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有症状颈动脉狭窄的颈动脉内膜切除术

Carotid endarterectomy for symptomatic carotid stenosis.

作者信息

Rerkasem Amaraporn, Orrapin Saritphat, Howard Dominic Pj, Rerkasem Kittipan

机构信息

Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.

Division of Vascular Surgery, Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), Pathum thani, Thailand.

出版信息

Cochrane Database Syst Rev. 2020 Sep 12;9(9):CD001081. doi: 10.1002/14651858.CD001081.pub4.

Abstract

BACKGROUND

Stroke is the third leading cause of death and the most common cause of long-term disability. Severe narrowing (stenosis) of the carotid artery is an important cause of stroke. Surgical treatment (carotid endarterectomy) may reduce the risk of stroke, but carries a risk of operative complications. This is an update of a Cochrane Review, originally published in 1999, and most recently updated in 2017.

OBJECTIVES

To determine the balance of benefit versus risk of endarterectomy plus best medical management compared with best medical management alone, in people with a recent symptomatic carotid stenosis (i.e. transient ischaemic attack (TIA) or non-disabling stroke).

SEARCH METHODS

We searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, Web of Science Core Collection, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) portal to October 2019. We also reviewed the reference lists of all relevant studies and abstract books from research proceedings.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) comparing carotid artery surgery plus best medical treatment with best medical treatment alone.  DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted the data. We assessed the results and the quality of the evidence of the primary and secondary outcomes by the GRADE method, which classifies the quality of evidence as high, moderate, low, or very low.

MAIN RESULTS

We included three trials involving 6343 participants. The trials differed in the methods of measuring carotid stenosis and in the definition of stroke. Using the primary electronic data files, we pooled and analysed individual patient data on 6092 participants (35,000 patient-years of follow-up), after reassessing the carotid angiograms and outcomes from all three trials, and redefining outcome events where necessary, to achieve comparability. Surgery increased the five-year risk of any stroke or operative death in participants with less than 30% stenosis (risk ratio (RR) 1.25, 95% confidence interval (CI) 0.99 to 1.56; 2 studies, 1746 participants; high-quality evidence). Surgery decreased the five-year risk of any stroke or operative death in participants with 30% to 49% stenosis (RR 0.97, 95% CI 0.79 to 1.19; 2 studies, 1429 participants; high-quality evidence), was of benefit in participants with 50% to 69% stenosis (RR 0.77, 95% CI 0.63 to 0.94; 3 studies, 1549 participants; moderate-quality evidence), and was highly beneficial in participants with 70% to 99% stenosis without near-occlusion (RR 0.53, 95% CI 0.42 to 0.67; 3 studies, 1095 participants; moderate-quality evidence). However, surgery decreased the five-year risk of any stroke or operative death in participants with near-occlusions (RR 0.95, 95% CI 0.59 to 1.53; 2 studies, 271 participants; moderate-quality evidence).

AUTHORS' CONCLUSIONS: Carotid endarterectomy reduced the risk of recurrent stroke for people with significant stenosis. Endarterectomy might be of some benefit for participants with 50% to 69% symptomatic stenosis (moderate-quality evidence) and highly beneficial for those with 70% to 99% stenosis (moderate-quality evidence).

摘要

背景

中风是第三大致死原因,也是长期残疾的最常见原因。颈动脉严重狭窄是中风的一个重要原因。手术治疗(颈动脉内膜切除术)可能会降低中风风险,但存在手术并发症风险。这是Cochrane系统评价的更新版,最初发表于1999年,最近一次更新是在2017年。

目的

确定在近期有症状性颈动脉狭窄(即短暂性脑缺血发作(TIA)或非致残性中风)的患者中,与单纯最佳药物治疗相比,内膜切除术加最佳药物治疗的利弊平衡。

检索方法

我们检索了Cochrane中风组试验注册库、CENTRAL、MEDLINE Ovid、Embase Ovid、Web of Science核心合集、ClinicalTrials.gov以及世界卫生组织国际临床试验注册平台(ICTRP)门户,检索截至2019年10月。我们还查阅了所有相关研究的参考文献列表以及研究会议的摘要书籍。

入选标准

我们纳入了比较颈动脉手术加最佳药物治疗与单纯最佳药物治疗的随机对照试验(RCT)。

数据收集与分析

两位综述作者独立选择研究、评估偏倚风险并提取数据。我们采用GRADE方法评估主要和次要结局的结果及证据质量,该方法将证据质量分为高、中、低或极低。

主要结果

我们纳入了3项试验,涉及6343名参与者。这些试验在测量颈动脉狭窄的方法和中风的定义上存在差异。使用原始电子数据文件,在重新评估所有三项试验的颈动脉血管造影和结局,并在必要时重新定义结局事件以实现可比性后,我们汇总并分析了6092名参与者(35000人年的随访)的个体患者数据。手术增加了狭窄程度小于30%的参与者发生任何中风或手术死亡的五年风险(风险比(RR)1.25,95%置信区间(CI)0.99至1.56;2项研究,1746名参与者;高质量证据)。手术降低了狭窄程度为30%至49%的参与者发生任何中风或手术死亡的五年风险(RR 0.97,95%CI 0.79至1.19;2项研究,1429名参与者;高质量证据),对狭窄程度为50%至69%的参与者有益(RR 0.77,95%CI 0.63至0.94;3项研究,1549名参与者;中等质量证据),对狭窄程度为70%至99%且无近乎闭塞的参与者非常有益(RR 0.53,95%CI 0.42至0.67;3项研究,1095名参与者;中等质量证据)。然而,手术降低了近乎闭塞的参与者发生任何中风或手术死亡的五年风险(RR 0.95,95%CI 0.59至1.53;2项研究,271名参与者;中等质量证据)。

作者结论

颈动脉内膜切除术降低了严重狭窄患者复发性中风的风险。内膜切除术可能对有50%至69%症状性狭窄的参与者有一定益处(中等质量证据),对有70%至99%狭窄的参与者非常有益(中等质量证据)。

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