Landmark Study Finds Expensive Catheter Procedure to Close Hole in Heart No More Effective Than Medical Therapy to Prevent Strokes
CLEVELAND, March 14, 2012 /PRNewswire/ -- A catheter procedure that closes a hole in patients' hearts is no more effective than medical therapy in preventing recurrent strokes, according to a new study published in the March 15 issue of the New England Journal of Medicine.
In the CLOSURE I trial, clinical researchers compared a catheter procedure plus medical therapy with medications alone to prevent new strokes or transient ischemic attacks (TIAs) in patients between 18 and 60 years old with an unexplained ("cryptogenic") stroke or TIA and a patent foremen ovale (PFO) – a hole between the heart's two upper chambers.
In the ground-breaking, international multi-site study led by University Hospitals (UH) Case Medical Center and Case Western Reserve University School of Medicine, researchers sought to demonstrate the superiority of the STARFlex® Septal Closure System over medical therapies (aspirin or warfarin) alone. Instead, results showed no statistically significant differences between the two therapies.
"These important findings will serve as a guidepost in the prevention of stroke in patients with PFO," said Anthony J. Furlan, MD, lead investigator of the study and Chairman of the Department of Neurology at UH Case Medical Center and Case Western Reserve University School of Medicine.
In an accompanying editorial, S. Claiborne Johnston, MD, PhD, from the University of California, San Francisco, wrote, "...CLOSURE I provides the best evidence available regarding the role of closure in stroke prevention and should not be ignored. The results of the trial do not support closure of a patent foramen ovale to prevent stroke in patients who have had a stroke or a TIA of unclear etiology."
The editorial also notes that it took nine years for the results of this trial to be reported and during that time, approximately 80,000 patients have had a PFO closed with the use of a device at an average cost of $10,000 per proced