Background: Among patients with cryptogenic stroke, PFO closure has remained controversial. We hypothesized that with the cumulative number of subjects in randomized controlled trials (RCTs), there is now sufficient power to ascertain whether PFO closure in patients with cryptogenic stroke improves the risk of stroke.
Methods: We performed an updated meta-analysis by including newer RCTs that examined the benefit of PFO closure compared with medical therapy for improvement in risk of stroke. We utilized random effects models to compute the association and performed subgroup analyses by medical therapy, shunt size and presence/absence of atrial septal aneurysm.
Results: Overall, 6 RCTS were included with 1839 patients that underwent PFO closure and 1671 patients that received medical therapy and were followed for a period of 2-6 years. The incidence of recurrent stroke was 1.52% among PFO closure group and 3.94% among medical therapy group. There was decreased risk of stroke in PFO closure group (OR 0.34, 95% CI 0.15-0.79, p = 0.012). Patients with larger shunt size derived more benefit from PFO closure than smaller or moderate sized shunts. There was no difference in outcomes by presence or absence of atrial septal aneurysm or type of medical therapy used i.e. antiplatelet therapy only vs. antiplatelet + anticoagulant therapy.
Conclusion: This meta-analysis of 6 RCTs demonstrated benefits of PFO closure for secondary prevention of stroke among patients with cryptogenic stroke and small increase in risk of new onset atrial fibrillation.
Keywords: Cryptogenic stroke; PFO; PFO closure; Patent foramen ovale; Stroke.
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