SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis), a large NIH funded trial comparing two methods of stroke prevention was recently published in the New England Journal of Medicine (N Engl J Med 2011; 365: 993-1003). This particular study showed that medical therapy was generally better than angioplasty with stenting for treating blood vessel narrowing in the head causing stroke.
SAMMPRIS enrolled 451 patients at 50 sites across the United States. Columbia was one of only 2 medical centers in New York City participating in the trial.
Dr. Philip Meyers from the Endovascular Center was the principle interventional investigator at Columbia and performed all the procedures for the trial. He was also a member of the credentialing committee selecting trial interventional physicians nationwide.
Patients who enrolled in the study were selected because they were all at high risk for stroke because of narrowing in brain arteries presumably due to atherosclerosis, the same disease that causes coronary artery narrowing and heart attacks. SAMMPRIS trial patients had all suffered a transient ischemic attack (TIA) or survived a recent stroke within 30 days of enrollment and exhibited severe (70-99%) blockage of a major artery to the brain. A previous trial called WASID (Warfarin-Aspirin Symptomatic Intracranial Disease trial) had shown that patients in this situation were at high risk for recurrent stroke or death within 2 years.
In SAMMPRIS, all the patients received intensive medical management including daily blood thinning medication, aggressive control of blood pressure and cholesterol. Half of the group also underwent a procedure to re-open the severely narrowed blood vessel causing the strokes with angioplasty and stenting using the Wingspan™ system (Stryker Medical, Fremont, CA), to widen the narrow vessel and to improve blood flow to the brain.
Researchers had predicted that patients receiving the stent would be less likely to have another stroke than patients receiving medicine alone.
The trial was concluded last April when a clear pattern emerged: those patients solely on medical therapy did significantly better than those who also received the stent.
Dr. Meyers says many physicians were surprised by the results of SAMMPRIS. “Although we at Columbia didn’t experience the problems stenting patients that occurred in the overall trial population, multi-center trial data is most important. The patients we treated did well. We all thought that stenting was going to be the best thing to do for these patients, but the results of the overall trial showed that it is not–medical therapy was found to be superior in SAMMPRIS. We are not entirely sure why patients in the medical arm of SAMMPRIS did so well. Apparently, modern intensive medical therapy with statins, anti-platelet drugs, and blood pressure control is clearly more effective than it has been in the past.”
The results of SAMMPRIS have caused a stir among those involved in the treatment of this type of stroke patient, not the least of which were endovascular neurosurgeons and the makers of the particular stent used in the trial.
Dr. Meyers and his colleagues in the Society of Neurointerventional Surgery (SNIS) recently met with representatives of the company that manufactures the Wingspan™ device at their recent Corporate Advisory Council meeting in Las Vegas, Nevada.
Meyers, who is currently Vice President of the SNIS, says, “The SNIS meets annually with the CEOs and senior executives of the various companies that make products we use to review important issues regarding patient care and safety, plan improvements, and make recommendations for future research and development.”
Not surprising, the results of the SAMMPRIS trial were on this year’s agenda. Meyers says, “We reviewed new approaches to intracranial revascularization and concluded that it is important to keep working on alternatives to help patients for whom medicine just isn’t working.”
Although not exactly the results we wanted, SAMMPRIS represents an important step forward in medical science. It is sure to guide many patients and physicians in their selection of therapy to prevent stroke due to severe intracranial atherosclerosis. “This is important information,” says Dr. Meyers. “As physicians, we want what is best for our patients. Scientific progress is not always simple or easy. There are many technological developments in the treatment of cerebrovascular diseases. We have to know what works and what does not to deliver excellent medical care.”
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