title: Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial.
abstract: OBJECTIVE
  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%).
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  METHODS
  
  
  
  METHODS
  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
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00816166.
authors: Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee2Department of Neurosurgery, Medical College of Wisconsin/Froedtert Hospital, Milwaukee3Department of Radiology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee.
authors: Osama O
authors: OO
authors: Zaidat
authors: Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee2Department of Neurosurgery, Medical College of Wisconsin/Froedtert Hospital, Milwaukee3Department of Radiology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee.
authors: Brian-Fred
authors: BF
authors: Fitzsimmons
authors: Vista Radiology, Knoxville, TN.
authors: Britton Keith
authors: BK
authors: Woodward
authors: Department of Neurology, The Second Hospital of Shandong University, Ji'nan, Shandong Province, China.
authors: Zhigang
authors: Z
authors: Wang
authors: Department of Neurology, Paracelsus Medical University, Salzburg, Austria.
authors: Monika
authors: M
authors: Killer-Oberpfalzer
authors: Department of Radiology, University of Massachusetts, Worcester.
authors: Ajay
authors: A
authors: Wakhloo
authors: Neuroscience Center, Wellstar Health System, Atlanta, Georgia.
authors: Rishi
authors: R
authors: Gupta
authors: Department of Neurology, Vanderbilt University Medical Center, Nashville, Tennessee.
authors: Howard
authors: H
authors: Kirshner
authors: Codman and Shurtleff Inc, Raynham, Massachusetts.
authors: J Thomas
authors: JT
authors: Megerian
authors: Codman and Shurtleff Inc, Raynham, Massachusetts.
authors: James
authors: J
authors: Lesko
authors: Codman and Shurtleff Inc, Raynham, Massachusetts.
authors: Pamela
authors: P
authors: Pitzer
authors: Codman and Shurtleff Inc, Raynham, Massachusetts.
authors: Jandira
authors: J
authors: Ramos
authors: Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee.
authors: Alicia C
authors: AC
authors: Castonguay
authors: Department of Neurological Surgery, Oregon Health and Science University, Portland12The Dotter Interventional Institute, Oregon Health and Science University, Portland.
authors: Stanley
authors: S
authors: Barnwell
authors: Department of Neurology, University of California-San Francisco.
authors: Wade S
authors: WS
authors: Smith
authors: Department of Neurology, University of Virginia, Charlottesville.
authors: Daryl R
authors: DR
authors: Gress
mesh_terms: D000328:Adult; D000368:Aged; D016893:Carotid Stenosis / Q000150:complications / Q000628:therapy*; D005260:Female; D006801:Humans; D020300:Intracranial Hemorrhages / Q000209:etiology; D008297:Male; D008875:Middle Aged; D012306:Risk; D015607:Stents / Q000009:adverse effects*; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome; D014715:Vertebrobasilar Insufficiency / Q000150:complications / Q000628:therapy*