VISSIT Does Not Support Balloon-Expandable Intracranial Stenting for Stroke

March 24, 2015—Findings from the VISSIT (Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial were published by Osama O. Zaidat, MD, et al in the Journal of the American Medical Association (JAMA; 2015;313:1240–1248). VISSIT studied the effect of a balloon-expandable intracranial stent (Pharos Vitesse neurovascular stent system, Codman Neuro, part of DePuy Synthes Companies of Johnson & Johnson) versus medical therapy on the risk of stroke in patients with symptomatic intracranial stenosis.

The investigators found that in patients with symptomatic intracranial stenosis (≥ 70%), the use of a balloon-expandable stent compared with medical therapy resulted in an increased 12-month risk of added stroke or transient ischemic attack (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, concluded the VISSIT investigators.

As summarized in JAMA, the VISSIT trial is an international, multicenter, 1:1-randomized, parallel group trial that enrolled patients at 27 sites from January 2009 to June 2012. The last follow-up was conducted in May 2013. The study’s sponsor halted enrollment 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 VISSIT study’s 112 patients were randomized to receive balloon-expandable stent plus medical therapy (stent group; n = 59) or medical therapy alone (medical group; n = 53).

The 30-day primary safety endpoint (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) occurred in more patients in the stent group versus the medical group (24.1% vs 9.4%), but intracranial hemorrhage within 30 days occurred in 8.6% of patients in the stent group versus none in the medical group. Additionally, the 1-year primary outcome (a composite of stroke in the same territory within 12 months of randomization or hard TIA in the same territory during day 2 through month 12) occurred in more patients in the stent group compared with the medical group (36.2% vs 15.1%), and worsening of baseline disability score (modified Rankin Scale) occurred in more patients in the stent group than in the medical group (24.1% vs 11.3%). The EuroQol-5D measurement showed no difference in any of the five dimensions between groups at 12-month follow-up, reported the VISSIT investigators in JAMA.