The annualized incidence of stroke with medical therapy was 1.09% (95% CI, 0.88%-1.36%) and with device closure was 0.47% (95% CI, 0.35%-0.65%) (adjusted hazard ratio, 0.41 ). Results Over a median follow-up of 57 months (IQR, 24-64), 121 outcomes occurred in 3740 patients. Main Outcomes and Measures Ischemic stroke.
Subgroup analyses used the Risk of Paradoxical Embolism (RoPE) Score (a 10-point scoring system in which higher scores reflect younger age and the absence of vascular risk factors) and the PFO-Associated Stroke Causal Likelihood (PASCAL) Classification System, which combines the RoPE Score with high-risk PFO features (either an atrial septal aneurysm or a large-sized shunt) to classify patients into 3 categories of causal relatedness: unlikely, possible, and probable.
The trials were conducted worldwide from 2000 to 2017.Įxposures PFO closure plus medical therapy vs medical therapy alone. Objective To evaluate heterogeneity of treatment effect of PFO closure on stroke recurrence based on previously developed scoring systems.ĭesign, Setting, and Participants Investigators for the Systematic, Collaborative, PFO Closure Evaluation (SCOPE) Consortium pooled individual patient data from all 6 randomized clinical trials that compared PFO closure plus medical therapy vs medical therapy alone in patients with PFO-associated stroke, and included a total of 3740 participants. While device closure decreases stroke recurrence risk overall, the best treatment for any individual is often unclear.
Importance Patent foramen ovale (PFO)–associated strokes comprise approximately 10% of ischemic strokes in adults aged 18 to 60 years.