No Apparent Benefit from PFO Closure After Cryptogenic Stroke

In the first published randomized trial of patent foramen ovale closure, recurrent strokes were uncommon and usually unrelated to PFO.


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 18 to 60 with recent stroke or transient ischemic attack (TIA), right-to-left shunting on transesophageal echocardiography, and no identifiable cause of stroke besides PFO.

PFO closure was durably successful in 86.7% of closure-device recipients. Cumulatively over 2 years, recurrent stroke or TIA occurred in 5.5% of the closure group versus 6.8% of the medical-therapy group, a nonsignificant difference (adjusted hazard ratio, 0.78; 95% confidence interval, 0.45–1.35). Most recurrent events had sources unrelated to PFO.


Citation(s):

Furlan AJ et al. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012 Mar 15; 366:991.