Dataset Information

Risk factors for new ischaemic cerebral lesions after carotid artery stenting: protocol for a systematic review and meta-analysis.

ABSTRACT:

Introduction

New ischaemic cerebral lesions (NICL) detected by diffusion-weighted imaging MRI are common after carotid artery stenting (CAS), with an occurrence rate ranging from 18% to 57%. Many studies reported occurrence of NICL could increase risk of future cerebrovascular events and cognitive impairment. However, controversies about determinants for occurrence of NICL after CAS exist among studies, and one risk factor embodied in an article may not be in another. Aim of this study is to introduce a protocol for a systematic review and meta-analysis to identify risk factors associated with occurrence of NICL after CAS.

Methods and analysis

All relevant literature referring to risk factors for occurrence of NICL after CAS will be searched on the major databases, such as PubMed, Embase, Web of Science and the Cochrane Library until 31 December 2018. Literature, which must be randomised controlled trials, case-control studies or cohort studies, will be included in accordance with the prespecified eligibility criteria. The risk of bias will be assessed using the Cochrane Collaboration criteria and the quality of evidence will be assessed with the corresponding scale. Data will be extracted with a form prepared before and analysed using RevMan V.5.3 analyses software. Heterogeneity will be assessed using I² statistic. Our systematic review will be performed according to the guidance from the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.

Ethics and dissemination

There is no need for ethical approval because primary data will not be attained. The systematic review will be presented at international conferences and published in peer-reviewed journals.

Prospero registration number

CRD42019121129.

SUBMITTER: Feng Y

PROVIDER: S-EPMC6719763 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

Risk factors for new ischaemic cerebral lesions after carotid artery stenting: protocol for a systematic review and meta-analysis.

Feng Yao Y Li Long L Bai Xuesong X Wang Tao T Chen Yanfei Y Zhang Xiao X Ling Feng F Jiao Liqun L

BMJ open 20190824 8

<h4>Introduction</h4>New ischaemic cerebral lesions (NICL) detected by diffusion-weighted imaging MRI are common after carotid artery stenting (CAS), with an occurrence rate ranging from 18% to 57%. Many studies reported occurrence of NICL could increase risk of future cerebrovascular events and cognitive impairment. However, controversies about determinants for occurrence of NICL after CAS exist among studies, and one risk factor embodied in an article may not be in another. Aim of this study i ...[more]

PMID: 31446417

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Project description:BackgroundBrain lesions on diffusion-weighted imaging (DWI) are frequently found after carotid artery stenting (CAS), but their clinical relevance remains unclear.ObjectivesThis study sought to investigate whether periprocedural ischemic DWI lesions after CAS or carotid endarterectomy (CEA) are associated with an increased risk of recurrent cerebrovascular events.MethodsIn the magnetic resonance imaging (MRI) substudy of ICSS (International Carotid Stenting Study), 231 patients with symptomatic carotid stenosis were randomized to undergo CAS (n=124) or CEA (n=107). MRIs were performed 1 to 7 days before and 1 to 3 days after treatment. The primary outcome event was stroke or transient ischemic attack in any territory occurring between the post-treatment MRI and the end of follow-up. Time to occurrence of the primary outcome event was compared between patients with (DWI+) and without (DWI-) new DWI lesions on the post-treatment scan in the CAS and CEA groups separately.ResultsMedian time of follow-up was 4.1 years (interquartile range: 3.0 to 5.2). In the CAS group, recurrent stroke or transient ischemic attack occurred more often among DWI+ patients (12 of 62) than among DWI- patients (6 of 62), with a cumulative 5-year incidence of 22.8% (standard error [SE]: 7.1%) and 8.8% (SE: 3.8%), respectively (unadjusted hazard ratio: 2.85; 95% confidence interval: 1.05 to 7.72; p=0.04). In DWI+ and DWI- patients, 8 and 2 events, respectively, occurred within 6 months after treatment. In the CEA group, there was no difference in recurrent cerebrovascular events between DWI+ and DWI- patients.ConclusionsIschemic brain lesions discovered on DWI after CAS seem to be a marker of increased risk for recurrent cerebrovascular events. Patients with periprocedural DWI lesions might benefit from more aggressive and prolonged antiplatelet therapy after CAS. (A Randomised Comparison of the Risks, Benefits and Cost Effectiveness of Primary Carotid Stenting With Carotid Endarterectomy: International Carotid Stenting Study; ISRCTN25337470).

Project description:BackgroundCarotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered the first-line treatment for carotid stenosis worldwide, and the safety and efficacy of CAS compared to CEA remains in question.ObjectiveThe purpose of this study is to compare the practice and outcomes of CAS and CEA in a real-world setting within public university hospitals in Brazil.MethodsThis study will be a prospective 5-year analysis of treatment for atherosclerotic carotid stenosis with CEA and CAS performed at 5 centers affiliated with the Vascular Study Group at public university hospitals in Brazil. The indications for the procedures will be determined by each surgeon's individual discretion, in accordance with preoperative risk evaluation. The primary outcome measures will be (1) any in-hospital stroke or death, and (2) any per-procedural stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery will be excluded from the study. Multivariate logistic regression will be performed to identify predictors of stroke or death in patients undergoing CEA and CAS. All tests of significance will be performed at the .05 level. This study was approved by the Committee of Ethics in Research at the University Hospital of Ribeirao Preto Medical School, and in all other participating institutions linked to National Research System and National Board of Health in Brazil (Process 15695/2011).ResultsThis study is currently in the recruitment phase, and the final patient is expected to be enrolled by the end of 2018. We hope to recruit approximately 800 patients to the study. Analyses will focus on primary end points for patients that are allocated to each treatment group. During the per-procedural period, the occurrence of the primary end point components (stroke, MI, or death) for CAS and CEA will be analyzed for symptomatic or asymptomatic subjects.ConclusionsThe analyses of the primary endpoints (and all others variables of the study) are expected to be published in 2019 in a peer reviewed journal, and results will be presented at scientific meetings, with summary results published online. This study will obtain new data related to the quality of treatment for carotid disease in Brazil at the primary training centers of future vascular surgeons, but the initial data that will be obtained and published (with the outcomes and complications) are restricted to the first 30 days postprocedure. This time restriction limits the comparison of the results that relate to the main goal of treatment, which is to decrease the risk of stroke over 5 years. The purpose of the study group is to continue the monitoring of patient records, and evaluate the follow-up data in the 5 years following the initial evaluation. This study protocol will contribute very significantly to improving the care of patients with carotid disease, in addition to qualifying the level of assistance provided in public university hospitals in the state of São Paulo, Brazil.Trial registrationClinicaltrials.gov NCT02538276; https://www.clinicaltrials.gov/ct2/show/NCT02538276 (Archived by WebCite at http://www.webcitation.org/6m7APnFLD).

Dataset Information

Risk factors for new ischaemic cerebral lesions after carotid artery stenting: protocol for a systematic review and meta-analysis.

Introduction

Methods and analysis

Ethics and dissemination

Prospero registration number

Publications

Risk factors for new ischaemic cerebral lesions after carotid artery stenting: protocol for a systematic review and meta-analysis.

Similar Datasets

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