ABSTRACT NUMBER: ESOC2026A1706 PATENT FORAMEN OVALE CLOSURE BEYOND THE YOUNG AND CRYPTOGENIC: A MULTICENTER PROSPECTIVE STUDY IN OLDER PATIENTS AND THOSE WITH COMPETING STROKE ETIOLOGIES

Abstract Background and aims Percutaneous device closure (PDC) is beneficial in preventing recurrent ischemic stroke in selected young patients with cryptogenic stroke and patent foramen ovale (PFO). The effect of PDC in older stroke patients with PFO and those with alternative stroke etiologies remains controversial. Methods This prospective, multicenter, international cohort study comprised 1835 patients with ischemic stroke and PFO treated either with PDC (n=793) or best medical treatment (BMT, n=1042). Inclusion was not restricted by age or stroke subtype. We assessed a composite of recurrent stroke, transient ischemic attack or another arterial embolic event as the primary outcome and performed subgroup analyses for age, stroke etiology, and PASCAL classification. Results The composite outcome was 5.3% in PDC and 6.9% in BMT treated patients (adjusted Hazard Ratio (aHR) 0.759, 95%CI 0.493–1.169, p=0.211) during a median follow-up of 36 months. This treatment effect was consistent in patients <60 years (aHR=0.727, 95%CI 0.424–1.245) and in those >60 years (aHR=0.731, 95%CI 0.376–1.421; p=0.989). In addition, subgroup analyses showed a numerical benefit of PDC over BMT in patients with higher RoPE score and high risk PFO features such as large shunt size and atrial septum aneurysm (PASCAL probable, HR 0.396; 95%CI 0.156–1.001; p=0.056). Treatment effects did not differ significantly between patients with cryptogenic or alternative etiologies. Conclusions In this large real-world cohort we showed, that PFO closure was associated with consistent beneficial treatment effects across a broad spectrum of patients, including those ≥60 years and individuals with potential alternative stroke mechanisms. Conflict of interest Nothing to disclose.