Department of Internal Medicine, Spital Zollikerberg, Zollikerberg, Switzerland.
Heart. 2014 Mar;100(5):389-95. doi: 10.1136/heartjnl-2013-304394. Epub 2013 Jun 21.
The role of percutaneous closure of patent foramen oval (PFO) in patients with cryptogenic stroke has been very controversial for years due to a lack of clear evidence.
Systematic review and meta-analysis of the effect of percutaneous PFO closure for secondary prevention of cryptogenic strokes as compared to best medical therapy (BMT).
Trials were identified through a literature search until 28 May 2013.
Controlled clinical trials (randomised and non-randomised) comparing percutaneous PFO closure with BMT.
Main end point of interest was stroke. A random effects model was used to calculate the pooled relative risks (RR) with 95% CIs.
A total of 14 studies (three randomised controlled trials (RCT) and 11 non-randomised observational studies (non-RCT)), and a total of 4335 patients were included for this analysis. There was no significant treatment effect of PFO closure regarding stroke among the RCT (RR 0.66, 95% CI 0.37 to 1.19, p=0.171). However, among non-RCT stroke was reduced (RR 0.37, 95% CI 0.20 to 0.67, p<0.001) after PFO closure. A time-to-event (stroke) analysis, combining all three RCT and the two non-RCT which applied strict multivariate adjustments, showed a borderline significant risk reduction after PFO closure (HR 0.58, 95% CI 0.33 to 0.99, p=0.047). Neither risk of bleeding nor mortality differed significantly between the groups. However, there was a higher incidence of new onset atrial fibrillation in the closure group (RR 3.50, 95% CI 1.47 to 8.35, p=0.005).
Percutaneous closure of PFO in patients with cryptogenic stroke does not appear superior to medical therapy according to currently available randomised data. Furthermore, it is associated with an increased incidence of atrial fibrillation. However, there are signals pointing towards a potential benefit and more research should be strongly encouraged.
由于缺乏明确的证据，多年来，经皮卵圆孔未闭（PFO）封堵术在隐源性卒中患者中的作用一直存在很大争议。
系统评价和荟萃分析经皮 PFO 封堵术与最佳药物治疗（BMT）相比对隐源性卒中二级预防的效果。
通过文献检索，研究人员于 2013 年 5 月 28 日之前确定了试验。
比较经皮 PFO 封堵术与 BMT 的对照临床试验（随机和非随机）。
主要终点为卒中。使用随机效应模型计算汇总相对风险（RR）及其 95%置信区间（CI）。
共有 14 项研究（3 项随机对照试验（RCT）和 11 项非随机观察性研究（non-RCT）），共纳入 4335 例患者进行了此项分析。RCT 中 PFO 封堵术对卒中无显著治疗作用（RR 0.66，95%CI 0.37 至 1.19，p=0.171）。然而，在 non-RCT 中，PFO 封堵术后卒中减少（RR 0.37，95%CI 0.20 至 0.67，p<0.001）。对所有 3 项 RCT 和应用严格多变量调整的 2 项 non-RCT 的时间事件（卒中）分析显示，PFO 封堵后风险降低具有边缘显著意义（HR 0.58，95%CI 0.33 至 0.99，p=0.047）。两组之间的出血或死亡率无显著差异。然而，封堵组新发心房颤动的发生率更高（RR 3.50，95%CI 1.47 至 8.35，p=0.005）。
根据目前可用的随机数据，经皮 PFO 封堵术在隐源性卒中患者中似乎并不优于药物治疗。此外，它与心房颤动发生率增加有关。然而，有迹象表明可能存在获益，应强烈鼓励开展更多研究。
