTs of patients with cryptogenic stroke and PFO comparing percutaneous PFO closure versus medical therapy for prevention of recurrent ischemic stroke. The primary outcome was a composite ischemic/embolic endpoint comprising stroke, transient ischemic attack (TIA), peripheral embolism, and early death in the intention-to-treat population. Secondary outcomes were all-cause death, stroke, TIA, atrial fibrillation (AF), and major bleeding. Of 3440 enrolled patients across five RCTs, 1829 were allocated to PFO closure and 1611 to medical therapy. The follow-up ranged from 2 to 5.9 years. PFO closure reduced the risk of the composite outcome [HR 0.52, (0.36-0.77); p < 0.01], and stroke, [HR 0.39, (0.19-0.83); p < 0.01], and increased the risk of AF [OR 3.75, (2.44-5.78); p < 0.01] as compared to medical therapy. NNT for stroke was 37 and NNH for AF 49, indicating a net clinical benefit of PFO closure. The meta-analysis had 95% power to detect a 50% relative risk reduction (RRR) in the primary outcome and 89% power to detect a 70% RRR in ischemic stroke. The risk of all-cause death (HR 1.08, p = 0.90), TIA [HR 0.73, (0.49-1.09); p = 0.12], and major bleeding [OR 0.97, (0.44-2.17); p = 0.95] was comparable between the groups.
Among patients with cryptogenic stroke and PFO, percutaneous closure of PFO is superior to medical therapy in preventing recurrent ischemic/embolic events and stroke but is associated with an increased risk of AF.
我们对所有比较卵圆孔未闭（PFO）封堵与药物治疗预防复发性缺血性卒中的随机对照试验（RCT）进行了更新的荟萃分析。
我们检索了 Medline、EMBASE 和 Cochrane 数据库以及国际会议的会议记录，以寻找比较隐源性卒中合并 PFO 患者经皮 PFO 封堵与药物治疗预防复发性缺血性卒中的 RCT。主要结局是意向治疗人群中包括卒中、短暂性脑缺血发作（TIA）、外周栓塞和早期死亡的复合缺血/栓塞终点。次要结局为全因死亡、卒中、TIA、心房颤动（AF）和大出血。在纳入的 5 项 RCT 中，共有 3440 例患者，其中 1829 例被分配至 PFO 封堵组，1611 例被分配至药物治疗组。随访时间为 2 至 5.9 年。PFO 封堵降低了复合结局的风险[风险比（HR）0.52，（0.36-0.77）；p<0.01]和卒中风险[HR 0.39，（0.19-0.83）；p<0.01]，但增加了 AF 的风险[比值比（OR）3.75，（2.44-5.78）；p<0.01]。与药物治疗相比。卒中的 NNT 为 37，AF 的 NNH 为 49，表明 PFO 封堵具有净临床获益。该荟萃分析有 95%的效能可检测主要结局 50%的相对风险降低（RRR），89%的效能可检测缺血性卒中 70%的 RRR。全因死亡风险（HR 1.08，p=0.90）、TIA[HR 0.73，（0.49-1.09）；p=0.12]和大出血[OR 0.97，（0.44-2.17）；p=0.95]的风险在两组之间无差异。
在隐源性卒中合并 PFO 的患者中，经皮 PFO 封堵在预防复发性缺血/栓塞事件和卒中方面优于药物治疗，但与 AF 风险增加相关。
