The optimal strategy for preventing recurrent stroke in patients with cryptogenic stroke and patent foramen ovale (PFO) is unknown.

To compare transcatheter PFO closure with medical therapy alone for prevention of recurrent stroke in patients with PFO and cryptogenic stroke.

PubMed and the Cochrane Library (without language restrictions) from inception to October 2017, reference lists, and abstracts from cardiology meetings.

Randomized trials enrolling adults with PFO and cryptogenic stroke that compared stroke outcomes (main outcome) and potential harms in those receiving transcatheter device closure versus medical therapy alone.

Two investigators independently extracted study data and rated risk of bias.

Of 5 trials, 1 was excluded because it used a device that is no longer available due to high rates of complications and failure. Four high-quality trials enrolling 2892 patients showed that PFO closure decreased the absolute risk for recurrent stroke by 3.2% (risk difference, −0.032 [95% CI, −0.050 to −0.014]) compared with medical therapy. The treatment strategies did not differ in rates of transient ischemic attack or major bleeding. Closure of PFOs was associated with higher rates of new-onset atrial fibrillation (AF) than medical therapy alone in all trials, but this outcome had marked between-trial heterogeneity (I² = 82.5%), and high event rates in some groups resulted in extreme values for CIs.

Heterogeneity of device type and antithrombotic therapy across trials, small numbers for some outcomes, and heterogeneous and inconclusive AF results.

In patients with PFO and cryptogenic stroke, transcatheter device closure decreases risk for recurrent stroke compared with medical therapy alone. Because recurrent stroke rates are low even with medical therapy alone and PFO closure might affect AF risk, shared decision making is crucial for this treatment.

None.

预防隐源性中风和卵圆孔未闭 (PFO) 患者复发中风的最佳策略尚不清楚。

比较经导管 PFO 封堵术与单纯药物治疗预防 PFO 和隐源性卒中患者复发性卒中的效果。

PubMed 和 Cochrane 图书馆（无语言限制）从成立到 2017 年 10 月、参考文献列表和心脏病学会议摘要。

招募患有 PFO 和隐源性中风的成人的随机试验，比较了接受经导管装置封堵术与单纯药物治疗的中风结果（主要结果）和潜在危害。

两名研究人员独立提取研究数据并评估偏倚风险。

在 5 项试验中，有 1 项被排除，因为它使用的设备因并发症和失败率高而不再可用。纳入 2892 名患者的四项高质量试验表明，与药物治疗相比，PFO 封堵可将卒中复发的绝对风险降低 3.2%（风险差，-0.032 [95% CI，-0.050 至 -0.014]）。治疗策略在短暂性脑缺血发作或大出血的发生率上没有差异。在所有试验中，与单独药物治疗相比，PFO 封堵与新发心房颤动 (AF) 发生率较高相关，但这一结果具有显着的试验间异质性 (I 2 = 82.5%)，并且某些组中的事件发生^率 较高CI 的极值。

各试验中设备类型和抗血栓治疗的异质性、某些结果的数量较少以及房颤结果的异质性和不确定性。

对于 PFO 和隐源性中风患者，与单纯药物治疗相比，经导管装置封堵可降低复发性中风的风险。由于即使仅采用药物治疗，卒中复发率也很低，而且 PFO 闭合可能会影响 AF 风险，因此共同决策对于这种治疗至关重要。

没有任何。