Comparing Carotid Endarterectomy Research Articles

Patch angioplasty carotid endarterectomy versus eversion carotid endarterectomy.

To compare carotid endarterectomy patch angioplasty (p-CEA) with eversion carotid endarterectomy (e-CEA) and associated risks of early cardio-cerebrovascular complications. The study was a prospective randomized single-blind trial, monocentric, clinically applicable, descriptive analytical and comparative. From June 2021 to June 2023, 62 consecutive patients with symptomatic and asymptomatic stenosis of the internal carotid artery, admitted to our department and randomized into two groups: carotid endarterectomy with patch angioplasty and eversion carotid endarterectomy. Follow-up for 30 days after surgery. During surgery e-CEA, 70% patients had an arrhythmia, and 24 hours after 66.7%, seven days after 46.7% and month after 13.3%. During surgery p-CEA, 33.3% patients had an arrhythmia, 24 hours later 33.3%, 7 days after 13.3% and 30 days after 13.3% patients. Statistically significant difference observed during surgery (Fishers p=0.004). One day after the surgery rate of patients with arrhythmia that were treated e-CEA has decreased, but it was still higher than after p-CEA (Fishers p=0.010). The frequency and categorization of postoperative cardiac arrhythmias after eversion carotid endarterectomy, the clinical implications of various postoperative heart rhythm disturbances and their long-term effects on patients need to be further investigate through sufficiently powered randomized controlled studies.

Comparing Post-operative Pain and Other Outcomes in Carotid Endarterectomy Versus Transcarotid Artery Revascularization.

Transcarotid artery revascularization (TCAR) is growing in popularity. Although major clinical end-points such as stroke rate and mortality are well-known, patient reported outcomes such as pain, and length of stay are among the purported benefits that are as yet untested. We sought to determine if there are differences in pain and other clinical outcomes when comparing carotid endarterectomy (CEA) and TCAR. We performed a retrospective review of 326 patients undergoing TCAR (n = 50) or CEA (n = 276) from 2019-2023. Primary outcomes of interest were maximum pain numeric rating scales (NRS) reported in the post-anesthesia care unit (PACU) and on postoperative days (POD) zero and 1, and oral morphine milligram equivalents (OMMEs) received intraoperatively through POD1. Secondary outcomes included length of stay (LOS), complications, and 30-day emergency department (ED) returns/readmissions. Fifty TCAR and 150 CEA patients were included in the propensity score matched cohorts. TCAR patients reported lower pain-NRS in PACU (P < .001) and on POD0 (P = .002), but similar pain scores on POD1 (P = .112). Postoperatively, TCAR patients were less likely to receive opioids (52% vs 75.3%, P = .003) and received less OMME from PACU through POD1 (12.8 ± 16.2 vs 23.2 ± 27.2, P = .001). After adjusting for age, sex, BMI, prior chronic opioid use, and prior carotid surgery, TCAR patients were approximately 70% less likely to receive post-operative opioids. No significant differences in LOS, 30-day ED returns/readmissions, or complications were observed between groups. Compared with CEA, patients undergoing TCAR reported lower pain scores and consumed fewer narcotics overall. However, the absolute difference was modest, and pain scores were low in both cohorts. Differences in pain and post-operative narcotic use may be of less importance when deciding between TCAR and CEA. Total non-opioid protocols may be feasible in both approaches.

P.124 Assessing the fragility index of randomized controlled trials on carotid artery stenosis: systematic review

Background: The fragility index (FI) is the minimum number of patients whose status would have to change from a nonevent to an event to turn a statistically significant result to a non-significant result. We used this to measure the robustness of trials comparing carotid endarterectomy (CEA) to carotid artery stenting (CAS). Methods: A search was conducted in MEDLINE, Embase, and PubMed on RCTs comparing CEA to CAS. The trials need to have statistically significant results and dichotomous primary endpoints to be included. Results: Our literature search identified 10 RCTs which included 9382 patients (4734 CEA, 4648 CAS). The primary end points of all included trials favoured CEA over CAS. The median FI was 9.5 (interquartile range 2.25 - 21.25). All of the studies that reported lost-to-follow-up (LTFU) had LTFU greater than its fragility index, which raises concern that the missing data could change the results of the trial from statistically significant to statistically insignificant. Conclusions: A small number of events (FI, median 9.5) were required to render the results of carotid artery stenosis RCTs comparing CEA to CAS statistically insignificant. All of the studies that reported LTFU had LTFU greater than its fragility index.

