Study: High-Risk Stroke Patients without Stents had Fewer Second Strokes
Stony Brook the Only Participating Site on Long Island in the NIH-Sponsored Clinical Trial
STONY BROOK, N.Y
., September 8, 2011
– Specialists in Stony Brook University School of Medicine’s Departments of Neurology and Neurological Surgery took part in a nationwide National Institutes of Health (NIH)-sponsored clinical trial, the results of which showed that 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. The Stenting versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study, reported in the online first edition of the
New England Journal of Medicine
, included 451 patients at 50 sites across the U.S. Stony Brook is the only site on Long Island involved in the study and one of four in New York State.
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 percent over two years.
“The early study results indicated something we did not expect,” says David Fiorella, M.D., Ph.D., 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,” adds Dr. Fiorella, also 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 U.S. Food and Drug Administration for patients with intracranial blockages at risk for stroke.
At the 30-day mark, 14.7 percent (33) of the patients in the stenting group experienced a stroke or died within that period after enrollment. This compared with 5.8 percent (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 percent of the patients in the stenting group and 11.5 percent of those in the medical treatment alone group had a stroke or death, or another stroke in the same area of the brain beyond 30 days.
These early results prompted the National Institute of Neurological Disorders and Stroke (NINDS), the arm of the NIH that funded the trial, to stop enrollment in the study. The NIH also issued a clinical alert. All patients in the trial will continue to be followed for two years to determine any long-term effects of both interventions.
“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,” says 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. “This group includes up to five-to-ten percent 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.”
Twelve patients from Stony Brook’s CVC were enrolled in the clinical trial. An independent credentialing committee reviewed each potential site participant, and the CVC was approved for participation in the trial because of expertise in cerebrovascular intervention and case volume. The Stony Brook physicians emphasize that patients enrolled were in the highest risk category for stroke, with 70 to 99 percent blockage of their intracranial arteries.
“Studying new technologies and procedures to advance the field of cerebrovascular intervention includes participating in well-designed, multicenter clinical trials such as SAMMPRIS,” emphasizes Dr. Fiorella. “Regardless of results, these trials help to refine our knowledge to optimize our ability to care for patients. We hope to continue to help lead the way with respect to the design and implementation of such clinical trials on local and national levels.”
“Taking part in large clinical trials such as SAMMPRIS helps to direct our management of stroke patients,” adds Laura Donarummo, M.D., Assistant Professor, Department of Neurology, Stony Brook University School of Medicine, and Neurology Principal Investigator for the Stony Brook clinical trial site. “The goal as a neurologist in caring for stroke patients is to always take the best measures to prevent second stroke and any related neurological events.”
Regarding explanations as to why the high-risk stroke patients who had a stent implanted had a higher rate of second stoke, Dr. Fiorella says that reasons are unclear at this point and could be multi-causal.
“One possible explanation for the higher stroke rate in the stented group is that patients who have had recent stroke symptoms sometimes have unstable plaque in their arteries. This plaque may embolize distally or occlude regional perforating vessels after angioplasty and stenting,” explains Dr. Fiorella.
SAMMPRIS is the first stroke prevention trial to compare intracranial stenting with medical therapy and incorporate intensive medical management to the study design. Patients in the study were ages 30 to 80 years old and had experienced a recent transient ischemic attack or another type of non-disabling stroke. All patients participated in a lifestyle modification program focused on quitting smoking, increasing exercise, and controlling diabetes and cholesterol.
About the Cerebrovascular and Stroke Center at Stony Brook University Medical Center
Part of Stony Brook’s Institute for Advanced Neurosciences and a collaboration of the Departments of Neurology and Neurological Surgery, the Cerebrovascular and Stroke Center (CVC) has a dedicated team of physicians, nurses, physician assistants and radiology technologists with the expertise needed to diagnose and treat the complete range of cerebrovascular diseases including arteriovenous malformations, arteriovenous fistulas, hemorrhagic strokes, ischemic strokes, atherosclerosis, and carotid stenosis. The multidisciplinary team of neurologists, interventional neuroradiologists, neuro-anestesiologists and neurosurgeons are committed to excellence in patient care, research, and education.
The CVC is home to an active clinical trials unit supported by two clinical research nurses and a National Institutes of Health funded engineering and tissue laboratory. The Center enrolls patients or participates in virtually all of the major trials that are currently underway in the U.S. As a result, patients have access to a wide variety of experimental devices that are available only through a research trial or on a "compassionate use" basis to patients who have otherwise untreatable conditions.
In addition to the multidisciplinary expertise of the clinical team and the vast array of treatment techniques and devices, the CVC includes multi-million dollar state-of-the-art bi-plane angiography suites, and high speed computed tomography (CT) and magnetic resonance imaging (MRI) facilities.