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Patent foramen ovale (PFO) closure reduced recurrent stroke and composite thromboembolic events compared with antithrombotic therapy in selected patients with cryptogenic stroke, according to an updated meta-analysis published in Future Cardiology.

Randomized studies identified through systematic searches of MEDLINE, Embase, and the Cochrane Central Register through September 2025 were analyzed. Primary outcomes included recurrent stroke, transient ischemic attack (TIA), and a composite of stroke, TIA, death, or systemic embolism. Serious adverse events and atrial fibrillation (AF) were also assessed.

Six randomized trials involving 3560 participants were analyzed. Among them, 1889 patients underwent PFO closure and 1671 received antithrombotic therapy. Composite thromboembolic events occurred in 4.4% of patients undergoing PFO closure and 9.1% of those receiving medical therapy. PFO closure significantly lowered the composite endpoint (hazard ratio [HR] 0.46; 95% confidence interval [CI] 0.28–0.75; p=0.002).

Recurrent stroke occurred in 2.0% of patients in the closure group and 4.6% of those receiving antithrombotic therapy (HR 0.27; 95% CI 0.12–0.62; p=0.002). Subgroup analyses showed greater benefit among men, patients younger than 45 years, and individuals with large interatrial shunts. Rates of serious adverse events and mortality were similar between groups. However, AF occurred more frequently after PFO closure than with antithrombotic therapy (HR 4.46; 95% CI 2.00–9.92; p<0.001).

The findings support PFO closure as an effective strategy for reducing recurrent cerebrovascular events in selected patients with cryptogenic stroke, although AF occurred more frequently after the procedure.

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Key highlights
  • PFO closure reduced recurrent stroke risk versus antithrombotic therapy (HR 0.27; p=0.002)
  • Composite thromboembolic events were lower with PFO closure (HR 0.46; p=0.002)
  • Greater benefit was observed in men, patients younger than 45 years, and those with large shunts
  • Atrial fibrillation occurred more frequently after PFO closure (HR 4.46; p<0.001)
Source

Tewari J, Agrawal H, Dubey P, et al. Safety and efficacy of percutaneous patent foramen ovale closure compared with anti-thrombotic therapy for people with cryptogenic stroke: a systematic review and meta-analysis. Future Cardiol. Published online May 8, 2026. doi:10.1080/14796678.2026.2665753

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A meta-analysis of six randomized trials compared patent foramen ovale closure with antithrombotic therapy after cryptogenic stroke. 

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