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颈动脉内膜切除术与重复颈动脉血管成形术和支架置入治疗支架内再狭窄(CERCAS 试验)的比较:一项随机研究。

Comparison of carotid endarterectomy and repeated carotid angioplasty and stenting for in-stent restenosis (CERCAS trial): a randomised study.

机构信息

Department of Neuroscience, Faculty of Medicine, Univerzity of Ostrava, Ostrava, Czech Republic.

Department of Neurosurgery, University Hospital Ostrava, Ostrava, Czech Republic.

出版信息

Stroke Vasc Neurol. 2023 Oct;8(5):399-404. doi: 10.1136/svn-2022-002075. Epub 2023 Mar 27.

DOI:10.1136/svn-2022-002075
PMID:36972920
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10648045/
Abstract

BACKGROUND AND AIM

In-stent restenosis (ISR) belongs to an infrequent but potentially serious complication after carotid angioplasty and stenting in patients with severe carotid stenosis. Some of these patients might be contraindicated to repeat percutaneous transluminal angioplasty with or without stenting (rePTA/S). The purpose of the study is to compare the safety and effectiveness of carotid endarterectomy with stent removal (CEASR) and rePTA/S in patients with carotid ISR.

METHODS

Consecutive patients with carotid ISR (≥80%) were randomly allocated to the CEASR or rePTA/S group. The incidence of restenosis after intervention, stroke, transient ischaemic attack myocardial infarction and death 30 days and 1 year after intervention and restenosis 1 year after intervention between patients in CEASR and rePTA/S groups were statistically evaluated.

RESULTS

A total of 31 patients were included in the study; 14 patients (9 males; mean age 66.3±6.6 years) were allocated to CEASR and 17 patients (10 males; mean age 68.8±5.6 years) to the rePTA/S group. The implanted stent in carotid restenosis was successfully removed in all patients in the CEASR group. No clinical vascular event was recorded periproceduraly, 30 days and 1 year after intervention in both groups. Only one patient in the CEASR group had asymptomatic occlusion of the intervened carotid artery within 30 days and one patient died in the rePTA/S group within 1 year after intervention. Restenosis after intervention was significantly greater in the rePTA/S group (mean 20.9%) than in the CEASR group (mean 0%, p=0.04), but all stenoses were <50%. Incidence of 1-year restenosis that was ≥70% did not differ between the rePTA/S and CEASR groups (4 vs 1 patient; p=0.233).

CONCLUSION

CEASR seems to be effective and save procedures for patients with carotid ISR and might be considered as a treatment option.

TRIAL REGISTRATION NUMBER

NCT05390983.

摘要

背景与目的

血管内支架成形术后再狭窄(ISR)是严重颈动脉狭窄患者颈动脉血管成形术和支架置入术后一种罕见但潜在严重的并发症。部分患者可能不适合重复经皮腔内血管成形术伴或不伴支架置入术(rePTA/S)。本研究旨在比较颈动脉内膜切除术联合支架取出术(CEASR)与 rePTA/S 治疗颈动脉 ISR 的安全性和有效性。

方法

连续纳入颈动脉 ISR(≥80%)患者,随机分配至 CEASR 或 rePTA/S 组。统计分析两组患者介入后再狭窄、卒中、短暂性脑缺血发作、心肌梗死和死亡的发生率,以及介入后 30 天和 1 年以及 CEASR 和 rePTA/S 组患者介入后 1 年的再狭窄率。

结果

共纳入 31 例患者,其中 14 例(9 例男性;平均年龄 66.3±6.6 岁)分配至 CEASR 组,17 例(10 例男性;平均年龄 68.8±5.6 岁)分配至 rePTA/S 组。CEASR 组所有患者均成功取出颈动脉再狭窄支架,两组患者均未发生围手术期、介入后 30 天和 1 年的临床血管事件。CEASR 组仅 1 例患者在 30 天内出现介入颈动脉无症状性闭塞,rePTA/S 组 1 例患者在介入后 1 年内死亡。rePTA/S 组介入后再狭窄率明显高于 CEASR 组(20.9%比 0%,p=0.04),但所有狭窄均<50%。rePTA/S 组和 CEASR 组 1 年再狭窄率≥70%的发生率无差异(4 例比 1 例;p=0.233)。

结论

CEASR 似乎是一种有效且安全的治疗颈动脉 ISR 的方法,可作为一种治疗选择。

试验注册号

NCT05390983。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3989/10648045/e474e65ace07/svn-2022-002075f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3989/10648045/8582917bac3e/svn-2022-002075f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3989/10648045/e474e65ace07/svn-2022-002075f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3989/10648045/8582917bac3e/svn-2022-002075f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3989/10648045/e474e65ace07/svn-2022-002075f02.jpg

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