Background: The Gore REDUCE Clinical Study (REDUCE) demonstrated superiority of PFO closure in conjunction with antiplatelet therapy over antiplatelet therapy alone in reducing the risk of recurrent clinical ischemic stroke or new silent brain infarct in patients with cryptogenic stroke.
Methods: We randomized 664 subjects with cryptogenic stroke at 63 multinational sites in a 2:1 ratio to either antiplatelet therapy plus PFO closure (with Gore HELEX Septal Occluder or Gore CARDIOFORM Septal Occluder) or antiplatelet therapy alone. Co-primary endpoints were freedom from recurrent clinical ischemic stroke through ≥2 years and incidence of new brain infarct (defined as the composite of clinical ischemic stroke and silent brain infarct) at 2 years. Primary analyses were performed on the intention-to-treat (ITT) population. Per-protocol (PP) analysis included only subjects randomized and treated according to critical protocol requirements (excluding those who violated key eligibility criteria, did not receive the therapy to which they were randomized, or did not comply with protocol-required medical regimen). As-treated (AT) analysis assessed all subjects based on treatment received, regardless of study assignment.
Results: PFO closure was associated with a highly consistent reduction in risk compared to medical therapy alone in all three analytic cohorts (Table).
Conclusions: Among selected patients with cryptogenic stroke and PFO, closure of the PFO plus antiplatelet therapy was superior to antiplatelet therapy alone for reducing the risk of subsequent ischemic stroke.