(RxWiki News) Price tag doesn't always signify the success of a treatment. An expensive surgical procedure designed to prevent recurrent strokes does not appear to be any more effective than simply taking medication.
Both were found just as effective in preventing new strokes or mini strokes from unexplained causes despite the substantial difference in invasiveness and cost.
"Discuss stroke prevention treatments with a cardiologist."
Dr. Anthony J. Furlan, lead investigator of the study and chairman of the department of neurology at University Hospitals Case Medical Center and Case Western Reserve University School of Medicine, said the findings are important for patients with patent foremen ovale (PFO), a hole between the heart's two upper chambers.
During the CLOSURE I trial, 909 patients between the ages of 18 and 60 with unexplained stroke or transient ischemic attacks and PFO were enrolled in the 64-month study that ended in October 2008. Patients were enrolled at 87 medical centers in the U.S. and Canada.
Participants were randomly assigned to receive either medical therapy of 325 milligrams of aspirin, an appropriate dose of warfarin (Coumadin) or a combination of both; or medical therapy of 75 milligrams of clopidogrel (Plavix) for six months followed by 325 milligrams of aspirin for two years with PFO closure.
During the PFO closure procedure, surgeons used a device called the STARFlex Septal Closure System, which was attached to a catheter and threaded into the upper heart. The device then applied a "clamshell" patch on both sides of the hole. All patients were followed for two years.
Researchers initiated the trial expecting to find that the Starflex device was superior, but instead found no significant statistical difference between the two therapies.
Dr. Furlan said the findings indicate the hole may be coincidental with a recurrent stroke in patients with PFO. He suggests most patients with unexplained strokes could best be treated with medical therapy alone.
In an accompanying editorial, Dr. S. Claiborne Johnston, from the University of California, San Francisco, noted that during the nine-year period it took to report the trial's results, about 80,000 patients had a PFO closed, with device use cost averaging $10,000 per procedure.
"Even if only half these patients were treated by this method for the purpose of preventing stroke, it would suggest that during that period of time $400 million was spent on a procedure that had no apparent benefit, to say nothing of the potential clinical risks involved," he wrote in the editorial.
The study was published in the March 15 issue of the New England Journal of Medicine.