Dataset Information

Systematic review of randomized controlled trials of different types of patch materials during carotid endarterectomy.

ABSTRACT:

Background and purpose

Carotid endarterectomy (CEA) with patch angioplasty produces greater results than with primary closure; however, there remains uncertainty on the optimal patch material in CEA. A systematic review of randomized controlled trials (RCTs) was performed to evaluate the effect of angioplasty using venous patch versus synthetic patch material, and Dacron patch versus polytetrafluoroethelene (PTFE) patch material during CEA.

Methods

A multiple electronic health database screening was performed including the Cochrane library, Pubmed, Ovid, EMBASE and Google Scholar on all randomized controlled trials (RCTs) published before November 2012 that compared the outcomes of patients undergoing CEA with venous patch versus synthetic patch. RCTs were included if they compared carotid patch angioplasty with autologus venous patch versus synthetic patch material, or compared one type of synthetic patch with another.

Results

Thirteen RCTs were identified. Ten trials, involving 1946 CEAs, compared venous patch with synthetic patch materials. Two trials, involving 400 CEAs in 380 patients, compared Dacron patch with PTFE patch. The hemostasis time in CEA with PTFE patch was significantly longer than with venous patch (P<0.0001), and longer than with Dacron patch (P<0.0001). There was no significant difference of mortality rate, stroke rate, restenosis, and operative time in CEA with venous patch versus synthetic patch material, or in CEA with Dacron patch versus PTFE patch (all P>0.05). One RCT of 95 CEAs in 92 patients compared bovine pericardium with Dacron patch, and demonstrated a statistically significant decrease in intraoperative suture line bleeding with bovine pericardium compared with Dacron patch (P<0.001).

Conclusions

The hemostasis time in CEA with PTFE patch was longer than with venous patch or Dacron patch. The overall perioperative and long-term mortality rate, stroke rate, restenosis, and operative time were similar when using venous patch versus synthetic patch material or Dacron patch versus PTFE patch material during CEA. More data are required to clarify differences between different patch materials.

SUBMITTER: Ren S

PROVIDER: S-EPMC3561447 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Systematic review of randomized controlled trials of different types of patch materials during carotid endarterectomy.

Ren Shiyan S Li Xianlun X Wen Jianyan J Zhang Wenjian W Liu Peng P

PloS one 20130131 1

<h4>Background and purpose</h4>Carotid endarterectomy (CEA) with patch angioplasty produces greater results than with primary closure; however, there remains uncertainty on the optimal patch material in CEA. A systematic review of randomized controlled trials (RCTs) was performed to evaluate the effect of angioplasty using venous patch versus synthetic patch material, and Dacron patch versus polytetrafluoroethelene (PTFE) patch material during CEA.<h4>Methods</h4>A multiple electronic health dat ...[more]

PMID: 23383053

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Project description:BACKGROUND:Many recent trials have investigated the long-term efficacy and safety of endarterectomy versus stenting in treating patients with carotid artery stenosis. We aimed to determine the long-term comparative efficacy and safety of both procedures by pooling this evidence in a meta-analysis. METHODS:We searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials for studies published until May 6, 2016. Randomized controlled trials, which reported outcomes of interest with a median follow-up of at least 4-year, were included. RESULTS:Eight trials involving 7005 patients and 41824 patient-years of follow-up were included. In terms of the periprocedural outcomes, stenting was associated with a lower risk of myocardial infarction (OR: 0.51; 95% CI: 0.33 to 0.80; P = 0.003) but a higher risk of death or stroke (the composite endpoint, OR: 1.76; 95% CI: 1.38 to 2.25; P < 0.0001), a result that was primarily driven by minor stroke (OR: 2.19; 95% CI: 1.59 to 3.01; P < 0.0001), less so by periprocedural death (OR: 1.68; 95% CI: 0.82 to 3.44; P = 0.16) and major stroke (OR: 1.41; 95% CI: 0.95 to 2.09; P = 0.09). In terms of the long-term outcomes, stenting was associated with a higher risk of stroke (OR 1.45; 95% CI: 1.22 to 1.73; P < 0.0001) and the composite outcome of death or stroke (OR 1.25; 95% CI: 1.05 to 1.48; P = 0.01). No difference was found in long-term all-cause mortality between stenting and endarterectomy (OR: 1.09; 95% CI: 0.95 to 1.26; P = 0.21) and restenosis (OR: 1.48 (95% CI: 0.93 to 2.35; P = 0.10). No evidence of significant heterogeneity was found in any of the analyses. CONCLUSIONS:Carotid endarterectomy was found to be superior to stenting for short- and long-term outcomes, although endarterectomy was associated with a higher risk of periprocedural myocardial infarction. Carotid endarterectomy should be offered as the first choice for carotid stenosis at present, however, more evidence is needed because rapid progress in concurrent devices and medical treatments is being made.

