What trials are available to evaluate mechanical closure of echocardiographically detected PFO to prevent recurrent stroke in patients without an obvious cause for their index stroke?
Six RCTs have evaluated mechanical closure of echocardiographically detected PFO to prevent recurrent stroke in patients without an obvious cause for their index stroke.311 317 These trials had highly restrictive eligibility criteria that required brain MRI, imaging of the intracranial vasculature, and echocardiography. Meta-analyses of these trials show a significantly reduced risk of recurrent stroke with mechanical closure compared with medical therapy with a number needed to treat of 131.318 320 A network meta-analysis concluded that, in patients <60 years of age, PFO closure probably confers an important reduction in ischemic stroke recurrence compared with antiplatelet therapy alone but may make no difference compared with anticoagulation. PFO closure also incurs a risk of persistent atrial fibrillation and device-related adverse events.