Use of balloon-expandable stent compared with medical therapy increases stroke risk

Among patients with symptomatic intracranial arterial stenosis (narrowing of an artery inside the brain), the use of a balloon-expandable stent compared with medical therapy (clopidogrel and aspirin) resulted in an increased of stroke or transient ischemic attack (TIA), according to a study 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.

Osama O. Zaidat, M.D., M.S., of the Medical College of Wisconsin/Froedtert Hospital, Milwaukee, and 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.

The 30-day safety end point of any stroke within 30 days or hard TIA (defined as a transient episode of neurological dysfunction caused by focal brain or retinal ischemia lasting at least 10 minutes but resolving within 24 hours) within 2 to 30 days was 9.4 percent (5/53) in the medical group and 24.1 percent (14/58) in the stent group. Ischemic stroke was observed in 3 patients (5.7 percent) in the medical group and in 10 patients (17.2 percent) in the stent group. Intracranial hemorrhage occurred in 5 patients (8.6 percent) in the stent group and in 0 in the medical group. The 1-year outcome of stroke or hard TIA occurred in more patients in the stent group (36.2 percent) vs the medical group (15.1 percent).

Thirty day all-cause death was 3 of 58 patients (5.2 percent) in the stent group and 0 in the medical group. A measure of disability worsened in more patients in the stent group than in the medical group.

"These findings do not support the use of a balloon-expandable stent for patients with intracranial arterial stenosis," the authors conclude.