Dataset Information

Safety and efficacy of transcarotid artery revascularisation versus carotid endarterectomy: protocol for a systematic review and meta-analysis study.

ABSTRACT:

Introduction

In recent years, the transcarotid artery revascularisation (TCAR) with flow reversal technique has been developed to treat carotid artery stenosis. The superiority of TCAR over transfemoral carotid artery stenting has been demonstrated. However, the safety and efficacy of TCAR and carotid endarterectomy remain unclear. This study aims to introduce a protocol for a systematic review and meta-analysis to compare the morbidity and mortality rates between TCAR and carotid endarterectomy in the treatment of atherosclerotic carotid artery stenosis.

Methods and analysis

This protocol was drafted using the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement. Herein, major databases will be searched, including Medline, Web of Science, Embase and the Cochrane Library, and randomised controlled trials and high-quality observational studies will be included. We will screen all studies published from January 2000 to March 2021. Bias risk will be evaluated using the Cochrane Collaboration criteria or Methodological Index for Non-randomised Studies criteria, depending on the study type. Two reviewers will select eligible studies and extract the data independently. The primary outcome will include stroke or death during the perioperative period and follow-up. Subgroup and sensitivity analyses will be performed to explore any potential sources of heterogeneity. Specific results will be described in a narrative form when available eligible studies are insufficient for meta-analysis. Publication bias will be assessed using a funnel plot.

Ethics and dissemination

This study will summarise and analyse the existing literature; hence, ethics approval will not be required. The final results may be published at a relevant academic conference or in a journal.

Prospero registration number

CRD42020178691.

SUBMITTER: Bai X

PROVIDER: S-EPMC8098965 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:ImportanceA transcarotid artery revascularization (TCAR) device was approved by the US Food and Drug Administration in 2015 for carotid revascularization in patients at high risk for stroke, cranial nerve injury, or major cardiac event. It is unclear how the introduction of TCAR has changed the use of carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS).ObjectiveTo quantify the temporal changes in the operative approach to carotid revascularization (CEA vs TFCAS vs TCAR), and to identify patient and disease characteristics commonly associated with each approach.Design, setting, and participantsThis retrospective cohort study obtained data from the Vascular Quality Initiative database from January 1, 2015, to December 31, 2019. Patients with carotid artery stenosis who underwent CEA, TFCAS, or TCAR were included. Data were analyzed from January to April 2022.ExposuresMonth and year of surgery as well as patient risk status.Main outcomes and measuresNumber and proportion of carotid revascularization procedures by operative approach.ResultsA total of 108 676 patients (mean [SD] age 56.6 [12.5] years; 66 684 men [61.4%]) were included in the analysis. The most common operative approach overall was CEA (n = 81 508 [75.0%]), followed by TFCAS (n = 15 578 [14.3%]) and TCAR (n = 11 590 [10.7%]). The number of procedures increased over the study period (16 754 in 2015 vs 27 269 in 2019; P < .001). In 2015, CEA was used in 84.9% of all cases, followed by TFCAS (14.4%) and TCAR (0.8%). In 2019, CEA was used in 64.8% of cases, followed by TCAR (21.9%) and TFCAS (13.3%). The proportional use of CEA decreased by 5.0% (95% CI, -7.4% to -2.6%) per year, and TCAR use increased by 5.3% (95% CI, 2.3%-8.3%) per year. Among patients at high risk, the change was greater: CEA use decreased by 7.8% (95% CI, -11.9% to -3.8%) per year, TFCAS decreased by 4.8% (95% CI, -9.5% to -0.14%) per year, and TCAR increased by 12.6% (95% CI, 7.1%-18.1%) per year. Multinomial logistic regression showed that patient risk status was the most important characteristic associated with TCAR compared with CEA (relative risk ratio, 36.10; 95% CI, 29.24-44.66; P < .001) and TFCAS (relative risk ratio, 14.10; 95% CI, 11.86-16.66; P < .001). Linear regression revealed no association between year of surgery and in-hospital myocardial infarction, stroke, or mortality.Conclusions and relevanceResults of this study indicate that TCAR has become the dominant carotid revascularization approach, surpassing TFCAS and CEA in patients at high risk for stroke, cranial nerve injury, or cardiovascular events. Patient high-risk status was the main characteristic associated with a stenting approach, highlighting the perceived importance of carotid stenting therapies in this patient population.

