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VISSIT: Balloon-expandable stent associated with worse outcomes than medical therapy
For patients with symptomatic intracranial arterial stenosis, use of a balloon-expandable stent resulted in higher risk for stroke or transient ischemic attack compared with medical therapy, according to data from the VISSIT randomized clinical trial.
“These findings do not support the use of a balloon-expandable stent for patients with symptomatic intracranial arterial stenosis,” Osama O. Zaidat, MD, MS, and colleagues wrote in JAMA.
The randomized, parallel-group group trial included 59 patients assigned to balloon-expandable stent plus medical therapy and 53 assigned to medical therapy alone. Patients were randomly assigned at 27 international sites from January 2009 to June 2012.
“Upon consideration of the poor outcome associated with stenting in the SAMMPRIS trial, an early unplanned analysis was performed by the sponsor and trial enrollment was then terminated due to the low likelihood of detecting superiority of stenting over medical therapy with the current trial design,” Zaidat and colleagues wrote.
In total, 112 patients of the planned sample size of 250 were enrolled in VISSIT.
The primary outcome was a composite of stroke occurring in the same territory within 12 months of randomization or hard TIA in the same territory from day 2 through 12 months. At 12 months, this outcome had occurred in 36.2% (95% CI, 24-49.9) of the stent group vs. 15.1% (95% CI, 6.7-27.6) of the medical therapy group (P = .02).
The primary safety outcome, a composite of stroke, death or intracranial hemorrhage within 30 days of randomization and hard TIA within days 2 and 30 of randomization, occurred in 24.1% (95% CI, 13.9-37.2) of the stent group vs. 9.4% (95% CI, 3.1-20.7) of the medical therapy group (P = .05). Intracranial hemorrhage within 30 days of randomization occurred in more patients assigned stenting (8.6%; 95% CI, 2.9-19 vs. 0%; 95% CI, 0-5.5).
Patients assigned stenting had more evidence of worsening of baseline disability score on the modified Rankin scale compared with those assigned medical therapy (24.1%; 95% CI, 13.9-37.2 vs. 11.3%; 95% CI, 4.3-23). At 12 months, there was no difference between the groups with regard to any of the five dimensions of the EuroQol-5D score. – by Rob Volansky
Disclosure: Zaidat reports consulting for Codman and Shurtleff.