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

Abstract

IntroductionTraditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of patch angioplasty to restore the arterial wall after longitudinal endarterectomy is, to date, not unequivocally proven to be superior to eversion technique. A systematic review is needed for evaluation of benefits and harms of the eversion technique versus the traditional endarterectomy with patch angioplasty in patients with symptomatic carotid stenosis.Methods and outcomesThe review will be conducted according to this protocol following the recommendations of the ‘Cochrane Handbook for Systematic Reviews’ and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomised clinical trials comparing eversion technique versus endarterectomy with patch angioplasty in patients with a symptomatic stenosis of the internal carotid artery will be included. Primary outcomes are all-cause mortality rate, health-related quality of life and serious adverse events. Secondary outcomes are 30-day stroke and mortality rate, symptomatic arterial restenosis or occlusion and non-serious adverse events. The databases Cochrane Central Register of Controlled Trials, PubMed/MEDLINE and EMBASE will be searched (November 2019). We will primarily base our conclusions on meta-analyses of trials with overall low-risk of bias. We will use trial sequential analysis to assist the evaluation of imprecision in Grading of Recommendations, Assessment, Development and Evaluation. 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 trial sequential analysis adjusted precision of the estimate achieved in all trials as the result of our meta-analyses.Ethics and disseminationThe proposed systematic review will collect and analyse data from published studies, therefore, ethical approval is not required. The results of the review will be disseminated by publication in a peer-review journal and submitted for presentation at conferences.PROSPERO registration numberCRD42019119361.

Does the eversion technique have a lower early postoperative stroke rate than the conventional technique in carotid endarterectomy?

“…The main advantage of the ECEA is that there is no need for a patch that minimizes the operative time and risk of postoperative infection. However, the difficulty of inserting the shunt before removing the plaque and the high rates of postoperative hypertension due to transecting the carotid sinus nerve branches and loss of baroreceptors limit its use [ 9 , 10 ].…”

Carotid endarterectomy; A new center, two years results

“…Studies showed that both eversion CEA and CCEA operations were safety methods with very rates low complication. Therefore, it is important that carotid surgery is performed by experienced surgeons with sufficient experience of the procedure, as emphasized in the guidelines (8,9).…”

Eversion technique versus traditional carotid endarterectomy with patch angioplasty: a systematic review with meta-analyses and trial sequential analysis

“…This review was conducted according to our published protocol [ 33 ] and was registered at PROSPERO ( https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019119361 ) [ 34 ], following the recommendations of the ‘Cochrane Handbook for Systematic Reviews of interventions’ [ 30 ] and is reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses ( PRISMA ) statement ( www.prisma-statement.org ) [ 35 ] and Assessing the methodological quality of systematic reviews (AMSTAR) guidelines [ 36 ]. According to the AMSTAR 2 Checklist, (enclosed as supplementary material) this review may be considered as a high-quality review.…”