Patent Foramen Ovale (PFO) closure compared to medical therapy for prevention of stroke recurrence in cryptogenic stroke population: Systematic Review and Meta-Analysis

Abstract

Background Closure of a Patent Foramen Ovale(PFO), may play a role in reducing the risk of recurrent strokes in the cryptogenic stroke population. With recent new evidence published, we aimed to conduct a review of currently available randomised controlled trials(RCT) in order to evaluate the utility of percutaneous device closure of PFO compared to medical therapy in prevention of recurrent strokes. Our aim was to compare the incidence of recurrent stroke between the 2 approaches and also to compare the incidence of transient ischaemic attacks(TIA) and major bleeding between the 2 approaches.

Methods A comprehensive search of major databases was performed. We included comparative RCTs, where outcomes of percutaneous PFO closure with medical therapy were available in patients with cryptogenic stroke and a PFO.

Results Six studies were included with total of 3560 patients. Incidence of recurrent stroke was significantly less in the PFO closure group compared to medical therapy (2.86% vs. 5.09%, OR 0.49, 95% CI 0.35 – 0.70, p < 0.0001). Incidence of TIA was not significantly different in both PFO closure group compared to medical therapy (2.75% vs. 3.83%, OR 0.79, 95% CI 0.54 – 1.15, p = 0.22). Major bleeding was shown to not be significantly different in PFO closure group compared to medical therapy (1.64% vs. 1.76%, OR 0.90, 95% CI 0.54 – 1.49, p = 0.68) either. Sub group analysis of patients with ASA, comparing PFO closure group to medical therapy showed significant benefit in terms of stroke prevention in the PFO closure group (3.02% vs. 7.99%, OR 0.39, 95% CI 0.21 – 0.72, p = 0.002). Sub group analysis of large intra-atrial shunt similarly showed significant benefit in terms of stroke prevention in the PFO closure group (1.43% vs. 5.40%, OR 0.26, 95% CI 0.13 – 0.51, p < 0.0001).

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Conclusion When combining all trials published so far, our analysis demonstrates a net beneficial effect of PFO closure overall. Our study also highlights the need of a dedicated RCT to explore PFO closure compared to oral anticoagulation to reduce the likelihood of bias in the future.