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

Abstract

Background: Patch angioplasty in conventional carotid endarterectomy is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke compared with primary closure. A systematic review of randomized clinical trials is needed to compare outcomes (benefits and harms) of both techniques.

Methods: Searches (CENTRAL, PubMed/MEDLINE, EMBASE, and other databases) were last updated 3rd of January 2021. We included randomized clinical trials comparing carotid endarterectomy with patch angioplasty versus primary closure of the arterial wall in patients with a symptomatic and significant (> 50%) carotid stenosis. Primary outcomes are defined as all-cause mortality and serious adverse events.

Results: We included 12 randomized clinical trials including 2187 participants who underwent 2335 operations for carotid stenosis comparing carotid endarterectomy with patch closure (1280 operations) versus carotid endarterectomy with primary closure (1055 operations). Meta-analysis comparing carotid endarterectomy with patch angioplasty versus carotid endarterectomy with primary closure may potentially decrease the number of patients with all-cause mortality (RR 0.53; 95% CI 0.26 to 1.08; p = 0.08, best-case scenario for patch), serious adverse events (RR 0.73; 95% CI 0.56 to 0.96; p = 0.02, best-case scenario for patch), and the number of restenosis (RR 0.41; 95% CI 0.23 to 0.71; p < 0.01). Trial sequential analysis demonstrated that the required information sizes were far from being reached for these patient-important outcomes. All the patient-relevant outcomes were at low certainty of evidence according to The Grading of Recommendations Assessment, Development, and Evaluation.

Conclusions: This systematic review showed no conclusive evidence of a difference between carotid endarterectomy with patch angioplasty versus primary closure of the arterial wall on all-cause mortality, < 30 days mortality, < 30 days stroke, or any other serious adverse events. These conclusions are based on data from 15 to 35 years ago, obtained in trials with very low certainty according to GRADE, and should be interpreted cautiously. Therefore, we suggest conducting new randomized clinical trials patch angioplasty versus primary closure in carotid endarterectomy in symptomatic patients with an internal carotid artery stenosis of 50% or more. Such trials ought to be designed according to the Standard Protocol Items: Recommendations for Interventional Trials statement (Chan et al., Ann Intern Med 1:200-7, 2013) and reported according to the Consolidated Standards of Reporting Trials statement (Schulz et al., 7, 2010). Until conclusive evidence is obtained, the standard of care according to guidelines should not be abandoned.

Systematic review registration: PROSPERO CRD42014013416 . Review protocol publication 2019 DOI: https://doi.org/10.1136/bmjopen-2018-026419 .

Keywords: Carotid endarterectomy; Carotid stenosis; GRADE; Patch; Primary closure; Systematic review; Trial sequential analysis.

Fig. 1

Closure of carotid artery. CCA: common carotid artery, STA: superior thyroid artery, ECA: external carotid artery, ICA: internal carotid artery. a Longitudinal arteriotomy. b Primary closure of longitudinal arteriotomy. c Closure of longitudinal arteriotomy with patch angioplasty

Fig. 2

Hierarchy of outcomes from patients’ perspective undergoing carotid endarterectomy for symptomatic carotid stenosis (GRADE 2008). *At maximum follow-up. Serious adverse events such as neck hematoma and cranial nerve injury. Other serious adverse events include stroke < 30 days

Fig. 3

Flow diagram summarizing the search process and results of each phase of the systematic review. doi:10.1371/journal.pmed1000097

Fig. 4

Risk of bias summary of all included trials, the eight criteria on the X-axis. Name of first author and year of trial on Y-axis. + = adequate. − = inadequate. question mark (?) = unclear

Fig. 5

Forest plot on all-cause mortality (random-effect model). a Best-case scenario patch angioplasty. b Worst-case scenario patch angioplasty

Fig. 6

Forest plot on < 30 days (procedure related) mortality (random-effects model). a Best-case scenario patch angioplasty. b Worst-case scenario patch angioplasty

Fig. 7

Forest plot on > 30 days mortality (random-effects model). a Best-case scenario patch angioplasty. b Worst-case scenario patch angioplasty

Fig. 8

Forest plot on serious adverse events (random-effects model). a Best-case scenario patch angioplasty. b Worst-case scenario patch angioplasty

Fig. 9

Forest plot on symptomatic or asymptomatic arterial occlusion or restenosis (50 to 99%) (random-effects model)

Fig. 10

Forest plot on < 30 days stroke (random-effects model). a Forest plot on < 30 days stroke. Best-case scenario patch angioplasty. b Forest plot on < 30 days stroke. Worst-case scenario patch angioplasty