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

摘要: Importance Intracranial stenosis is one of the most common etiologies stroke. To our knowledge, no randomized clinical trials have compared balloon-expandable stent treatment with medical therapy in symptomatic intracranial arterial stenosis. Objective evaluate efficacy and safety plus vs alone patients (≥70%). Design, Setting, Patients VISSIT (the Vitesse Stent Study for Ischemic Stroke Therapy) trial an international, multicenter, 1:1 randomized, parallel group that enrolled from 27 sites (January 2009-June 2012) last follow-up May 2013. Interventions (N = 112) were to receive (stent group; n = 59) or (medical n = 53). Main Outcomes Measures Primary outcome measure: a composite stroke same territory within 12 months randomization hard transient ischemic attack (TIA) day 2 through month postrandomization. A TIA was defined as episode neurological dysfunction caused by focal brain retinal ischemia lasting at least 10 minutes but resolving 24 hours. any stroke, death, hemorrhage 30 days between randomization. Disability measured modified Rankin Scale general health status EuroQol-5D, both 12. Results Enrollment halted sponsor after negative results another prompted early analysis outcomes, which suggested futility 112 planned sample size 250 enrolled. The 30-day primary end point occurred more (14/58; 24.1% [95% CI, 13.9%-37.2%]) (5/53; 9.4% 3.1%-20.7%]) ( P  = .05). (5/58; 8.6% 2.9%-19.0%]) none (95% 0%-5.5%)  = .06). 1-year (21/58; 36.2% 24.0-49.9]) (8/53; 15.1% 6.7-27.6])  = .02). Worsening baseline disability score (modified Scale) (6/53; 11.3% 4.3%-23.0%])  = .09).The EuroQol-5D showed difference 5 dimensions groups 12-month follow-up. Conclusions Relevance Among stenosis, use resulted increased risk added territory, TIA. These findings do not support Trial Registration clinicaltrials.gov Identifier:NCT00816166.