Effect of a Balloon-Expandable Intracranial Stent vs Medical Therapy on Risk of Stroke in Patients With Symptomatic Intracranial Stenosis
Authors: Osama O. Zaidat, Brian-Fred Fitzsimmons, Britton Keith Woodward, Zhigang Wang, Monika Killer-Oberpfalzer, Ajay Wakhloo, Rishi Gupta, Howard Kirshner, J. Thomas Megerian, James Lesko, Pamela Pitzer, Jandira Ramos, Alicia C. Castonguay, Stanley Barnwell, Wade S. Smith, Daryl R. Gress
Journal: JAMA (2015)

IMPORTANCE Intracranial stenosis is one of the most common etiologies of stroke.To our knowledge, no randomized clinical trials have compared balloon-expandable stent treatment with medical therapy in symptomatic intracranial arterial stenosis.OBJECTIVE To evaluate the efficacy and safety of the balloon-expandable stent plus medical therapy vs medical therapy alone in patients with symptomatic intracranial stenosis (Ն70%). DESIGN, SETTING, AND PATIENTS VISSIT (the Vitesse Intracranial Stent Study for IschemicStroke Therapy) trial is an international, multicenter, 1:1 randomized, parallel group trial that enrolled patients from 27 sites (January 2009-June 2012) with last follow-up in May 2013.INTERVENTIONS Patients (N = 112) were randomized to receive balloon-expandable stent plus medical therapy (stent group; n = 59) or medical therapy alone (medical group; n = 53). MAIN OUTCOMES AND MEASURESPrimary outcome measure: a composite of stroke in the same territory within 12 months of randomization or hard transient ischemic attack (TIA) in the same territory day 2 through month 12 postrandomization.A hard TIA was 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.Primary safety measure: a composite of any stroke, death, or intracranial hemorrhage within 30 days of randomization and any hard TIA between days 2 and 30 of randomization.Disability was measured with the modified Rankin Scale and general health status with the EuroQol-5D, both through month 12.RESULTS 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 primary safety end point occurred in more patients in the stent group (14/58; 24.1% [95% CI, 13.9%-37.2%])vs the medical group (5/53; 9.4% [95% CI, 3.1%-20.7%])(P = .05).Intracranial hemorrhage within 30 days occurred in more patients in the stent group (5/58; 8.6% [95% CI, 2.9%-19.0%])vs none in the medical group (95% CI, 0%-5.5%)(P = .06).The 1-year primary outcome of stroke or hard TIA occurred in more patients in the stent group (21/58; 36.2% [95% CI, 24.0-49.9])vs the medical group (8/53; 15.1% [95% CI, 6.7-27.6])(P = .02).Worsening of baseline disability score (modified Rankin Scale) occurred in more patients in the stent group (14/58; 24.1% [95% CI, 13.9%-37.2%])vs the medical group (6/53; 11.3% [95% CI, 4.3%-23.0%])(P = .09).The EuroQol-5D showed no difference in any of the 5 dimensions between groups at 12-month follow-up.CONCLUSIONS AND RELEVANCE Among patients with symptomatic intracranial arterial stenosis, the use of a balloon-expandable stent compared with medical therapy resulted in an increased 12-month risk of added stroke or TIA in the same territory, and increased 30-day risk of any stroke or TIA.These findings do not support the use of a balloon-expandable stent for patients with symptomatic intracranial arterial stenosis.