Treatment strategies for asymptomatic carotid artery stenosis in the era of lipid-lowering drugs: protocol for a systematic review and network meta-analysis

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Abstract

Introduction

Carotid endarterectomy (CEA), carotid artery stenting (CAS) and best medical therapy (BMT) are the major treatments used for significant asymptomatic carotid artery stenosis (ACAS, ≥50%). However, the widespread use of lipid-lowering drugs in this century has improved BMT outcomes. This study aims to compare the treatment efficacy of current BMT, CEA+BMT and CAS+BMT in patients with significant ACAS.

Methods and analysis

This protocol was designed based on the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Publication time for studies will be set from 1 January 2000 to 1 June 2020. We will search three databases: PubMed, EMBASE and The Cochrane Library. Suitable randomised controlled studies will be screened. The primary outcomes will include short-term and long-term mortality, stroke and myocardial infarction. OR and HR for dichotomous data and time-to-event data with 95% CIs will be calculated. Treatment effects among different therapies will be ranked according to the surface under the cumulative ranking curve and mean rank. A comprehensive evaluation of the risk of bias, heterogeneity and transitivity will be performed before data synthesis. Consistency and evidence quality will also be assessed.

Ethics and dissemination

There will be no need for ethics approval as this systematic review is a summary and analysis of existing literature. Final results may be presented in international conferences or a peer-reviewed journal.

PROSPERO registration number

CRD42019138942.

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Most cited references 42

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Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study.

JF Toole, M Goldstein, JR Marler … (1995)

To determine whether the addition of carotid endarterectomy to aggressive medical management can reduce the incidence of cerebral infarction in patients with asymptomatic carotid artery stenosis. Prospective, randomized, multicenter trial. Thirty-nine clinical sites across the United States and Canada. Between December 1987 and December 1993, a total of 1662 patients with asymptomatic carotid artery stenosis of 60% or greater reduction in diameter were randomized; follow-up data are available on 1659. At baseline, recognized risk factors for stroke were similar between the two treatment groups. Daily aspirin administration and medical risk factor management for all patients; carotid endarterectomy for patients randomized to receive surgery. Initially, transient ischemic attack or cerebral infarction occurring in the distribution of the study artery and any transient ischemic attack, stroke, or death occurring in the perioperative period. In March 1993, the primary outcome measures were changed to cerebral infarction occurring in the distribution of the study artery or any stroke or death occurring in the perioperative period. After a median follow-up of 2.7 years, with 4657 patient-years of observation, the aggregate risk over 5 years for ipsilateral stroke and any perioperative stroke or death was estimated to be 5.1% for surgical patients and 11.0% for patients treated medically (aggregate risk reduction of 53% [95% confidence interval, 22% to 72%]). Patients with asymptomatic carotid artery stenosis of 60% or greater reduction in diameter and whose general health makes them good candidates for elective surgery will have a reduced 5-year risk of ipsilateral stroke if carotid endarterectomy performed with less than 3% perioperative morbidity and mortality is added to aggressive management of modifiable risk factors.

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Evaluation of inconsistency in networks of interventions.

Areti Angeliki Veroniki, Haris Vasiliadis, Julian P.T. Higgins … (2013)

The assumption of consistency, defined as agreement between direct and indirect sources of evidence, underlies the increasingly popular method of network meta-analysis. No evidence exists so far regarding the extent of inconsistency in full networks of interventions or the factors that control its statistical detection. In this paper we assess the prevalence of inconsistency from data of 40 published networks of interventions involving 303 loops of evidence. Inconsistency is evaluated in each loop by contrasting direct and indirect estimates and by employing an omnibus test of consistency for the entire network. We explore whether different effect measures for dichotomous outcomes are associated with differences in inconsistency, and evaluate whether different ways to estimate heterogeneity affect the magnitude and detection of inconsistency. Inconsistency was detected in from 2% to 9% of the tested loops, depending on the effect measure and heterogeneity estimation method. Loops that included comparisons informed by a single study were more likely to show inconsistency. About one-eighth of the networks were found to be inconsistent. The proportions of inconsistent loops do not materially change when different effect measures are used. Important heterogeneity or the overestimation of heterogeneity was associated with a small decrease in the prevalence of statistical inconsistency. The study suggests that changing the effect measure might improve statistical consistency, and that an analysis of sensitivity to the assumptions and an estimator of heterogeneity might be needed before reaching a conclusion about the absence of statistical inconsistency, particularly in networks with few studies.

