TY - JOUR
T1 - Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis
T2 - The VISSIT randomized clinical trial
AU - Zaidat, Osama O.
AU - Fitzsimmons, Brian Fred
AU - Woodward, Britton Keith
AU - Wang, Zhigang
AU - Killer-Oberpfalzer, Monika
AU - Wakhloo, Ajay
AU - Gupta, Rishi
AU - Kirshner, Howard
AU - Megerian, J. Thomas
AU - Lesko, James
AU - Pitzer, Pamela
AU - Ramos, Jandira
AU - Castonguay, Alicia C.
AU - Barnwell, Stanley
AU - Smith, Wade S.
AU - Gress, Daryl R.
N1 - Publisher Copyright:
Copyright 2015 American Medical Association. All rights reserved.
PY - 2014/3/24
Y1 - 2014/3/24
N2 - 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.
AB - 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.
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U2 - 10.1001/jama.2015.1693
DO - 10.1001/jama.2015.1693
M3 - Article
C2 - 25803346
AN - SCOPUS:84925393744
SN - 0098-7484
VL - 313
SP - 1240
EP - 1248
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 12
ER -