Effect of a Balloon-Expandable Intracranial Stent vs Medical Therapy on Risk of Stroke in Patients With Symptomatic Intracranial Stenosis

作者：Osama O. Zaidat, Brian‐Fred Fitzsimmons, B Woodward, Zhigang Wang, Monika Killer‐Oberpfalzer, Ajay K. Wakhloo, Rishi Gupta, Howard S. Kirshner, J. Thomas Megerian, J Lesko, Pamela Pitzer, Jandira Ramos, Alicia C. Castonguay, Stanley L. Barnwell, Wade S. Smith, Daryl R. Gress · 发表于：JAMA · 年份：2015 · DOI：10.1001/jama.2015.1693 · 被引用次数：622 · 研究领域：Cerebrovascular and Carotid Artery Diseases、Acute Ischemic Stroke Management、Moyamoya disease diagnosis and treatment

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 (≥70%). DESIGN, SETTING, AND PATIENTS: VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke 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). PRIMARY 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 an...