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stroke prevention study medication plus lifestyle changes safer than stenting

Staff Report

The final results of a stroke prevention study in patients with a narrowed brain artery confirms 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 Oct. 26 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 held in Houston.

The study, led by researchers at 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.

Chimowitz


“We knew from the early trial results 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 and a lead author, Marc Chimowitz, MBChB, professor, Department of Neurology.

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 NIH, 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 trial results were published, the FDA narrowed the criteria for the stent used in this trial (the Wingspan stent) to patients with at least a 70 percent blockage who had already had two previous strokes while undergoing aggressive medical management.

While the Sammpris trial did not compare stenting with medical therapy specifically in patients who already suffered two strokes while undergoing aggressive medical therapy, the study did compare stenting with medical therapy in several subsets of patients and did not identify any that benefited more from stenting.

November 7, 2013
 
 
 

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