Abstract
BACKGROUND: The high rate of periprocedural complications for the endovascular stent procedure in the Stenting Versus Aggressive Medical Management Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial resulted in it being less recommended than medical therapy to treat intracranial atherosclerotic stenosis (ICAS). Because Enterprise stent use might reduce the incidence of complications in ICAS treatment compared to other frequently used stents, this paper evaluated the safety and effectiveness of the Enterprise stent for the treatment of ICAS. METHODS: We performed a comprehensive literature search for reports on intracranial angioplasty using the Enterprise stent for ICAS treatment from the earliest date available from each database to May 2020 for PubMed, EMBASE, Web of Science, Cochrane, and Clinical Trials databases. We also reviewed the single-center experience of the First Affiliated Hospital of Harbin Medical University. We extracted information regarding periprocedural complications, procedure-related morbidity, mortality, immediate angiographic outcome, and long-term clinical and angiographic outcomes, among others. Event rates were pooled across studies using random-effects or fixed-effects models depending on the heterogeneity. RESULTS: Five hundred fifty-seven patients with 588 lesions from seven studies, including the institutional series, were included in the analysis. The incidence of stroke or death within 30 days was 7.4% (95% confidence interval (CI), 5.5%-10.1%). The incidence of ischemic stroke or TIA in the territory of the qualifying artery beyond 30 days and during follow-up was 3.2% (95% CI, 1.1%-9.5%). The incidence of in-stent restenosis was 10.1% (95% CI, 4.6%-22.2%), and the incidence of symptomatic restenosis was 4.1% (95% CI, 1.7%-9.9%). CONCLUSIONS: Intracranial angioplasty utilizing the Enterprise stent for ICAS treatment was relatively safe and effective but required further verification using additional sources for evidence.