REDUCE Trial PFO Selection Criteria Model (Eligibility RoPE PASCAL)
REDUCE Trial PFO Selection Criteria Model — Explanation and Clinical Context This tool first reproduces the original REDUCE trial eligibility logic (age 18–59 years, cryptogenic non-lacunar ischemic stroke within ≤180 days, and patent foramen ovale with a right-to-left shunt) and screens out key exclusions (atrial fibrillation or another high-risk cardioembolic source, ≥50% relevant arterial stenosis/occlusion, hypercoagulable states, and uncontrolled diabetes or hypertension). This mirrors the patient population in whom PFO device closure reduced recurrent ischemic stroke versus antiplatelet therapy alone.
To improve precision beyond trial entry criteria, the calculator then estimates causal likelihood using the RoPE score (0–10) and integrates PFO anatomy (large shunt and/or atrial septal aneurysm) via the PASCAL classification. Patients with RoPE ≥7 and high-risk PFO features typically fall into the “probable” category and show the greatest relative benefit from closure; those with only one of these elements are “possible,” while patients with low RoPE and no high-risk features are “unlikely” and generally derive no net benefit from closure. Results should support, not replace, multidisciplinary decision-making and guideline-directed care.
References:
Søndergaard L, Kasner SE, Rhodes JF, et al. Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke (REDUCE). N Engl J Med. 2017;377:1033-1042.
American College of Cardiology. REDUCE PFO Trial Summary (inclusion/exclusion criteria and outcomes).
Stroke-Manual: Risk of Paradoxical Embolism (RoPE) Score and PASCAL classification tables (updated 2025).
Sposato LA, et al. Stroke 2024: Net clinical effect across PASCAL strata.
ESC Council for Cardiology Practice. Patent foramen ovale in patients with cryptogenic stroke: to close or not to close (2025 update).