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无症状、非 80 岁以上、标准风险的颈动脉狭窄患者支架置入术与颈动脉内膜切除术治疗的临床试验。

Treatment of carotid stenosis in asymptomatic, nonoctogenarian, standard risk patients with stenting versus endarterectomy trials.

机构信息

Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisc.

Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisc.

出版信息

J Vasc Surg. 2022 Apr;75(4):1276-1283.e1. doi: 10.1016/j.jvs.2021.10.020. Epub 2021 Oct 22.

DOI:10.1016/j.jvs.2021.10.020
PMID:34695552
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9365439/
Abstract

OBJECTIVE

Asymptomatic carotid stenosis is the most frequent indication for carotid endarterectomy (CEA) in the United States. Published trials and guidelines support CEA indications in selected patients with longer projected survival and when periprocedural complications are low. Transfemoral carotid artery stenting with embolic protection (CAS) is a newer treatment option. The objective of this study was to compare outcomes in asymptomatic, nonoctogenarian patients treated with CAS vs CEA.

METHODS

Patient-level data was analyzed from 2544 subjects with ≥70% asymptomatic carotid stenosis who were randomized to CAS or CEA in addition to standard medical therapy. One trial enrolled 1091 (548 CAS, 543 CEA) and another enrolled 1453 (1089 CAS, 364 CEA) asymptomatic patients less than 80 years old (upper age eligibility). Independent neurologic assessment and routine cardiac enzyme screening were performed. The prespecified, primary composite endpoint was any stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke within 4 years after randomization.

RESULTS

There was no significant difference in the primary endpoint between CAS and CEA (5.3% vs 5.1%; hazard ratio, 1.02; 95% confidence interval, 0.7-1.5; P = .91). Periprocedural rates for the components are (CAS vs CEA): any stroke (2.7% vs 1.5%; P = .07), myocardial infarction (0.6% vs 1.7%; P = .01), death (0.1% vs 0.2%; P = .62), and any stroke or death (2.7% vs 1.6%; P = .07). After this period, the rates of ipsilateral stroke were similar (2.3% vs 2.2%; P = .97).

CONCLUSIONS

In a pooled analysis of two large randomized trials of CAS and CEA in asymptomatic, nonoctogenarian patients, CAS achieves comparable short- and long-term results to CEA.

摘要

目的

无症状颈动脉狭窄是美国颈动脉内膜切除术(CEA)最常见的适应证。已发表的临床试验和指南支持在预期寿命较长且围手术期并发症较低的情况下,选择特定患者进行 CEA 治疗。带栓子保护装置的经股动脉颈动脉支架置入术(CAS)是一种新的治疗选择。本研究旨在比较无症状、非 80 岁以下患者接受 CAS 与 CEA 治疗的结果。

方法

对 2544 例无症状颈动脉狭窄≥70%的患者进行了患者水平数据分析,这些患者在标准药物治疗的基础上被随机分配至 CAS 或 CEA 组。一项试验纳入了 1091 例(548 例 CAS,543 例 CEA)无症状、年龄小于 80 岁(年龄上限符合条件)的患者,另一项试验纳入了 1453 例(1089 例 CAS,364 例 CEA)无症状、年龄小于 80 岁的患者。进行了独立的神经学评估和常规心脏酶学筛查。预先设定的主要复合终点是围手术期或随机分组后 4 年内同侧卒中发生的任何卒中和/或心肌梗死和死亡。

结果

CAS 与 CEA 之间主要终点无显著差异(5.3% vs. 5.1%;风险比,1.02;95%置信区间,0.7-1.5;P=.91)。各组成部分的围手术期发生率为:任何卒中和(2.7% vs. 1.5%;P=.07)、心肌梗死(0.6% vs. 1.7%;P=.01)、死亡(0.1% vs. 0.2%;P=.62)以及任何卒中和死亡(2.7% vs. 1.6%;P=.07)。在此期间,同侧卒中发生率相似(2.3% vs. 2.2%;P=.97)。

结论

在对无症状、非 80 岁以下患者的 CAS 和 CEA 进行的两项大型随机试验的汇总分析中,CAS 与 CEA 相比可取得相似的短期和长期结果。

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