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Background  We conducted a systematic review and meta‐analysis of randomized controlled trials ( RCT s) comparing patent foramen ovale ( PFO ) closure, anticoagulation, and antiplatelet therapy to prevent stroke recurrence in patients with  PFO ‐associated cryptogenic stroke.    Methods and Results  We searched Medline, Cochrane Library, and EMBASE through March 2018. The primary outcome was stroke recurrence. Pooled incidences, hazard ratios, and risk ratios ( RR s) were calculated in random‐effects meta‐analyses.  PFO  closure was associated with a lower risk of recurrent stroke compared with antithrombotic therapy (antiplatelet therapy or anticoagulation: 3560 patients from 6  RCT s;  RR =0.36, 95%  CI : 0.17–0.79; I 2 =59%). The effect of  PFO  closure on stroke recurrence was larger in patients with atrial septal aneurysm or large shunt ( RR =0.27, 95%  CI , 0.11–0.70; I 2 =42%) compared with patients without these anatomical features ( RR =0.80, 95%  CI , 0.43–1.47; I 2 =12%). Major complications occurred in 2.40% (95%  CI , 1.03–4.25; I 2 =77%) of procedures. New‐onset atrial fibrillation was more frequent in patients randomized to  PFO  closure versus antithrombotic therapy ( RR =4.33, 95%  CI , 2.37–7.89; I 2 =14%). One  RCT  compared  PFO  closure versus anticoagulation (353 patients; hazard ratio=0.14, 95%  CI , 0.00–1.45) and 2  RCT s compared  PFO  closure versus antiplatelet therapy (1137 patients; hazard ratio=0.18, 95%  CI , 0.05–0.63; I 2 =12%). Three  RCT s compared anticoagulation versus antiplatelet therapy, with none showing a significant difference.    Conclusions   PFO  closure is superior to antithrombotic therapy to prevent stroke recurrence after cryptogenic stroke. The annual absolute risk reduction of stroke was low, but it has to be tempered by a substantial time at risk (at least 5 years) in young and middle‐aged patients.  PFO  closure was associated with an increased risk of atrial fibrillation.

journal of the american heart association

Closure, Anticoagulation, or Antiplatelet Therapy for Cryptogenic Stroke With Patent Foramen Ovale: Systematic Review of Randomized Trials, Sequential Meta‐Analysis, and New Insights From the  CLOSE  Study