Project description:BackgroundCarotid-artery stenting and carotid endarterectomy are both options for treating carotid-artery stenosis, an important cause of stroke.MethodsWe randomly assigned patients with symptomatic or asymptomatic carotid stenosis to undergo carotid-artery stenting or carotid endarterectomy. The primary composite end point was stroke, myocardial infarction, or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization.ResultsFor 2502 patients over a median follow-up period of 2.5 years, there was no significant difference in the estimated 4-year rates of the primary end point between the stenting group and the endarterectomy group (7.2% and 6.8%, respectively; hazard ratio with stenting, 1.11; 95% confidence interval, 0.81 to 1.51; P=0.51). There was no differential treatment effect with regard to the primary end point according to symptomatic status (P=0.84) or sex (P=0.34). The 4-year rate of stroke or death was 6.4% with stenting and 4.7% with endarterectomy (hazard ratio, 1.50; P=0.03); the rates among symptomatic patients were 8.0% and 6.4% (hazard ratio, 1.37; P=0.14), and the rates among asymptomatic patients were 4.5% and 2.7% (hazard ratio, 1.86; P=0.07), respectively. Periprocedural rates of individual components of the end points differed between the stenting group and the endarterectomy group: for death (0.7% vs. 0.3%, P=0.18), for stroke (4.1% vs. 2.3%, P=0.01), and for myocardial infarction (1.1% vs. 2.3%, P=0.03). After this period, the incidences of ipsilateral stroke with stenting and with endarterectomy were similarly low (2.0% and 2.4%, respectively; P=0.85).ConclusionsAmong patients with symptomatic or asymptomatic carotid stenosis, the risk of the composite primary outcome of stroke, myocardial infarction, or death did not differ significantly in the group undergoing carotid-artery stenting and the group undergoing carotid endarterectomy. During the periprocedural period, there was a higher risk of stroke with stenting and a higher risk of myocardial infarction with endarterectomy. (ClinicalTrials.gov number, NCT00004732.)

Project description:Objectives Transcarotid arterial revascularization (TCAR) is associated with a lower risk of stroke or death than transfemoral carotid artery stenting (TF-CAS). TCAR infers a lower risk of cranial nerve injury and a similar risk of myocardial infarction (MI) than carotid endarterectomy (CEA). There have been no comparative studies on the cost of TCAR, TF-CAS, and CEA, which may have important implications for institutional support for the new modality to address carotid artery stenosis. Our aim was to compare the estimated cost profiles of TCAR, TF-CAS, and CEA. Methods A review was performed on Medicare patients who underwent TCAR, TF-CAS, or CEA between January 1, 2020, and December 31, 2020. Demographics, comorbidities, operative details, and postoperative complications were reviewed. Acute stroke presentations and elective procedures were included. Cost data were obtained from the hospital's finance department. Quantitative variables were compared using analysis of variance, and categorical variables were compared using the chi-square analysis. Results In total, 21 TCAR, 97 TF-CAS, and 26 CEA patients were initially identified. After removing the non-Medicare patients, 17 TCAR, 57 TF-CAS, and 13 CEA patients were included in the analysis. In-hospital stroke, MI, and mortality included three deaths in TF-CAS patients. At 30 days, the stroke rates for TCAR, TF-CAS, and CEA groups were 0%, 1.8%, and 0%, respectively. The payments for TCAR, TF-CAS, and CEA were $15,400 ± 2,100, $23,400 ± 11,800 and $14,300 ± 5,700 (p=0.001), respectively. The estimated costs for TCAR, TF-CAS, and CEA were $10,500 ± 3,300, $13,800 ± 14,300, and $12,400 ± 6,000 (p=0.575), respectively. The profit margins for TCAR, TF-CAS, and CEA were $5,100 ± 3,100, $9,600 ± 12,100, and $1,900 ± 6,400 (p=0.032), respectively. There was no significant difference in American Society of Anesthesiologists (ASA) scores (p=0.635) or age (p=0.485) among the three groups. The length of hospital stay was not significantly different (p=0.107). The TF-CAS maintained the highest profit margin (p<0.001) when matched for the same diagnosis-related code (without complications or comorbidities). Urgency classification within the TF-CAS group included 45 elective, four urgent, and eight emergent cases. The profit margin was significantly higher for the elective group than for the emergent group (p=0.002) but not different for elective versus urgent (p=0.503) or urgent versus emergent (p=0.102). All patients who underwent TCAR and CEA were elective. Conclusion The hospital reimbursement and profit margins are higher for TF-CAS than for TCAR. With the increasing data now demonstrating similar outcomes with TF-CAS and CEA, further research is required to examine the long-term cost-effectiveness of TCAR and how this will compare to TF-CAS.

