London, Sept 8 (ANI): A large clinical trial has found that patients at a high risk for a second stroke who received intensive medical treatment had fewer strokes and deaths than patients who received a brain stent in addition to the medical treatment.
In total, 50 medical centres participated in the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial, led by the Medical University of South Carolina in Charleston.
SAMMPRIS enrolled 451 patients at 50 sites across the United States. Half the patients in the study received a medical regimen that included daily anti-thrombotic medications and aggressive control of blood pressure and cholesterol.
The other patients in the study received an intervention of a self-expanding stent that widens a major artery in the brain and facilitates blood flow.
Researchers had hypothesized that compared with intensive medical therapy alone, the addition of an intracranial stenting system would decrease the risk of a stroke or death by 35 percent over two years.
Instead they found that 14.7 percent of patients in the stenting group experienced a stroke or died within the first 30 days after enrollment, compared with 5.8 percent of patients treated with medical therapy alone.
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 that the stent could have dislodged, the study authors suggested.
"Although technological advances have brought intracranial stenting into practice, we have now learned that, when tested in a large group, this particular device did not lead to a better health outcome," said Dr. Walter Koroshetz, deputy director of NINDS.
The results were published in the online edition of the New England Journal of Medicine. (ANI)