1 Deaths, Strokes Halt Brain-Stent Study (Newsday)
Originally published: September 13, 2011 7:55 PM
Updated: September 13, 2011 10:09 PM
By Delthia Ricks
Stony Brook University Medical Center and 49 other institutions have halted a large national stroke-prevention study of an experimental brain stent because of the high number of strokes and deaths among those who received it.
Only six Stony Brook patients received the implant, and none were adversely affected. But, as a result of the study, doctors will not offer it to patients at high risk of recurrent stroke and will prescribe them medication only.
A stent is a tiny mesh-like tube placed into a plaque-obstructed vessel. Stents are routinely used to open coronary arteries. They are also placed in carotid arteries to enhance blood flow to the brain. However, devices in the study halted last week—Gateway®-Wingspan™ stents—are different. They were designed for chronic narrowing of tiny vessels in the brain, a condition seen in virtually anyone, but most often diagnosed in African-Americans, Hispanics and Asians. The narrowing can cause the type of mini-stroke known as a transient ischemic attack.
"Certainly for these patients the data shows this was not the best thing to do," said Dr. David Fiorella, a Stony Brook interventional neuroradiologist, who led the local arm of the research, sponsored by the National Institutes of Health.
Fiorella and his colleagues are now trying to figure out why so many people fared poorly with the implant. In the trial of 451 patients, half got the device and half got medication. Thirty-three people or 15 percent of those with the device had a stroke within the first 30 days of receiving it. Five people died. By comparison, 13 patients or 5.8 percent of those on medical therapy -- daily doses of the blood thinners Plavix and aspirin -- had a recurrent stroke and only one died, but not from a stroke.
Doctors not connected with the research say the findings, published in the online edition of the New England Journal of Medicine, ends the marketability of the stent.
"I would not have wanted to be involved in that study," said Dr. David Langer, Director of Cerebrovascular Research at the Cushing Neuroscience Institute of the North Shore-LIJ Health System. "The truth is, a lot of people who believe in intracranial stents are probably disappointed."
Developed by Boston Scientific, the stent was federally approved on a humanitarian exemption in 2005 for people who had experienced a stroke, but failed drug therapy to prevent a second attack. The exemption, based on initially promising but limited data, did not require the stent's makers to provide extensive research.
Dr. Walter Koroshetz, deputy director of the National Neurological Disorders and Stroke Institute, said the new study is the first rigorous examination of the device.
"Although technological advances have brought intracranial stenting into practice, we have now learned that, when tested in a large group, this particular device did not lead to a better health outcome," he said.