Midterm Clinical and Angiographic Follow-Up for the First Food and Drug Administration-Approved Prospective, Single-Arm Trial of Primary Stenting for Stroke: SARIS (Stent-Assisted Recanalization for Acute Ischemic Stroke)

BACKGROUND: Although early data demonstrate encouraging angiographic results following intracranial stent deployment for acute ischemic stroke, longer-term follow-up is necessary to evaluate the clinical outcomes, as well as the durability of angiographic results. OBJECTIVE: We report 6-month clinical and radiologic follow-up data of the 20 patients prospectively enrolled in the Stent-Assisted Recanalization in acute Ischemic Stroke (SARIS) trial. METHODS: Twenty patients were prospectively enrolled to receive self-expanding intra-arterial stents as first-line therapy for acute ischemic stroke treatment. Patients were scheduled for follow-up 6-months after treatment for clinical evaluation (modified Rankin Scale [mRS] score obtained by a trained certified research nurse/nurse practitioner) and repeat cerebral angiography. Angiographic interpretation was performed by an independent adjudicator. RESULTS: At 6 months, the mRS score was <= 3 in 60% of patients (n = 12) and was <= 2 in 55% of patients (n = 11). Mortality at the 6-month follow-up was 35% (n = 7). Follow-up angiography was performed for 85% (11 of 13) of surviving patients. All patients undergoing angiographic follow-up demonstrated Thrombolysis in Myocardial Infarction 3 flow on digital subtraction angiography or stent patency on computed tomographic angiography. None of the patients demonstrated evidence of in-stent stenosis (>= 50% vessel narrowing). CONCLUSION: The midterm angiographic and clinical results following intracranial stent deployment for acute ischemic stroke are encouraging. Further study of primary stent-for-stroke treatment is warranted.