No Apparent Benefit from PFO Closure After Cryptogenic Stroke

At least 20% of strokes have no known cause and are labeled as cryptogenic. Patients with cryptogenic stroke have a high prevalence of patent foramen ovale (PFO), suggesting that this passage between the right and left heart allows paradoxical embolization from the systemic circulation. Cardiac devices for treating atrial septal defects are used off-label to close PFOs after cryptogenic stroke, but rigorous evidence about this practice has been lacking. Investigators have now performed a trial comparing PFO closure (using the study sponsor's device) with medical therapy alone. During a 5-year period, the investigators randomized 909 patients at 87 sites to closure or medical therapy alone (aspirin, warfarin, or both). Participants were aged…