Carotid endarterectomy with primary closure versus patch angioplasty in patients with symptomatic and significant stenosis: protocol for a systematic review with meta-analyses and trial sequential analysis of randomised clinical trials

Abstract

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.

Eversion technique versus conventional endarterectomy with patch angioplasty in carotid surgery: protocol for a systematic review with meta-analyses and trial sequential analysis of randomised clinical trials

“…Our previous published protocol39 may show overlap with this current protocol. This overlap is because of the basic methods to conduct a review process in line with the Cochrane Handbook 30.…”

“…Therefore, RCTs which compare primary closure of the arterial wall after longitudinal arteriotomy will be excluded. Other techniques for carotid surgery in symptomatic patients are investigated in separate reviews 38 39…”

Carotid endarterectomy with patch angioplasty versus primary closure in patients with symptomatic and significant stenosis: a systematic review with meta-analyses and trial sequential analysis of randomized clinical trials

“…This review was conducted according to the published protocol in BMJ Open [ 32 ] (see Supplementary file 4 ). The protocol was registered in PROSPERO in 2014, and this protocol was updated in October 2018 (CRD42014013416) following the recommendations of the “Cochrane Handbook for Systematic Reviews of Interventions” [ 30 ] and was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [ 35 ].…”

“…References of the identified trials were searched to identify any further relevant RCTs. We also searched online trial registries [ 32 ]. The search strategy is added as supplementary file 1 .…”

“…Therefore, an updated systematic review with meta-analyses is needed. To confirm or reject the meta-analysis results, we used trial sequential analysis (TSA) [ 32 ]. This review evaluates the current available evidence and assesses if this evidence is solid enough to base our current practice on it, while taking into consideration the changes in recent years (e.g., best medical treatment, use of ultrasound, centralization, and patch material).…”