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(Stroke. 2009;40:3552.)
© 2009 American Heart Association, Inc.

Original Contributions

First Food and Drug Administration-Approved Prospective Trial of Primary Intracranial Stenting for Acute Stroke

SARIS (Stent-Assisted Recanalization in Acute Ischemic Stroke)

From the Department of Neurosurgery (E.I.L., A.H.S., A.C., K.V.S., E.F.H., L.N.H.), Toshiba Stroke Research Center (E.I.L., A.H.S., A.C., K.V.S., E.F.H., L.N.H.), and Department of Radiology (E.I.L., A.H.S., L.N.H.), School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, NY; Department of Neurosurgery (E.I.L., A.H.S., A.C., K.V.S., E.F.H., L.N.H.), Millard Fillmore Gates Hospital, Kaleida Health, Buffalo, NY; Department of Neurological Surgery (D.J.F.), Stony Brook University Medical Center, Stony Brook, NY; and Department of Neurosurgery (J.M.), University of Florida, Gainesville, Fla.

Correspondence to Elad I. Levy, MD, University at Buffalo Neurosurgery, 3 Gates Circle, Buffalo NY 14209. E-mail elevy{at}ubns.com

Background and Purpose— Acute revascularization is associated with improved outcomes in ischemic stroke patients. However, it is unclear which method of intraarterial intervention, if any, is ideal. Numerous case series and cardiac literature parallels suggest that acute stenting may yield high revascularization levels with low associated morbidity. We therefore conducted a Food and Drug Administration-approved prospective pilot trial to evaluate the safety of intracranial stenting for acute ischemic stroke.

Methods— Eligibility criteria included presentation 8 hours after stroke onset, age 18 years or older, National Institutes of Health Stroke Scale score 8, angiographic demonstration of focal intracerebral artery occlusion 14 mm, and either contraindication to intravenous tissue plasminogen activator or failure to improve 1 hour after intravenous tissue plasminogen activator administration. Exclusion criteria included known hemorrhagic diathesis or coagulopathy, platelet count <100 000, intracranial hemorrhage, blood glucose level of <51 mg/100 mL, or CT perfusion imaging demonstrating more than one-third at-risk territory with nonsalvageable brain (low cerebral blood volume). Data are presented as mean±SD.

Results— Twenty patients were enrolled (mean age, 63±18 years;14 women). Mean presenting National Institutes of Health Stroke Scale was 14±3.8 (median 13). Presenting thrombolysis in myocardial infarction score was 0 (85% of patients) or 1 (15%). Recanalization to thrombolysis in myocardial infarction score of 3 (60% of patients) or 2 (40% of patients; P<0.0001) was achieved. One (5%) symptomatic and 2 (10%) asymptomatic intracranial hemorrhages occurred. At 1-month follow-up, a modified Rankin scale score of 3 was achieved in 12 of 20(60%) patients and a modified Rankin scale score of 1 was achieved in 9 of 20 (45%) patients.

Conclusion— This Food and Drug Administration-approved prospective study suggests primary intracranial stenting for acute stroke may be a valuable addition to the stroke treatment armamentarium.

Key Words: acute ischemic occlusion • intracranial stent • stroke • Wingspan system