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经颈动脉血运重建术与颈动脉内膜切除术治疗效果与安全性的系统评价及荟萃分析研究方案

Safety and efficacy of transcarotid artery revascularisation versus carotid endarterectomy: protocol for a systematic review and meta-analysis study.

机构信息

China International Neuroscience Institute (China-INI), Beijing, China.

Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.

出版信息

BMJ Open. 2021 May 4;11(5):e043039. doi: 10.1136/bmjopen-2020-043039.

Abstract

INTRODUCTION

In recent years, the transcarotid artery revascularisation (TCAR) with flow reversal technique has been developed to treat carotid artery stenosis. The superiority of TCAR over transfemoral carotid artery stenting has been demonstrated. However, the safety and efficacy of TCAR and carotid endarterectomy remain unclear. This study aims to introduce a protocol for a systematic review and meta-analysis to compare the morbidity and mortality rates between TCAR and carotid endarterectomy in the treatment of atherosclerotic carotid artery stenosis.

METHODS AND ANALYSIS

This protocol was drafted using the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement. Herein, major databases will be searched, including Medline, Web of Science, Embase and the Cochrane Library, and randomised controlled trials and high-quality observational studies will be included. We will screen all studies published from January 2000 to March 2021. Bias risk will be evaluated using the Cochrane Collaboration criteria or Methodological Index for Non-randomised Studies criteria, depending on the study type. Two reviewers will select eligible studies and extract the data independently. The primary outcome will include stroke or death during the perioperative period and follow-up. Subgroup and sensitivity analyses will be performed to explore any potential sources of heterogeneity. Specific results will be described in a narrative form when available eligible studies are insufficient for meta-analysis. Publication bias will be assessed using a funnel plot.

ETHICS AND DISSEMINATION

This study will summarise and analyse the existing literature; hence, ethics approval will not be required. The final results may be published at a relevant academic conference or in a journal.

PROSPERO REGISTRATION NUMBER

CRD42020178691.

摘要

简介

近年来,采用血流逆行技术的经颈动脉血管重建术(TCAR)已被开发用于治疗颈动脉狭窄。TCAR 优于经股动脉颈动脉支架置入术的优越性已得到证实。然而,TCAR 和颈动脉内膜切除术的安全性和有效性仍不清楚。本研究旨在介绍一项系统评价和荟萃分析的方案,以比较 TCAR 和颈动脉内膜切除术治疗动脉粥样硬化性颈动脉狭窄的发病率和死亡率。

方法和分析

本方案按照系统评价和荟萃分析报告的首选报告项目(PRISMA)声明起草。在此,将搜索主要数据库,包括 Medline、Web of Science、Embase 和 Cochrane 图书馆,并纳入随机对照试验和高质量观察性研究。我们将筛选 2000 年 1 月至 2021 年 3 月发表的所有研究。根据研究类型,使用 Cochrane 协作评价标准或非随机研究方法学指数评价标准评估偏倚风险。两名评审员将独立选择合格研究并提取数据。主要结局将包括围手术期和随访期间的卒中或死亡。将进行亚组和敏感性分析,以探索任何潜在的异质性来源。当可用的合格研究不足以进行荟萃分析时,将以叙述形式描述具体结果。使用漏斗图评估发表偏倚。

伦理和传播

本研究将总结和分析现有文献;因此,不需要伦理批准。最终结果可能在相关学术会议或期刊上发表。

PROSPERO 注册号:CRD42020178691。

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