First Food and Drug Administration-approved prospective trial of primary intracranial stenting for acute stroke: SARIS (stent-assisted recanalization in acute ischemic stroke).
OBJECTIVE
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 <or=8 hours after stroke onset, age 18 years or older, National Institutes of Health Stroke Scale score >or=8, angiographic demonstration of focal intracerebral artery occlusion <or=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 <or=3 was achieved in 12 of 20(60%) patients and a modified Rankin scale score of <or=1 was achieved in 9 of 20 (45%) patients.


CONCLUSIONS
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.
Levy
Elad I
EI
Department of Neurosurgery, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, NY 14209, USA. elevy@ubns.com
Siddiqui
Adnan H
AH
Crumlish
Annemarie
A
Snyder
Kenneth V
KV
Hauck
Erik F
EF
Fiorella
David J
DJ
Hopkins
L Nelson
LN
Mocco
J
J
D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000401:mortality / Q000601:surgery*; D002548:Cerebral Revascularization / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents; D020521:Stroke / Q000401:mortality / Q000601:surgery*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence