Enterprise支架在严重症状性颅内动脉粥样硬化病变血管内治疗中的应用

doi:10.3969/j.issn.1673-5765.2020.03.009

摘要/Abstract

摘要：

目的观察超说明书Enterprise支架在严重颅内动脉粥样硬化狭窄（intracranial atherosclerotic stenosis， ICAS）病变中应用的有效性及安全性。方法回顾性纳入单中心由颅内不同部位动脉粥样硬化狭窄性或闭塞病变引起的、3个月内曾发生低灌注脑梗死或TIA的症状性患者，所有患者经DSA检查确定血管狭窄程度，狭窄率为70%～100%。给予Enterprise支架置入，采用门诊或电话随访。观察手术技术成功（前向血流mTICI 2b/3级）率、狭窄程度的变化、围手术期（术后1周内）卒中事件的发生和死亡以及远期血管再狭窄率。结果共纳入36例患者，34例为≥70%的狭窄性病变，2例为闭塞病变。36例患者共置入Enterprise支架 38枚，其中2例串联病变置入支架4枚。手术技术成功率94.44%（34/36），狭窄率从（89.21±5.13）% 减至（23.56±3.57）%（P =0.021）。围手术期缺血性卒中2例（5.6%），均为穿支病变。平均随访 12.37±3.11个月，无死亡及复发病例。20例（55.56%）患者于术后18.25±2.13个月复查了头颅CTA，其中 1例基底动脉及椎动脉V4段串联病变者，术后8个月CTA复查显示V4残余狭窄消失，但基底动脉残余狭窄加重约20%，其余患者残余狭窄均消失。结论 Enterprise支架用于动脉粥样硬化性颅内动脉狭窄性病变的治疗可能是安全、有效的，但仍需随机对照研究证实。

文章导读： 介入材料是介入手术成功的基础，超说明书材料的研发，或许能给临床医生提供更多、更便捷的选择。本文研究证实了Enterprise支架应用于症状性颅内动脉狭窄的治疗是安全有效的。

关键词: 颅内动脉狭窄; 动脉粥样硬化; Enterprise支架

Abstract:

Objective To observe the efficacy and safety of the off-label Enterprise stent in the treatment of intracranial atherosclerotic stenosis (ICAS). Methods This was a retrospective single-center study, which included symptomatic patients with hypoperfusion cerebral infarction or TIA within 3 months of onset that were caused by atherosclerotic stenosis or occlusion in different segments of intracranial arteries. The degree of stenosis was 70% to 100% by DSA. The Enterprise stent was implanted; all patients were followed up by telephone or outpatient visits. The observation measures included the success rate of surgical technique, the change of stenosis degree, the occurrence of perioperative stroke events and death, and the rate of long-term restenosis. Results A total of 36 patients were included, including 34 with stenosis ≥70% and 2 with occlusive lesions. A total of 38 Enterprise stents were placed in 36 patients, and 4 stents were placed in 2 cases with tandem lesions. The surgical technique success rate was 94.44%, and the stenosis rate decreased from (89.21±5.13)% to (23.56±3.57)% (P =0.021). Perioperative ischemic stroke occurred in 2 cases (5.6%), both of them were perforating branch lesions. The average follow-up time was 12.37±3.11 months, and there were no death or recurrence during follow-up. 20 patients (55.56%) underwent CTA re-examination, and the average imaging follow-up time were 18.25±2.13 months after operation. Of whom, in one patient with basilar artery and V4 tandem lesions, the residual stenosis in V4 segment disappeared and the residual stenosis in basilar artery increased by about 20% at 8 months after surgery, and all the residual stenosis disappeared in the remaining patients. Conclusions Enterprise stent is safe and effective in the treatment of atherosclerotic intracranial artery stenosis. However, future randomized controlled trials are needed for further vertification.

Key words: Intracranial stenosis; Atherosclerosis; Enterprise stent

赵莉莉，吕涛，李也，张倩，李晓会，江毓，王虎清，王小雅，吴宇伦，坚雅婷，孙曼，党美娟，李涛，张磊，姚丽，展淑琴，张桂莲. Enterprise支架在严重症状性颅内动脉粥样硬化病变血管内治疗中的应用[J]. 中国卒中杂志, 2020, 15(03): 275-281.

ZHAO Li-Li, LYU Tao, Li Ye,ZHANG Qian, LI Xiao-Hui, JIANG Yu, WANG Hu-Qing, WANG Xiao-Ya, WU Yu-Lun, JIAN Ya-Ting, SUN Man,DANG Mei-Juan, LI Tao, ZHANG Lei, YAO Li, ZHAN Shu-Qin, ZHANG Gui-Lian. Enterprise Stent for Severe Symptomatic Intracranial Atherosclerotic Stenosis[J]. Chinese Journal of Stroke, 2020, 15(03): 275-281.

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