Dataset Information

Benefit of carotid revascularisation for women with symptomatic carotid stenosis: protocol for a systematic review.

ABSTRACT: INTRODUCTION:Carotid intervention in the form of endarterectomy or stenting is the current standard of care for the majority of patients with symptomatic high-grade carotid stenosis. However, some randomised controlled trials (RCT) have demonstrated that women benefited significantly less from intervention than men. It is unclear if this is a true phenomenon or a study sampling artefact, as women were severely under-represented in all RCTs of carotid revascularisation. A systematic review is needed to summarise the existing data and to answer the question of whether a women-only trial for symptomatic patients with ipsilateral carotid stenosis is scientifically necessary and ethically permissible. METHODS AND ANALYSIS:We will systematically search Medline, Embase, PubMed and the Cochrane libraries for all studies with data from RCTs that included women and compared either endarterectomy with stenting or revascularisation (by means of endarterectomy or stenting) with medical therapy in patients with symptomatic carotid stenosis. Search dates will be restricted to 1991-2018. Two reviewers will conduct screening search results, study selection, data extraction and quality assessment. We will include all studies reporting outcomes of interest. Planned subgroup analysis based on revascularisation technique, degree of stenosis and timing of intervention from the index event will be conducted with enough data. ETHICS AND DISSEMINATION:This research is exempt of ethics approval as no primary data will be collected. The results will be published in peer-reviewed journals and disseminated through national and international-level conferences and scientific meetings. The result of this comprehensive review will provide useful information on whether further RCTs are required to study a women-only population with symptomatic carotid disease. PROSPERO REGISTRATION NUMBER:CRD42019134967.

SUBMITTER: Bereznyakova O

PROVIDER: S-EPMC6858193 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Benefit of carotid revascularisation for women with symptomatic carotid stenosis: protocol for a systematic review.

Bereznyakova Olena O Dewar Brian B Dowlatshahi Dar D Howard Virginia V Hamel Candyce C Gocan Sophia S Fedyk Mark M Shamy Michel M

BMJ open 20191111 11

<h4>Introduction</h4>Carotid intervention in the form of endarterectomy or stenting is the current standard of care for the majority of patients with symptomatic high-grade carotid stenosis. However, some randomised controlled trials (RCT) have demonstrated that women benefited significantly less from intervention than men. It is unclear if this is a true phenomenon or a study sampling artefact, as women were severely under-represented in all RCTs of carotid revascularisation. A systematic revie ...[more]

PMID: 31719088

Similar Datasets

Project description:IntroductionPrediction models for clinical outcome after carotid artery stenting or carotid endarterectomy could aid physicians in estimating peri- and postprocedural risks in individual patients. We aimed to identify existing prediction models for short- and long-term outcome after carotid artery stenting or carotid endarterectomy in patients with symptomatic or asymptomatic carotid stenosis, and to summarise their most important predictors and predictive performance.Patients and methodsWe performed a systematic literature search for studies that developed a prediction model or risk score published until 22 December 2016. Eligible prediction models had to predict the risk of vascular events with at least one patient characteristic.ResultsWe identified 37 studies that developed 46 prediction models. Thirty-four (74%) models were developed in carotid endarterectomy patients; 27 of these (59%) predicted short-term (in-hospital or within 30 days) risk. Most commonly predicted outcome was stroke or death (n = 12; 26%). Age (n = 31; 67%), diabetes mellitus (n = 21; 46%), heart failure (n = 16; 35%), and contralateral carotid stenosis ≥50% or occlusion (n = 16; 35%) were most commonly used as predictors. For 25 models (54%), it was unclear how missing data were handled; a complete case analysis was performed in 15 (33%) of the remaining 21 models. Twenty-eight (61%) models reported the full regression formula or risk score with risk classification. Twenty-one (46%) models were validated internally and 12 (26%) externally. Discriminative performance (c-statistic) ranged from 0.66 to 0.94 for models after carotid artery stenting and from 0.58 to 0.74 for models after carotid endarterectomy. The c-statistic ranged from 0.55 to 0.72 for the external validations.DiscussionAge, diabetes mellitus, heart failure, and contralateral carotid stenosis ≥50% or occlusion were most often used as predictors in all models. Discriminative performance (c-statistic) was higher for prediction models after carotid artery stenting than after carotid endarterectomy.ConclusionThe clinical usefulness of most prediction models for short- or long-term outcome after carotid artery stenting or carotid endarterectomy remains unclear because of incomplete reporting, methodological limitations, and lack of external validation.

