Efficacy of percutaneous closure of patent foramen ovale in preventing recurrent events, compared with standard medical therapy in patients with cryptogenic ischemic stroke: Systematic review and meta-analysis

INTRODUCTION: It is not clear what is the most effective treatment for the prevention of recurrent stroke or transient ischemic attack (TIA) in patients with patent foramen ovale and cryptogenic ischemic cerebrovascular disease (CVD). OBJECTIVE: To determine the efficacy of the percutaneous closure of patent foramen ovale in the prevention of recurrent stroke in patients with cryptogenic stroke or TIA. METHODS: We performed a search in PubMed, EMBASE, KoreaMed, LILACS, and the Cochrane Librarydatabases. We included randomized controlled trials evaluating the efficacy of percutaneous closure of patent foramen ovale compared with standard medical therapy for the prevention of recurrent stroke in adults with cryptogenic CVD. Were recalculated relative risks [RR, and 95% confidence interval (CI)] for the primary outcome of fatal or non-fatal stroke, TIA or all-cause mortality. The combined analysis of the effect size was calculated based on the intention-to-treat population (ITT) for the primary outcome. RESULTS: Of 108 references initially identified, we included 3 studies that satisfactorily met the criteria for this analysis: CLOSUREI (n = 909), PC Trial (n = 980) and RESPECT (n = 414), published between 2012 and 2013. The meta-analysis of the 3 studies was on 2,303 patients in the intention-to-treat populations of each study (percutaneous closure n = 1,150; n = 1,153 medical treatment). The combined analysis recalculated showed no significant reduction of the risk for the primary endpoint of fatal or non-fatal stroke, TIA or all-cause mortality (RR: 0.72; 95% CI: 0.49-1.06). This effect was not different with the sequential exclusion of each study. CONCLUSIONS: The best available evidence to date shows that percutaneous closure of patent foramen ovale is not superior to standard medical therapy in preventing recurrent stroke or death in patients with cryptogenic acute ischemic CVD.