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

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

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Abstract

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). MAIN OUTCOMES AND MEASURES: 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 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 250were 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.

Original languageEnglish (US)
Pages (from-to)1240-1248
Number of pages9
JournalJAMA - Journal of the American Medical Association
Volume313
Issue number12
DOIs
StatePublished - Mar 24 2015

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ASJC Scopus subject areas

  • Medicine(all)

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Zaidat, O. O., Fitzsimmons, B. F., Woodward, B. K., Wang, Z., Killer-Oberpfalzer, M., Wakhloo, A., Gupta, R., Kirshner, H., Megerian, J. T., Lesko, J., Pitzer, P., Ramos, J., Castonguay, A. C., Barnwell, S., Smith, W. S., & Gress, D. R. (2015). 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. JAMA - Journal of the American Medical Association, 313(12), 1240-1248. https://doi.org/10.1001/jama.2015.1693