Closure of Patent Foramen Ovale Is No More Effective at Preventing Stroke Than Medical Therapy Alone
In patients with cryptogenic stroke or transient ischemic attack (TIA), closing a patent foramen ovale (PFO) with a device does not prevent recurrent stroke more effectively than medical treatment alone, according to research published in the March 15 issue of the New England Journal of Medicine. After two years of follow-up, the rate of stroke was 2.9% among patients who received PFO closure, compared with 3.1% among patients who received medications alone. The rate of TIA among patients who received PFO closure was 3.1%, compared with 4.1% among patients who received medications alone.
To evaluate the benefit of the STARFlex septal closure system, Anthony J. Furlan, MD, Professor and Chairman of Neurology at Case Western Reserve University in Cleveland, and colleagues conducted a prospective, multicenter, randomized, open-label superiority trial. The researchers enrolled 909 patients with a PFO who had had a stroke or TIA within the previous six months. A group of 447 patients received PFO closure with the STARFlex device and a subsequent antiplatelet regimen of clopidogrel and aspirin. A second group of 462 patients received warfarin, aspirin, or both at the discretion of each site’s principal investigator. About 52% of patients were male, and participants’ mean age was approximately 46.
Nearly 6% of patients who received PFO closure experienced atrial fibrillation afterward, compared with 0.7% of patients who received drugs alone. This result “suggests that the closure procedure itself may increase the risk of atrial fibrillation,” said Dr. Furlan. “Indeed, 61% of the observed cases of atrial fibrillation were periprocedural,” he added.
“Our findings do not preclude a possible role for closure of a [PFO] in highly selected patient populations,” noted Dr. Furlan. “However, it may be difficult to prove that closure with a percutaneous device is superior to medical therapy even in such populations,” he concluded.
Although limited by a small sample size and a patient population that may not be representative of the device’s target population, the trial “provides the best evidence available regarding the role of closure in stroke prevention,” wrote S. Claiborne Johnston, MD, PhD, of the Neurovascular Disease and Stroke Center, University of California, San Francisco, in an accompanying editorial. The study’s results “do not support closure of a [PFO] to prevent stroke in patients who have had a stroke or a TIA of unclear etiology,” he concluded.
Furlan AJ, Reisman M, Massaro J, et al. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med. 2012;366(11):991-999.
Johnston SC. Patent foramen ovale closure—closing the door except for trials. N Engl J Med. 2012;366(11):1048-1050.