Project description:BackgroundThe internet is becoming increasingly more important in the new era of patient self-education. Carotid endarterectomy (CEA) and carotid artery stenting (CAS) are recognized interventions to treat patients with carotid artery stenosis. Using the Google search platform, patients encounter many websites with conflicting information, which are sometimes difficult to understand. This lack of accessibility creates uncertainty or bias toward interventions for carotid artery disease. The quality, readability, and treatment preference of carotid artery disease (CAD) websites have not yet been evaluated.ObjectiveThis study aimed to explore the quality, readability, and treatment preference of CAD websites.MethodsWe searched Google Canada for 10 CAD-related keywords. Returned links were assessed for publication date, medical specialty and industry affiliation, presence of randomized controlled trial data, differentiation by symptomatic status, and favored treatment. Website quality and readability were rated by the DISCERN instrument and Gunning Fog Index.ResultsWe identified 54 unique sites: 18 (33.3%) by medical societies or individual physicians, 11 (20.4%) by government organizations, 9 (16.7%) by laypersons, and 1 (1.9%) that was industry-sponsored. Of these sites, 26 (48.1%) distinguished symptomatic from asymptomatic CAD. A majority of sites overall (57.4%) and vascular-affiliated (72.7%) favored CEA. In contrast, radiology- and cardiology-affiliated sites demonstrated the highest proportion of sites favoring CAS, though they were equally likely to favor CEA. A large proportion (21/54, 38.9%) of sites received poor quality ratings (total DISCERN score <48), and the majority (41/54, 75.9%) required a reading level greater than a high school senior.ConclusionsCAD websites are often produced by government organizations, medical societies, or physicians, especially vascular surgeons. Sites ranged in quality, readability, and differentiation by symptomatic status. Google searches of CAD-related terms are more likely to yield sites favoring CEA. Future research should determine the extent of website influence on CAD patients' treatment decisions.

Project description:BackgroundIn the Carotid Revascularization Endarterectomy versus Stenting Trial, we found no significant difference between the stenting group and the endarterectomy group with respect to the primary composite end point of stroke, myocardial infarction, or death during the periprocedural period or any subsequent ipsilateral stroke during 4 years of follow-up. We now extend the results to 10 years.MethodsAmong patients with carotid-artery stenosis who had been randomly assigned to stenting or endarterectomy, we evaluated outcomes every 6 months for up to 10 years at 117 centers. In addition to assessing the primary composite end point, we assessed the primary end point for the long-term extension study, which was ipsilateral stroke after the periprocedural period.ResultsAmong 2502 patients, there was no significant difference in the rate of the primary composite end point between the stenting group (11.8%; 95% confidence interval [CI], 9.1 to 14.8) and the endarterectomy group (9.9%; 95% CI, 7.9 to 12.2) over 10 years of follow-up (hazard ratio, 1.10; 95% CI, 0.83 to 1.44). With respect to the primary long-term end point, postprocedural ipsilateral stroke over the 10-year follow-up occurred in 6.9% (95% CI, 4.4 to 9.7) of the patients in the stenting group and in 5.6% (95% CI, 3.7 to 7.6) of those in the endarterectomy group; the rates did not differ significantly between the groups (hazard ratio, 0.99; 95% CI, 0.64 to 1.52). No significant between-group differences with respect to either end point were detected when symptomatic patients and asymptomatic patients were analyzed separately.ConclusionsOver 10 years of follow-up, we did not find a significant difference between patients who underwent stenting and those who underwent endarterectomy with respect to the risk of periprocedural stroke, myocardial infarction, or death and subsequent ipsilateral stroke. The rate of postprocedural ipsilateral stroke also did not differ between groups. (Funded by the National Institutes of Health and Abbott Vascular Solutions; CREST ClinicalTrials.gov number, NCT00004732.).