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)

Elad I. Levy, Maryam Rahman, Alexander A. Khalessi, Patrick T. Beyer, Sabareesh K. Natarajan, Mary L. Hartney, David J. Fiorella, L. Nelson Hopkins, Adnan H. Siddiqui, J. Mocco

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44 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)915-920
Number of pages6
JournalNeurosurgery
Volume69
Issue number4
DOIs
StatePublished - Oct 2011
Externally publishedYes

Keywords

  • Acute ischemic occlusion
  • Intracranial stent
  • Stroke
  • Wingspan system

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