Expensive procedure no more effective than medical therapy to prevent strokes

A catheter procedure that closes a hole in patients' hearts was 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 stroke or TIA and a patent foremen ovale (PFO) -- a hole between the heart's two upper chambers. In the international, multi-site study led by University Hospitals 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.