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Is network meta-analysis as valid as standard pairwise meta-analysis? It all depends on the distribution of effect modifiers

Jeroen P Jansen, Huseyin Naci (2013)

Background In the last decade, network meta-analysis of randomized controlled trials has been introduced as an extension of pairwise meta-analysis. The advantage of network meta-analysis over standard pairwise meta-analysis is that it facilitates indirect comparisons of multiple interventions that have not been studied in a head-to-head fashion. Although assumptions underlying pairwise meta-analyses are well understood, those concerning network meta-analyses are perceived to be more complex and prone to misinterpretation. Discussion In this paper, we aim to provide a basic explanation when network meta-analysis is as valid as pairwise meta-analysis. We focus on the primary role of effect modifiers, which are study and patient characteristics associated with treatment effects. Because network meta-analysis includes different trials comparing different interventions, the distribution of effect modifiers cannot only vary across studies for a particular comparison (as with standard pairwise meta-analysis, causing heterogeneity), but also between comparisons (causing inconsistency). If there is an imbalance in the distribution of effect modifiers between different types of direct comparisons, the related indirect comparisons will be biased. If it can be assumed that this is not the case, network meta-analysis is as valid as pairwise meta-analysis. Summary The validity of network meta-analysis is based on the underlying assumption that there is no imbalance in the distribution of effect modifiers across the different types of direct treatment comparisons, regardless of the structure of the evidence network.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2020

Publication date (Electronic): 5 July 2020

Volume: 10

Issue: 7

Electronic Location Identifier: e035094

Affiliations

[1 ]departmentDepartment of Neurosurgery , Xuanwu Hospital, Capital Medical University , Beijing, China

[2 ]departmentDepartment of Evidence-based Medicine , Xuanwu Hospital , Beijing, China

[3 ]departmentMedical Library , Xuanwu Hospital, Capital Medical University , Beijing, China

Author notes

[Correspondence to ] Dr Liqun Jiao; liqunjiao@ 123456126.com

Author information

Yao Feng http://orcid.org/0000-0001-7923-8158

Tao Wang http://orcid.org/0000-0003-1225-0173

Jichang Luo http://orcid.org/0000-0002-8341-0966

Article

Publisher ID: bmjopen-2019-035094

DOI: 10.1136/bmjopen-2019-035094

PMC ID: 7337893

PubMed ID: 32624471

SO-VID: 16b3a5b3-1c5b-4f48-be7d-00b5c0dbca7b

License:

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 18 October 2019

Date revision received : 21 December 2019

Date accepted : 30 December 2019

Funding

Funded by: the Beijing Scientific and Technologic Project;

Award ID: D161100003816002

Funded by: the National Key Research and Development Project;

Award ID: 2016YFC1301703

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ScienceOpen disciplines: Medicine

Keywords: stroke medicine,stroke,neurosurgery

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ScienceOpen disciplines: Medicine

Keywords: stroke medicine, stroke, neurosurgery

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Treatment strategies for asymptomatic carotid artery stenosis in the era of lipid-lowering drugs: protocol for a systematic review and network meta-analysis

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

PROSPERO registration number

Related collections

Stroke MRI

Most cited references 42

Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study.

Evaluation of inconsistency in networks of interventions.

Is network meta-analysis as valid as standard pairwise meta-analysis? It all depends on the distribution of effect modifiers

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Author notes

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Cited by 5

Most referenced authors 977