Department of Neurosurgery, Xuanwu Hospital, Beijing, China.
Neuroendovascular Program, Massachusetts General Hospital, Boston, Massachusetts, USA.
Stroke Vasc Neurol. 2022 Apr;7(2):166-171. doi: 10.1136/svn-2021-000979. Epub 2021 Oct 12.
The safety outcomes of endovascular therapy for intracranial artery stenosis in a real-world stetting are largely unknown. The Clinical Registration Trial of Intracranial Stenting for Patients with Symptomatic Intracranial Artery Stenosis (CRTICAS) was a prospective, multicentre, real-world registry designed to assess these outcomes and the impact of centre experience.
1140 severe, symptomatic intracranial arterial stenosis (ICAS) patients treated with endovascular therapy were included from 26 centres, further divided into three groups according to the annual centre volume of intracranial angioplasty and stent placement procedures over 2 years: (1) high volume for ≥25 cases/year; (2) moderate volume for 10-25 cases/year and (3) low volume for <10 cases/year.
The rate of 30-day stroke, transient ischaemic attack or death was 9.7% (111), with 5.4%, 21.1% and 9.7% in high-volume, moderate-volume and low-volume centres, respectively (p<0.05). Multivariable logistic regression confirmed high-volume centres had a significantly lower primary endpoint compared with moderate-volume centres (OR=0.187, 95% CI: 0.056 to 0.627; p≤0.0001), while moderate-volume and low-volume centres showed no significant difference (p=0.8456).
Compared with the preceding randomised controlled trials, this real-world, prospective, multicentre registry shows a lower complication rate of endovascular treatment for symptomatic ICAS. Non-uniform utilisation in endovascular technology, institutional experience and patient selection in different volumes of centres may have an impact on overall safety of this treatment.
在真实环境中,血管内治疗颅内动脉狭窄的安全性结果在很大程度上尚不清楚。临床注册试验颅内血管成形术和支架置入术治疗有症状颅内动脉狭窄患者(CRTICAS)是一项前瞻性、多中心、真实世界的登记研究,旨在评估这些结果以及中心经验的影响。
从 26 个中心纳入 1140 例接受血管内治疗的严重、有症状颅内动脉狭窄(ICAS)患者,根据 2 年内颅内血管成形术和支架置入术的中心年容量进一步分为三组:(1)高容量(≥25 例/年);(2)中容量(10-25 例/年)和(3)低容量(<10 例/年)。
30 天卒中、短暂性脑缺血发作或死亡的发生率为 9.7%(111 例),高容量、中容量和低容量中心的发生率分别为 5.4%、21.1%和 9.7%(p<0.05)。多变量逻辑回归证实,与中容量中心相比,高容量中心的主要终点发生率显著降低(OR=0.187,95%CI:0.056 至 0.627;p≤0.0001),而中容量和低容量中心之间无显著差异(p=0.8456)。
与之前的随机对照试验相比,这项真实世界、前瞻性、多中心登记研究显示,症状性 ICAS 血管内治疗的并发症发生率较低。不同容量中心在血管内技术的应用、机构经验和患者选择方面的非一致性可能对该治疗的整体安全性产生影响。