Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis

Context 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. Objective 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). Data sources Trials were identified through a literature search until 28 May 2013. Study selection Controlled clinical trials (randomised and non-randomised) comparing percutaneous PFO closure with BMT. Data extraction and synthesis Main end point of interest was stroke. A random effects model was used to calculate the pooled relative risks (RR) with 95% CIs. Results 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