Project description:IntroductionAtherosclerotic intracranial artery stenosis (ICAS) is one of most common causes of stroke, which is the second-leading cause of death worldwide. Medical, surgical and endovascular therapy are three major treatments for ICAS. Currently, medical therapy is considered as the standard of care for most patients with ICAS, while extracranial to intracranial bypass is only used in rare situations. Balloon angioplasty alone, balloon-mounted stent and self-expanding stent, collectively called endovascular treatment, have shown promising potentials in treating specific subgroups of patients with symptomatic ICAS; however, their comparative safety and efficacy is still unclear. Therefore, a systematic review with network meta-analysis is needed to establish a hierarchy of these endovascular treatments.Methods and analysisThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols was followed to establish this protocol. The search will be limited to studies published from 1 January 2000 to the formal search date. Major databases including Cochrane Library, MEDLINE, EMBASE, Chinese Biomedical Literature Database, conference proceedings and grey literature database will be searched for clinical studies comparing at least two interventions for patients with symptomatic ICAS. Primary outcomes include short-term and long-term mortality or stroke rate. Random effects pairwise and network meta-analyses of included studies will be performed on STATA (V.14, StataCorp, 2015). The surface under the cumulative ranking curve and mean rank will be calculated in order to establish a hierarchy of the endovascular treatments. Evaluation of the risk of bias, heterogeneity, consistency, transitivity and quality of evidence will follow the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions.Ethics and disseminationEthics approval is not needed as systematic review is based on published studies. Study findings will be presented at international conferences and published on a peer-reviewed journal.Prospero registration numberCRD42018084055; Pre-results.

Project description:BackgroundCarotid endarterectomy is currently recommended for patients with recently symptomatic carotid stenosis ≥50%, based on randomised trials conducted 30 years ago. Several factors such as carotid plaque ulceration, age and associated comorbidities might influence the risk-benefit ratio of carotid revascularisation. A model developed in previous trials that calculates the future risk of stroke based on these features can be used to stratify patients into low, intermediate or high risk. Since the original trials, medical treatment has improved significantly. Our hypothesis is that patients with carotid stenosis ≥50% associated with a low to intermediate risk of stroke will not benefit from additional carotid revascularisation when treated with optimised medical therapy. We also hypothesise that prediction of future risk of stroke in individual patients with carotid stenosis can be improved using the results of magnetic resonance imaging (MRI) of the carotid plaque.MethodsPatients are randomised between immediate revascularisation plus OMT versus OMT alone. Suitable patients are those with asymptomatic or symptomatic carotid stenosis ≥50% with an estimated 5-year risk of stroke of <20%, as calculated using the Carotid Artery Risk score. MRI of the brain at baseline and during follow-up will be used as a blinded measure to assess the incidence of silent infarction and haemorrhage, while carotid plaque MRI at baseline will be used to investigate the hypotheses that plaque characteristics determine future stroke risk and help identify a subgroup of patients that will benefit from revascularisation. An initial analysis will be conducted after recruitment of 320 patients with baseline MRI and a minimum of 2 years of follow-up, to provide data to inform the design and sample size for a continuation or re-launch of the study. The primary outcome measure of this initial analysis is the combined 2-year rate of any clinically manifest stroke, new cerebral infarct on MRI, myocardial infarction or periprocedural death.DiscussionECST-2 will provide new data on the efficacy of modern optimal medical therapy alone versus added carotid revascularisation in patients with carotid stenosis at low to intermediate risk of future stroke selected by individualised risk assessment. We anticipate that the results of baseline brain and carotid plaque MRI will provide data to improve the prediction of the risk of stroke and the effect of treatment in patients with carotid stenosis.Trial registrationISRCTN registry ISRCTN97744893 . Registered on 05 July 2012.

Project description:IntroductionUse of patch angioplasty in carotid endarterectomy (CEA) is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke. The objective is to conduct a systematic review with meta-analysis and trial sequential analysis as well as Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments comparing the benefits and harms of CEA with primary closure of the arterial wall versus CEA with patch angioplasty in patients with a symptomatic and significant carotid stenosis.Methods and analysisThe review shall be conducted according to this published protocol following the recommendations of the 'Cochrane' and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Randomised clinical trials comparing CEA with primary closure of the arterial wall versus CEA with patch angioplasty (regardless of used patch materials) in human adults with a symptomatic and significant carotid stenosis will be included. Primary outcomes are all-cause mortality at maximal follow-up, health-related quality of life and serious adverse events. Secondary outcomes are symptomatic or asymptomatic arterial occlusion or restenosis, and non-serious adverse events. We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the precision achieved in all trials as the result of our meta-analyses.Ethics and disseminationThe proposed systematic review will collect and analyse secondary data from published studies therefor ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences.Prospero registration numberCRD42014013416.

Dataset Information

Benefit of carotid revascularisation for women with symptomatic carotid stenosis: protocol for a systematic review.

Publications

Benefit of carotid revascularisation for women with symptomatic carotid stenosis: protocol for a systematic review.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets