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Stents for Symptomatic Intracranial Disease | Journal Scan
Study Questions:
What is the comparative efficacy and safety of stents versus medical therapy for patients with symptomatic intracranial stenosis?
Methods:
The authors reported data from the VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial. This international, multicenter trial randomized 112 patients to receive balloon-expandable stent plus medical therapy (stent group; n = 59) or medical therapy alone (medical group; n = 53). The primary outcome measure was a composite of stroke in the same territory within 12 months of randomization or hard transient ischemic attack (TIA) in the same territory on day 2 through month 12 post-randomization. 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. The primary safety measure was 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:
The study was prematurely halted due to futility concerns. The 30-day primary safety endpoint was more frequent in the stent arm (24.1% vs. 9.4%, p = 0.05). Intracranial hemorrhage within 30 days was also more frequent in the stent arm (8.6% vs. 0%, p = 0.06). The 1-year primary outcome of stroke or hard TIA occurred in more patients in the stent group (36% vs. 15%, p = 0.02). Worsening of baseline disability score (modified Rankin Scale) occurred in more patients in the stent group (24.1% vs. 11.3%, p = 0.09).
Conclusions:
The authors concluded that stenting for symptomatic intracranial stenosis was associated with worse outcomes compared with medical therapy.
Perspective:
The Food and Drug Administration currently restricts the self-expanding stent use to patients younger than 80 years, and refractory to medical therapy with two strokes while receiving medical therapy and 7 days following the qualifying events. The results of this study, combined with the findings from the SAMMPRIS study, clearly demonstrate the superiority of medical therapy over stenting for intracranial stenosis, and stenting should only be considered in the high risk subgroup of patients who remain symptomatic despite good medical therapy.
Keywords: Intracranial Hemorrhages, Ischemic Attack, Transient, Brain Ischemia, Stents, Stroke, Constriction, Pathologic, Medical Futility, Health Status, Outcome Assessment, Health Care, Random Allocation, United States Food and Drug Administration
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