Project description:BackgroundPatch 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.MethodsSearches (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.ResultsWe 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.ConclusionsThis 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 registrationPROSPERO CRD42014013416 . Review protocol publication 2019 DOI: https://doi.org/10.1136/bmjopen-2018-026419 .

Project description: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 plexus anesthesia or general anesthesia in traditional carotid endarterectomy is, to date, not unequivocally proven to be superior to one other. A systematic review is needed for evaluation of benefits and harms to determine which technique, plexus anesthesia or general anesthesia is more effective for traditional carotid endarterectomy 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. Randomized Clinical Trials comparing plexus anesthesia versus general anesthesia in traditional carotid endarterectomy will be included. Primary outcomes will be postoperative death and/ or stroke (<30 days) and serious adverse events. Secondary outcomes will be non-serious adverse events.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 confidence interval precision of the estimate achieved in all trials as the result of our meta-analyses.Ethics and disseminationThe proposed systematic review will collect and analyze secondary data from already performed studies therefore 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.

Project description:Background and purposeCREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) reported a higher periprocedural risk for any stroke, death, or myocardial infarction for women randomized to carotid artery stenting (CAS) compared with women randomized to carotid endarterectomy (CEA). No difference in risk by treatment was detected for women relative to men in the 4-year primary outcome. We aimed to conduct a pooled analysis among symptomatic patients in large randomized trials to provide more precise estimates of sex differences in the CAS-to-CEA risk for any stroke or death during the 120-day periprocedural period and ipsilateral stroke thereafter.MethodsData from the Carotid Stenosis Trialists' Collaboration included outcomes from symptomatic patients in EVA-3S (Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis), SPACE (Stent-Protected Angioplasty Versus Carotid Endarterectomy in Symptomatic Patients), ICSS (International Carotid Stenting Study), and CREST. The primary outcome was any stroke or death within 120 days after randomization and ipsilateral stroke thereafter. Event rates and relative risks were estimated using Poisson regression; effect modification by sex was assessed with a sex-by-treatment-by-trial interaction term, with significant interaction defined a priori as P≤0.10.ResultsOver a median 2.7 years of follow-up, 433 outcomes occurred in 3317 men and 1437 women. The CAS-to-CEA relative risk of the primary outcome was significantly lower for women compared with men in 1 trial, nominally lower in another, and nominally higher in the other two. The sex-by-treatment-by-trial interaction term was significant (P=0.065), indicating heterogeneity among trials. Contributors to this heterogeneity are primarily differences in periprocedural period. When the trials are nevertheless pooled, there were no significant sex differences in risk in any follow-up period.ConclusionsThere were significant differences between trials in the magnitude of sex differences in treatment effect (CAS-to-CEA relative risk), indicating pooling data from these trials to estimate sex differences might not be valid. Whether sex is acting as an effect modifier of the CAS-to-CEA treatment effect in symptomatic patients remains uncertain. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00190398 (EVA-3S) and NCT00004732 (CREST). URL: https://www.isrctn.com; Unique identifier: ISRCTN57874028 (SPACE) and ISRCTN25337470 (ICSS).

Project description: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.

