An Updated Meta-Analysis of Patent Foramen Ovale Closure Versus Medical Therapy for Preventing Recurrent Cryptogenic Stroke

The effectiveness of transcatheter patent foramen ovale (PFO) closure versus medical therapy for preventing recurrent strokes in cryptogenic stroke patients with PFO has been debated, with previous randomized controlled trials (RCTs) yielding mixed results. This meta-analysis was conducted to address these inconsistencies and include new evidence from a recently published RCT, offering updated insights into the efficacy and safety of these treatment strategies. We systematically searched PubMed, Scopus, and Ovid databases through December 2024. Eligible RCTs comparing PFO closure and medical therapy in cryptogenic stroke were included. The risk ratios (RR) with 95% confidence interval (CI) were computed, and P < 0.05 was considered as a level of significance. We performed subgroup analyses based on the presence of atrial septal aneurysm. Statistical analyses were performed using RevMan 5.3 (The Cochrane Collaboration, London, UK). Seven RCTs with 4,539 patients were included. PFO closure reduced recurrent stroke risk (RR: 0.39; 95% CI: 0.21-0.72; P = 0.003). No differences were found for transient ischemic attack (TIA), mortality, or bleeding. PFO closure increased the risk of new-onset atrial fibrillation (RR: 5.14; 95% CI: 2.93-9.01; P < 0.00001). Subgroup analysis showed a significant reduction in stroke with PFO closure in patients with an aneurysm (RR: 0.47; 95% CI: 0.26-0.88; P = 0.02), but not without (RR: 0.72; 95% CI: 0.47-1.11; P = 0.13). Transcatheter PFO closure demonstrates superior efficacy compared to medical therapy alone in reducing the risk of recurrent cryptogenic stroke.