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Study: medication, lifestyle better than stents to prevent stroke
Contact: Tony Ciuffo
Oct. 26, 2013
CHARLESTON – The final results of a stroke prevention study in patients with a narrowed brain artery confirm earlier findings from the study: medication plus lifestyle changes are safer and more effective than a surgical technique called stenting for preventing stroke. The results appear in The Lancet today to coincide with a presentation of the study results at the joint meetings of the 6th International Conference on Intracranial Atherosclerosis and the 6th annual meeting of the Society of Vascular and Interventional Neurology being held in Houston.
The study, led by researchers at the Medical University of South Carolina (MUSC), Emory University, Washington University School of Medicine and State University of New York at Stony Brook analyzed long-term health outcomes from a multicenter clinical trial in which enrollment was halted two years ago when it became apparent that stenting was associated with a higher risk of early stroke and death.
“We knew from the early results of the trial that stenting was associated with a high risk of stroke and death in the peri-operative period but we expected stenting to be associated with a lower risk of stroke than medical therapy later on. That did not happen,” said principal investigator of the study and a lead author Marc Chimowitz, MBChB, professor of neurology at MUSC.
About 800,000 people have a stroke every year in the United States. Physicians think about 10 percent of strokes in the U.S. result from a narrowed artery inside the brain. For decades, doctors have treated these patients with medications that help prevent clot formation by thinning the blood and lowering cholesterol and blood pressure.
Recent advances in surgical techniques and tools have allowed physicians to improve blood flow in narrowed brain arteries by adapting procedures used to open clogged arteries in the heart.
To assess the effectiveness of the new treatments, the SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis) trial, which was funded by the National Institutes of Health, enrolled 451 patients at high risk of repeated stroke. All the participants had a brain artery with at least a 70 percent narrowing that had already caused a stroke or a transient ischemic event (often referred to as a mini stroke).
Participants were divided into two groups. One group had a metal stent put in the narrowed brain artery to open up the artery and received strong medications to reduce clot formation and lower cholesterol and blood pressure. Participants in the second group received the same medications but did not undergo stenting. Both groups also were contacted regularly by lifestyle modification coaches, who encouraged participants to exercise more, stop smoking, improve their diet and lose weight.
For the new analysis, the scientists followed all the patients for at least two years after treatment. Some patients were followed for as long as four years.
"The final results of the SAMMPRIS trial show that aggressive medical therapy was superior to stenting at both early and later phases of follow-up in the trial. These results strongly support the use of aggressive medical therapy rather than stenting for preventing recurrent stroke in high-risk patients with narrowing of a brain artery," added Chimowitz.
After the early results of this trial were published, the FDA narrowed the criteria for use of the stent used in this trial (the Wingspan stent) to patients with at least a 70% blockage who had already had 2 previous strokes while taking aggressive medical management. While the SAMMPRIS trial did not compare stenting with medical therapy specifically in patients who already suffered two strokes while taking aggressive medical therapy, the study did compare stenting with medical therapy in several other subsets of patients and did not identify any subset that benefited more from stenting than medical therapy.
Founded in 1824 in Charleston, The Medical University of South Carolina is the oldest medical school in the South. Today, MUSC continues the tradition of excellence in education, research, and patient care. MUSC educates and trains more than 3,000 students and residents, and has nearly 13,000 employees, including approximately 1,500 faculty members. As the largest non-federal employer in Charleston, the university and its affiliates have collective annual budgets in excess of $1.7 billion. MUSC operates a 750-bed medical center, which includes a nationally recognized Children's Hospital, the Ashley River Tower (cardiovascular, digestive disease, and surgical oncology), Hollings Cancer Center (one of 66 National Cancer Institute designated centers) and a leading Institute of Psychiatry. For more information on academic information or clinical services, visit www.musc.edu. For more information on hospital patient services, visit www.muschealth.com.