Transcatheter Patent Foramen Ovale Closure Versus Medical Therapy For Cryptogenic Stroke: A Meta-analysis

Objective: There is an association between cryptogenic stroke and patentforamen ovale (PFO). The optimal treatment strategy for secondary prevention is stillunclear. The purpose of this meta-analysis was to estimate the effectiveness andsafety of transcatheter device closure compared with standard drug therapy.Methods: Search published RCTs from CNKI, CBM, pubmed, cochrane library,Ovid. Endnote and Stata software were used for management and analysis ofliterature respectively..The primary outcome was a composite end-point includingdeath, stroke and transient-ischemic attack (TIA), which presented as hazard ratios(HRs) with95%confidence intervals (CIs).In safety analysis，we reported outcomeof atrial fibrillation and bleeding events, the results were presented as Relative Risks(RRs) with95%confidence intervals (CIs) and heterogeneity inspection was carriedby I2inspection. Data was synthesized using a fixed or random effects model.Pre-defined subgroup analysis was performed with respect to baseline characteristicsincluding age, sex, neurological event of subjects, occluder, atrial septal aneurysmand shunt size. Literature screening, quality assessment and data extraction wasperformed by two reviewers independently.Results: This research incorporate3randomized clinical trials including2303patients. Transcatheter closure was not superior to medical therapy in the secondaryprevention of stroke or TIA in intention-to-treat analysis (HR:0.665,95%CI:0.441to1.003; p=0.052). There was more atrial fibrillation in transcatheter closure group(RR:3.58,95%CI:1.39to9.20; p=0.008). In subgroup analysis, Amplatzer PFOoccluder was superior to drug therapy for the secondary prevention of stroke (HR:0.44,95%CI:0.21to0.94; p=0.035). Males have significant benefit from deviceclosure (HR:0.48,95%CI:0.24to0.96; p=0.038).Conclusions: In this meta-analysis, transcatheter device closure of PFO have atendency in the secondary prevention of the composite end-point. But there was nosignificant difference between two groups. Amplatzer PFO occluder is more useful than drugs for the secondary prevention of stroke. Males may have significant benefitfrom device closure, and atrial fibrillation was more in transcatheter closure group.