Long-term durability and clinical outcome of a prospective randomized trial comparing carotid endarterectomy with ACUSEAL polytetrafluoroethylene patching versus pericardial patching: Presented at the Forty-seventh Annual Meeting of Southern Association of Vascular Surgery, Puerto Rico, January 18-21, 2023.

Background: Several studies have shown the superiority of carotid endarterectomy (CEA) with patch closure over primary closure. However, no definite study has shown any significant differences in clinical outcome between various types of patches. Because more vascular surgeons have used pericardial patching recently, this study will analyze the late clinical outcome (≥10 years) of our previously reported prospective randomized trial comparing CEA with ACUSEAL (polytetrafluoroethylene) vs pericardial patching.

Long-term durability and clinical outcome of a prospective randomized trial comparing carotid endarterectomy with ACUSEAL polytetrafluoroethylene patching versus pericardial patching

BackgroundSeveral studies have shown the superiority of carotid endarterectomy (CEA) with patch closure over primary closure. However, no definite study has shown any significant differences in clinical outcome between various types of patches. Because more vascular surgeons have used pericardial patching recently, this study will analyze the late clinical outcome (≥10 years) of our previously reported prospective randomized trial comparing CEA with ACUSEAL (polytetrafluoroethylene) vs pericardial patching. MethodsA total of 200 CEAs were randomized (1:1) to either Vascu-Guard pericardial patching or ACUSEAL patching. All patients had immediate duplex ultrasound imaging, which was repeated at 6 months and annually thereafter. Kaplan-Meier analysis was used to estimate rates of freedom from stroke, stroke-free survival, and rates of freedom from ≥50% and ≥80% restenosis. ResultsOverall demographic and clinical characteristics were somewhat similar with a mean follow-up of 80 months (range: 0-149 months). The rates of freedom from stroke were 97, 97, 97, 96, 93 for ACUSEAL vs 99, 98, 97, 97, 92 for pericardial patching (P = .1112) at 1, 2, 3, 5, and 10 years, respectively. Similarly, the rates of freedom from stroke/death were 94, 93, 90, 76, 50 for ACUSEAL vs 99, 96, 91, 78, 47 for pericardial patching (P = .8591). The rates of freedom from ≥50% restenosis were 98, 98, 96, 89, 79 for ACUSEAL vs 87, 83, 83, 81, 71 for pericardial patching (P = .0489). The rates of freedom from ≥80% restenosis were 99, 99, 99, 96, 85 for ACUSEAL vs 96, 96, 96, 93, 93 for pericardial patching (P = .9407). The overall survival rates were 95, 94, 91, 77, 51 for ACUSEAL vs 100, 98, 93, 79, 50 for pericardial patching (P = .9123). Other patch complications (eg, rupture, aneurysmal dilation, infection, etc) were similar. ConclusionsBoth CEA with ACUSEAL (polytetrafluoroethylene) and pericardial patching are durable and have similar clinical outcomes at 10 years except that ACUSEAL patching has significantly better rates of freedom from ≥50% restenosis.

Outcomes Following Carotid Endarterectomy and Carotid Artery Stenting in Patients with Carotid Artery Stenosis: A Retrospective Study from a Single Center in South Korea.

