• Abdul Hakeem, Konstantinos Marmagkiolis, Yalcin Hacioglu, Barry F Uretsky, Betul Gundogdu, Massoud Leesar, Steven R Bailey, and Mehmet Cilingiroglu.
• University of Arkansas for Medical Sciences, Little Rock, AR, USA.
• Cardiovasc Revasc Med. 2013 Nov 1; 14 (6): 349-55.

BackgroundControversy persists regarding the management of patients with cryptogenic stroke and patent foramen ovale (PFO). We performed a meta-analysis of randomized controlled trials comparing PFO closure with medical therapy.Methods And ResultsA prospective protocol 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. Three randomized trials comparing percutaneous PFO closure vs. medical therapy for secondary prevention of embolic neurological events formed the data set. Baseline characteristics were similar. 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) 0.7 (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.ConclusionsWhile this meta-analysis of randomized clinical trials demonstrated no statistical significance in comparison to medical therapy, there was a trend towards overall improvement in outcomes in the PFO closure group.© 2013.

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