When the arteries that supply blood to the brain become narrowed by the build-up of the waxy substance called plaque, skyrocketing the risk for stroke, surgery is the best and safest way to treat the problem, according to European stroke researchers.
They studied more than 1,700 patients who were developing symptoms such as "swishing in the ears" or vision problems caused by a condition called carotid artery stenosis. They treated half of the patients with a surgery called endarterectomy, and the other half received flexible mesh tubes used to prop open the vessels.
They analyzed the result in a pair of studies published online by the journal Lancet Neurology and reported that patients who received the stents had a much higher rate of stroke, heart attack, and death than the surgery patients.
Moreover, researchers at seven of the 50 centers involved in the study conducted imaging studies of the brain using MRI, which allowed them to get a snapshot of the brain before the procedure and again after the procedure. Those images revealed that half of the stent patients developed a new area of brain damage after receiving the stent. These new areas of damage, called brain lesions, were seen in only 17 percent of the surgery patients.
The results of the European study were released just 15 hours before the long-anticipated results of a National Institute of Neurological Disorders and Stroke (NINDS) study, which also compared carotid stenting to endarterectomy.
The results of that trial will be released Friday morning in San Antonio, where more than 4,000 stroke experts are gathered for the American Stroke Association meeting.
Dr. Ralph Sacco, a stroke neurologist from the Miller School of Medicine at the University of Miami who is also president-elect of the American Heart Association, told MedPage Today that the European results, which were originally reported last year at a stroke meeting in Europe, were not surprising since the study enrolled patients with symptomatic carotid stenosis -- a group that is generally considered higher risk than asymptomatic patients. He noted that the U.S. study enrolled symptomatic and asymptomatic patients.
Sacco also said that the European findings might not apply to U.S. patients because both surgical techniques and hardware (carotid stents used) are "often different in Europe." For example, the European study allowed doctors to use any stent approved by European licensing authorities. In the U.S. study, the same stent -- the Acculink Carotid Stent System made by Abbott -- was used in all patients.
Dr. Larry Goldstein, director of the Duke Stroke Center in Durham, N.C., said that patient selection might explain the poor the outcomes for cartid artery stenting, since a series of earlier studies of patients with symptomatic disease had similar results.
In a commentary that accompanied both new studies, Dr. Kause Gröschel of the George August University in Göttingen, Germany, wrote that the results of European study should not be interpreted simply as a contest between stenting and endarterectomy in which a winner will be declared.
"Stenting and endarterectomy could both have their place as different treatment options for carotid stenosis and should preferably complement each other, with advantages of either technique in certain patient subgroups, which each need to be identified," Gröschel wrote.