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.
Early Surgery Plus AED Treatment Is More Effective Than Medication Alone for Drug-Resistant Epilepsy
Patients with newly intractable mesial temporal lobe epilepsy (MTLE) who received resective surgery and antiepileptic drugs (AEDs) had a lower probability of experiencing seizures than patients who received AEDs alone, according to a study published in the March 7 issue of JAMA.
At the end of a two-year follow-up, quality of life was higher in patients who had undergone surgery than it was in medically treated patients, but not to a statistically significant degree. Several medically treated patients underwent surgery before the end of follow-up, however. When postsurgery data for these patients were excluded, the effect of surgery on quality of life was significant.
Jerome Engel Jr, MD, PhD, of the Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles (UCLA), and colleagues conducted a multicenter, controlled trial to determine whether surgery soon after the failure of two AEDs was superior to continued medical management of epilepsy. The study’s 38 participants (18 men) had MTLE and disabling seizures for no more than two consecutive years after adequate trials of two brand-name AEDs. After randomization, 23 patients received continued AED treatment, and 15 received standardized anteromesial temporal resection (AMTR) and AED treatment.
The primary outcome was freedom from disabling seizures at the end of follow-up. Secondary outcomes included health-related quality of life, cognitive function, and social adaptation. The investigators halted the study prematurely because of the slow rate of patient recruitment.
“The benefit of surgery in newly intractable epilepsy is very large,” said the researchers. “Patients who continue pharmacotherapy at this early stage of intractability have a very low likelihood of being seizure free during the second year,” they added. “Because only two participants in this study were younger than 17 years, and none were in the surgical group, it is unknown whether these results apply to adolescents with MTLE,” the investigators noted.