Patent Foramen Ovale Closure Versus Medical Therapy for Cryptogenic Stroke: Meta-Analysis of Randomised Trials.

Background: Patent foramen ovale (PFO) is a common anatomic variant associated with cryptogenic stroke. Percutaneous PFO closure in these patients to prevent recurrent neurological events has been controversial for decades, and mixed results have been reported from past and recent observational and randomised studies. This meta-analysis of randomised trials aims to compare the efficacy and safety of PFO closure with medical therapy for cryptogenic stroke patients.

Methods: Medline, PubMed, EMBASE, Scopus and Cochrane were searched from January 1980 to September 2017 by two authors independently to include original randomised trials comparing PFO closure with medical therapy for secondary stroke prevention. Relevant study and baseline characteristics and outcomes were extracted and pooled using random-effects models.

Results: Amongst 619 articles searched giving 10 full-texts assessed, six studies reporting five randomised trials and totalling 1,829 PFO closure and 1,611 medical therapy patients were included. Pooled hazards ratios (95% confidence interval, p-value) ischaemic stroke, transient ischaemic attack (TIA) and composite neurovascular or mortality events were 0.41 (0.19-0.90, p=0.03), 0.77 (0.51-1.14, p=0.19) and 0.60 (0.44-0.81, p<0.001) for PFO closure compared to medical therapy. Any adverse events, major bleeding and all-cause mortality were similar between modalities (p=0.37-0.95), however PFO closure had higher rates of new onset atrial fibrillation at 4.6 times (p<0.001).

Conclusion: Our meta-analysis found that, in patients with cryptogenic stroke, percutaneous PFO closure is beneficial at reducing ischaemic stroke and composite neurovascular or mortality events, with a higher incidence of new atrial fibrillation, compared to medical therapy.