- Question
- Does patent foramen ovale (PFO) closure added to antiplatelet therapy reduce the risk of recurrent stroke and new brain infarctions compared with antiplatelet therapy alone after a cryptogenic stroke?
- Design
- Multinational randomized trial with 2:1 allocation and brain imaging at baseline and at 24 months; the registry lists single-blind masking and the sponsor was W.L. Gore. A total of 664 patients were enrolled, with a median follow-up of 3.2 years.
- Population
- Patients with a PFO who had had a cryptogenic stroke, mean age 45.2 years; 81% had a moderate or large interatrial shunt.
- Intervention
- Percutaneous PFO closure with a septal occluder device plus antiplatelet therapy.
- Control
- Antiplatelet therapy alone.
- Primary outcome
- Two coprimary end points: freedom from clinical ischemic stroke through at least 24 months (reported as the percentage with stroke recurrence) and the 24-month incidence of new brain infarction, defined as clinical ischemic stroke or silent brain infarction on imaging.
- Results
- Clinical ischemic stroke occurred in 6 of 441 patients (1.4%) with PFO closure and in 12 of 223 (5.4%) with antiplatelet therapy alone (HR 0.23; 95% CI 0.09 to 0.62; P=0.002). New brain infarctions were less frequent with closure (5.7% vs. 11.3%; RR 0.51; 95% CI 0.29 to 0.91; P=0.04), with no significant difference in silent brain infarction (P=0.97).
- Safety
- Serious adverse events occurred in 23.1% of the closure group and 27.8% of the antiplatelet-only group (P=0.22). Serious device-related adverse events occurred in 6 patients (1.4%) and atrial fibrillation in 29 patients (6.6%) after closure.
- Conclusion
- In patients with a PFO and cryptogenic stroke, closure plus antiplatelet therapy lowered the risk of subsequent ischemic stroke versus antiplatelet therapy alone, at the cost of more device complications and atrial fibrillation.
- Why it matters
- It provided evidence supporting PFO closure in selected patients with cryptogenic stroke and underscored the need to weigh the benefit against procedural and device-related risks.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026