Brain stent treatments do not offer stroke patients increased protection from strokes, according to an emerging study.As a matter-of-fact, patients who undergo aggressive medical therapy alone tend to better avoid a second stroke versus patients who undergo medical therapy and are implanted with a brain stent, said USA Today.
The trial looking into the device was halted when data indicated that stent patients died more frequently and suffered more strokes that patients receiving therapy alone, said USA Today.
Medical therapy involved taking the blood thinners Plavix (clopidogrel) and aspirin as well as blood pressure and cholesterol medications. Medical therapy also involved taking part in a lifestyle modification program that involved smoking cessation, increasing exercise, diabetes and cholesterol control, said USA Today. The federal study reviewed the Gateway-Wingspan system, said The Washington Post. The device was modeled after the stents used on heart patients and was approved in 2005.
An independent panel reviewing the trial stopped the research early in April when it became obvious that stent patients were dying more frequently than nonstent patients. The results appeared in an early edition of the New England Journal of Medicine yesterday over concerns about immediate public health issues, noted The Post.
â€œWithout the trial, this procedure seemed destined to become the standard of care,â€ said H. Gilbert Welch, a professor of medicine at the Dartmouth Institute for Health Policy & Clinical Practice, reported The Post. â€œWith it, we have another example in which the best medical care is not the most medical care,â€ he added.
The Gateway-Wingspan device opens a narrowed artery in the brain via a tiny balloon, explained The Post. The device then opens the passageway with a tiny expanding mesh scaffolding. Annually, some 90,000 Americans suffer the type of stroke the Gateway-Wingspan was developed to prevent, noted The Post.
The U.S. Food and Drug Administration (FDA) approved the device based on a small study that suggested the stent might help prevent second strokes by implanting the stent into the narrowed arteries of their brains, said The Post. “We hypothesized that stenting would be more effective than medical therapy and found exactly the opposite,” said lead researcher Dr. Marc I. Chimowitz, a professor of neurology at the Medical University of South Carolina, reported USA Today. “In this population, given the results of the study, I would recommend aggressive medical management,” he added.
Chimowitz stopped the procedure based on the results of the trial, entitled the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study, said USA Today.
Researchers randomly assigned 451 stroke patientsâ€”aged 30-80, in the highest risk groups for stroke, and with an artery block or narrowing of 70-99 percentâ€”to either aggressive medical treatment or medical treatment with brain stent implantation. It was believed stenting would reduce recurrent stroke or death by 35 percent over two years, said USA Today. Patients with less severe blockage only received medical therapy. Of the stent group, 14.7 percent died or suffered a stroke within one month after treatment, versus 5.8 percent in the group receiving medical therapy alone, said USA Today. In under one year of follow-up, 20.5 percent of the stented patients died or suffered a stroke, versus 11.5 percent in the nonstent group, said the researchers, wrote USA Today.