Project description:ObjectiveTo evaluate the relative short term safety and intermediate term efficacy of carotid endarterectomy versus carotid artery stenting.DesignSystematic review and meta-analysis.Data sourcesBIOSIS, Embase, Medline, the Cochrane central register of controlled trials, International Pharmaceutical Abstracts database, ISI Web of Science, and Google scholar and bibliographies, from 1 January 1990 to 25 July 2009.Study selectionRandomised controlled trials comparing carotid endarterectomy with carotid artery stenting in patients with carotid artery stenosis with or without symptoms.Data extractionPrimary end point was a composite of mortality or stroke. Secondary end points were death, stroke, myocardial infarction, or facial neuropathy (as individual end points), and mortality or disabling stroke (as a composite end point).Data synthesis11 trials were included (4796 patients); 10 reported on short term outcomes (n=4709) and nine on intermediate term outcomes (1-4 years). The periprocedural risk of mortality or stroke was lower for carotid endarterectomy (odds ratio 0.67, 95% confidence interval 0.47 to 0.95; P=0.025) than for carotid stenting, mainly because of a decreased risk of stroke (0.65, 0.43 to 1.00; P=0.049), whereas the risk of death (1.14, 0.56 to 2.31; P=0.727) and the composite end point mortality or disabling stroke (0.74, 0.53 to 1.05; P=0.088) did not differ significantly. The odds of periprocedural myocardial infarction (2.69, 1.06 to 6.79; P=0.036) or cranial nerve injury (10.2, 4.0 to 26.1; P<0.001) was higher in the carotid endarterectomy group than in the carotid stenting group. In the intermediate term, the two treatments did not differ significantly for stroke or death (hazard ratio 0.90, 95% confidence interval 0.74 to 1.1; P=0.314).ConclusionsCarotid endarterectomy was found to be superior to carotid artery stenting for short term outcomes but the difference was not significant for intermediate term outcomes; this difference was mainly driven by non-disabling stroke. Significantly fewer cranial nerve injuries and myocardial infarctions occurred with carotid artery stenting.

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.

Project description:BackgroundIntraoperative arterial hypotension can lead to severe complications in patients undergoing carotid endarterectomy, in particular if cerebral auto-regulation is impaired. Short-acting agents, such as phenylephrine or ephedrine, commonly used to correct intra-operative hypotension, have different hemodynamic effects. Recently, it was reported that, in healthy anesthetized subjects with intact cerebral auto-regulation, frontal lobe cerebral tissue oxygenation declined after phenylephrine bolus administration, while it was preserved after ephedrine use (Br J Anaesth 107:209-217, 2011; Neurocrit Care 12:17-23, 2010). However, the effect of both agents in patients undergoing carotid endarterectomy is unknown. The aim of this study is to assess the effect of two routinely used vasopressors (phenylephrine and ephedrine) on the cerebral hemodynamics during carotid endarterectomy.Methods/designPatients undergoing carotid endarterectomy will be prospectively included and randomized for correction of intraoperative hypotension with either phenylephrine (50 to 100 μg) or ephedrine (5 to 10 mg). If hypotension persists for more than five minutes after treatment, the patient will be classified as a non-responder and escape medication as preferred by the anesthesiologist will be administered. Changes in cerebral hemodynamics will be quantified by changes in transcranial Doppler-derived middle cerebral artery blood velocity and near infra-red spectroscopy-derived frontal lobe cerebral tissue oxygenation, when intra-operative hypotension is treated with phenylephrine or ephedrine in patients who undergo carotid endarterectomy with or without an adequate functioning cerebral auto-regulation.To quantify whether the intra-operative cerebral auto-regulation is impaired or not, a decrease in breathing frequency from the normal 12 breaths per minute to 6 breaths per minute for an episode of three minutes will be performed.DiscussionPhenylephrine and ephedrine are two of the most commonly used short-acting agents to increase blood pressure in clinical anesthesiologic practice. Monitoring of middle cerebral artery blood velocity with transcranial Doppler and frontal lobe cerebral tissue oxygenation with near infra-red spectroscopy are part of the standard of care. Furthermore, there are no reports that the three-minute modification in breathing frequency described in the "intervention"-section is harmful. Therefore, the risks for participating patients are negligible and the burden minimal.Trial registrationClinical trials.gov: NCT01451294.

Dataset Information

Systematic review of randomized controlled trials of different types of patch materials during carotid endarterectomy.

Background and purpose

Methods

Results

Conclusions

Publications

Systematic review of randomized controlled trials of different types of patch materials during carotid endarterectomy.

Similar Datasets

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