Abstract 9324: Safety and Efficacy of Device Closure for Patent Foramen Ovale for Secondary Prevention of Neurological events. Meta-analysis of Randomized Controlled Trials

Abstract

Background: While the prevalence of patent foramen ovale (PFO) is significantly higher in patients with cryptogenic stroke, considerable controversy persists regarding the best management of such patients. We performed a meta-analysis of randomized controlled trials comparing PFO closure with medical therapy. Methods: A prospective protocol (Protocol registration # CRD42013004197) was developed and registered using the following data sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and internet-based resources of clinical trials. Primary analyses were performed using the intention-to-treat method as reported in the respective trials Results: Three randomized trials comparing percutaneous PFO closure vs. medical therapy for secondary prevention of embolic neurological events involving 2303 participants (1153 medical therapy, 1150 PFO closure) formed the data set. Two trials (RESPECT and PC) used the Amplatzer PFO occluder whereas the Starflex closure device was used in the CLOSURE 1 trial. Baseline characteristics were similar. Mean age was 46 years. The prevalence of atrial septal aneurysm was similar (approximately 34% in both groups). During long-term follow-up , the pooled incidence of the primary endpoint (composite of stroke, death, or fatal stroke) was 3.4 % in the PFO closure arm and 4.8% in the medical therapy group [risk reduction (RR) 0.71 (0.48-1.06); p=0.09] The incidence of recurrent neurological events (secondary endpoint) was 1.7% for PFO closure and 2.7% for medical therapy[ RR 0.66 (0.35,1.24), p=0.19]. There was no difference in terms of death or adverse events between the two groups. After transcatheter closure, recurrent neurological events did not seem to be related to pre-treatment shunt size or atrial septal aneurysm. Reduction in primary event rate with closure strategy (in comparison to medical therapy) almost reached statistical significance (P=0.05) in male patients. Conclusions: While this meta-analysis of randomized clinical trials demonstrated no statistical significance in comparison to medical therapy, there was a strong trend towards overall improvement in outcomes in the PFO closure group.