Osama Zaidat, MD, MS, Associate Professor of Neurology and Neurosurgery at MCW and director of the neurointerventional program at Froedtert & the Medical College of Wisconsin, is the lead author of the study, which is published in the March 24/31 issue of JAMA.
Intracranial arterial stenosis is a common cause of stroke worldwide. The recurrent stroke risk with severe symptomatic intracranial stenosis may be as high as 23 percent at 1 year, despite medical therapy, according to background information in the article.
In the study, Dr. Zaidat and his colleagues randomly assigned 112 patients with symptomatic intracranial stenosis (narrowing of 70 percent or greater) to receive a balloon-expandable stent plus medical therapy (stent group; n = 59) or medical therapy alone (medical group; n = 53). Medical therapy consisted of clopidogrel (75 mg daily) for the first 3 months after enrollment and aspirin (81-325 mg daily) for the study duration. This international trial (VISSIT) enrolled patients from 27 sites (January 2009-June 2012) with last follow-up in May 2013. Enrollment was halted by the sponsor after negative results from another trial prompted an early analysis of outcomes, which suggested futility after 112 patients of a planned sample size of 250 were enrolled.
“These findings do not support the use of a balloon-expandable stent for patients with intracranial arterial stenosis,” said Dr. Zaidat.
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