Clearing brain arteries with stent may risk stroke

Patients with clogged arteries deep in their brains are more likely to suffer a stroke if the blockages are cleared and propped open with a stent rather than treated aggressively with drugs, researchers said.

The results contradicted the investigators' hypothesis and led an independent safety panel to halt the trial early, after 451 patients enrolled. The findings are slowing use of stents inside the skull, which had been rising since the 2005 approval of the device from Boston Scientific Corp., said researcher Colin Derdeyn, an interventional neuroradiologist at Washington University School of Medicine in St. Louis.

After 30 days, 14.7 percent of patients treated with the stent in addition to a cocktail of drugs died or suffered a stroke, compared with 5.8 percent of those given only the medicines. There were few differences between the groups after the first month, with a 20 percent expected rate of death or stroke in the stent group and 12.2 percent in the medical management arm after one year.

“We've shown conclusively that if you have a tight blockage of an artery inside the brain, being treated medically is definitely the right way to go,” Derdeyn, director of the university's stroke and cerebrovascular center, said in a telephone interview. “We are following patients further, but there is statistically no chance at this point that stenting will win.”

Stroke is the fourth-leading cause of death in the United States. Stenosis, a blockage or narrowing of brain arteries caused by the buildup of plaque, accounts for more than 50,000 of the 795,000 strokes that occur annually nationwide, according to the National Institutes of Health.

The results of the study, funded by the National Institute of Neurological Disorders and Stroke, were released by the New England Journal of Medicine.

The patients all suffered a stroke or transient ischemic attack before enrolling in the study, and the condition was attributed to a clot that blocked 70 percent to 99 percent of a major intracranial artery. They were given aspirin and Plavix, an anti-clotting medicine. Patients also took Crestor, a cholesterol-lowering medication and a drug to lower blood pressure.

The results offered some positive signs, said Marc Chimowitz, the lead researcher and professor of neuroscience at the Medical University of South Carolina in Charleston.

“The good and gratifying news was that the aggressive medical management appeared to lower the risk substantially,” he said in a telephone interview. “We've made some real progress here with respect to treating these patients. It seems like this is a particularly high risk disease early, and once you get over that first hump things seem to level out.”