The Case for Selective Patent Foramen Ovale Closure After Cryptogenic Stroke [Advances in Interventional Cardiology]

Controversy has persisted for over a decade whether transcatheter patent foramen ovale (PFO) closure reduces the rate of recurrent ischemic stroke for patients who have had a cryptogenic ischemic stroke and have a PFO. In September 2017, 3 positive randomized trials: RESPECT long-term (Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment trial), REDUCE (GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale [PFO]), and CLOSE (Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence) were published. All 3 trials studied young to middle age patients with cryptogenic ischemic strokes found to have a PFO, and compared recurrent stroke rates after PFO closure versus medical therapy alone. All trials had primary end points of recurrent ischemic strokes, a superiority design, and reported results in the intention to treat population. The long-term results of the RESPECT trial led to the Food and Drug Administration approval of the AMPLATZER PFO Occluder for a secondary prevention indication. There was a 45% risk reduction in the device arm for recurrent ischemic stroke with an event rate of 0.58 versus 1.07 per 100 patient-years (hazard ratio, 0.55; 95% confidence interval, 0.305–0.999; log-rank P=0.046). The primary efficacy result of the REDU...
Source: Circulation: Cardiovascular Interventions - Category: Cardiology Authors: Tags: Secondary Prevention, Treatment, Ischemic Stroke Advances in Interventional Cardiology Source Type: research