Department of Neurosurgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China.
Department of Neurology, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China.
Biomed Res Int. 2021 Apr 17;2021:6645500. doi: 10.1155/2021/6645500. eCollection 2021.
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.
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.
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%).
Intracranial angioplasty utilizing the Enterprise stent for ICAS treatment was relatively safe and effective but required further verification using additional sources for evidence.
血管内支架术在颅内动脉狭窄支架治疗与强化药物治疗(SAMMPRIS)试验中围手术期并发症发生率较高,因此其治疗颅内动脉粥样硬化性狭窄(ICAS)的推荐程度不及药物治疗。由于 Enterprise 支架的使用可能会降低 ICAS 治疗中并发症的发生率,因此与其他常用支架相比,本研究评估了 Enterprise 支架治疗 ICAS 的安全性和有效性。
我们对从各数据库最早可用日期至 2020 年 5 月的 PubMed、EMBASE、Web of Science、Cochrane 和临床试验数据库中关于 Enterprise 支架治疗 ICAS 的颅内血管成形术的报告进行了全面的文献检索。我们还回顾了哈尔滨医科大学第一附属医院的单中心经验。我们提取了围手术期并发症、与手术相关的发病率、死亡率、即刻血管造影结果以及长期临床和血管造影结果等信息。根据异质性,使用随机效应或固定效应模型对研究间的事件发生率进行了汇总。
纳入了来自七个研究的 557 例患者(588 处病变),包括机构系列研究。30 天内卒中或死亡的发生率为 7.4%(95%置信区间,5.5%-10.1%)。30 天后和随访期间 qualifying 动脉区域的缺血性卒中和 TIA 的发生率为 3.2%(95%置信区间,1.1%-9.5%)。支架内再狭窄的发生率为 10.1%(95%置信区间,4.6%-22.2%),症状性再狭窄的发生率为 4.1%(95%置信区间,1.7%-9.9%)。
Enterprise 支架治疗 ICAS 的颅内血管成形术相对安全有效,但需要进一步通过其他来源的证据进行验证。