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Trial gives thought to using stents
Patients at high risk for a second stroke had a lower risk of stroke and death when treated with aggressive medical therapy than patients who received a brain stent in addition to aggressive medical therapy, according to a nationwide clinical trial that included specialists in Stony Brook University School of Medicine's Departments of Neurology and Neurological Surgery, Stony Brook, NY.
The Stenting versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study,1 reported online first by The New England Journal of Medicine (NEJM), included 451 patients at 50 sites across the United States.
The clinical care, conducted in the Cerebrovascular and Stroke Center (CVC) at Stony Brook University Medical Center, included a medical regimen that consisted of daily blood-thinning medications and treatments to control high blood pressure and high cholesterol. Some patients also received a brain stent. Collectively, the NIH-supported investigators had hypothesized that compared to medical therapy alone, patients who also received an intracranial stenting system would decrease their risk of stroke or death significantly, perhaps by 35% over two years.
"The early study results indicated something we did not expect," says David Fiorella, MD, PhD, professor of clinical neurological surgery and radiology, Stony Brook University School of Medicine, one of the national co-principal investigators of SAMMPRIS, and one of the lead authors of the NEJM paper. "Within 30 days of the treatment, the stenting group had significantly higher rates of stroke and death than the non-stenting group. Therefore, we need to reassess the role of stenting in high-risk stroke populations, as it appears that stenting with the study device is detrimental to this group." Fiorella is one of three Stony Brook colleagues to collaborate on the study locally.
All of the patients in the SAMMPRIS study had high-grade symptomatic blockages of their brain arteries, and nearly half (224) received an intervention of a self-expanding stent designed to widen a major artery in the brain to improve blood flow. The study device, the Gateway-Wingspan intracranial angioplasty and stenting system, is the only system approved by the Food and Drug Administration for patients with intracranial blockages at risk for stroke.
At the 30-day mark, 14.7% (33) of the patients in the stenting group experienced a stroke or died within that period after enrollment. This statistic was compared with 5.8% (13) of the patients treated with medical therapy alone. There were five stroke-related deaths within those 30 days, all of which came from the stenting group. During a follow-up period of just less than one year, 20.5% of the patients in the stenting group and 11.5% of those in the medical treatment alone group had a stroke or died, or another stroke in the same area of the brain beyond 30 days.
Henry Woo, MD, associate professor of clinical neurological surgery and radiology, Stony Brook University School of Medicine, director of the CVC, and interventional principal investigator of the Stony Brook clinical trial site, said, "These findings are critical in our search to discover an optimal way to treat patients at Stony Brook who have the highest risk of a second stroke. This group includes up to 5-10% of stroke patients, many of whom have multiple risk factors, which complicates the process to finding the most effective way to prevent an additional stroke."