BACKGROUND Previous randomized controlled trials and meta-analyses comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS) included a large number of patients, but the diagnosis, treatment selection, and performance were heterogeneous. This retrospective study from a single center in South Korea aimed to evaluate outcomes following CEA and CAS in patients with carotid artery stenosis. MATERIAL AND METHODS A retrospective analysis was performed using the data of patients who underwent carotid revascularization between September 2016 and June 2021 at a single institution. The primary outcomes were stroke, myocardial infarction (MI), and death during the periprocedural period. RESULTS We enrolled a total of 61 (44 symptomatic and 17 asymptomatic) patients who underwent CEA or CAS. Among them, 36 (59%) underwent CEA and 25 (41%) underwent CAS. Statistically significant differences were found between the groups in degree of carotid stenosis (CEA: 87.0±9.1, CAS: 80.5±9.3, P=0.007). All patients with confirmed plaque ulceration before carotid revascularization underwent CEA. Two (3.3%) periprocedural strokes occurred, 1 in each group, on the ipsilateral side. There were no significant differences between CEA and CAS in the event-free survival rate for stroke during the follow-up (log-rank test=0.806). CONCLUSIONS Favorable outcomes in terms of periprocedural stroke were observed. We found no significant difference between the 2 carotid revascularization techniques in the incidence of periprocedural stroke in symptomatic and asymptomatic patients. To confirm our findings, further studies involving a larger number of patients and continuous follow-up are necessary.

External Validity of Randomised Controlled Trials on Carotid Revascularisation: Trial Populations May Not Always Reflect Patients in Clinical Practice

The external validity of randomised controlled trials (RCTs) and their transferability to clinical practice is under investigated. This study aimed to analyse the exclusion criteria of recent carotid RCTs comparing carotid endarterectomy (CEA) and carotid artery stenting, and to assess the eligibility of consecutive clinical practice cohorts to those RCTs. An analysis of the clinical and anatomical exclusion criteria of RCTs for asymptomatic (SPACE-2, ACST-2, CREST-1, and CREST-2) and symptomatic carotid stenosis (SPACE-1, CREST-1, ICSS, and EVA-3S) was performed. Two hundred consecutive asymptomatic and 200 consecutive symptomatic patients, treated by CEA, or transfemoral or transcarotid artery stenting at a tertiary referral university centre were assessed for their potential eligibility for each corresponding RCT. RCT patient data were pooled and differences from the clinical practice cohort analysed. Statistics were descriptive and comparative using Fisher's exact and t tests. The number of clinical and anatomical exclusion criteria differed widely between RCTs. Potential eligibility rates of the clinical practice cohort for RCTs with regard to asymptomatic carotid stenosis were 80.5% (ACST-2), 79.5% (SPACE-2), 47% (CREST-1), and 20% (CREST-2). For RCTs on symptomatic carotid stenosis the eligibility rates were 89% (ICSS), 86.5% (EVA-3S), 64% (SPACE-1), and 39% (CREST-1). Both clinical practice cohorts were older by about three years and patients were more often male vs. the RCTs. Furthermore, a history of smoking (asymptomatic patients), hypertension (symptomatic patients), and atrial fibrillation was diagnosed more often, whereas hypercholesterolaemia and coronary heart disease (asymptomatic patients) were less prevalent. More clinical practice patients were on antiplatelets, anticoagulants, and lipid lowering drugs. Symptomatic clinical practice patients presented more often with retinal ischaemia and less often with minor hemispheric strokes than patients in the RCTs. The external validity of contemporary carotid RCTs varies considerably. Patients in routine clinical practice differ from RCT populations with respect to age, comorbidities, and medication. These data are of interest for clinicians and guideline authors and may be relevant for the design of future comparative trials.

Society for Vascular Surgery clinical practice guidelines for management of extracranial cerebrovascular disease.

Management of carotid bifurcation stenosis in stroke prevention has been the subject of extensive investigations, including multiple randomized controlled trials. The proper treatment of patients with carotid bifurcation disease is of major interest to vascular surgeons and other vascular specialists. In 2011, the Society for Vascular Surgery published guidelines for the treatment of carotid artery disease. At the time, several randomized trials, comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS), were reported. Since the 2011 guidelines, several studies and a few systematic reviews comparing CEA and CAS have been reported, and the role of medical management has been reemphasized. In the present publication, we have updated and expanded on the 2011 guidelines with specific emphasis on five areas: (1) is CEA recommended over maximal medical therapy for low-risk patients; (2) is CEA recommended over transfemoral CAS for low surgical risk patients with symptomatic carotid artery stenosis of >50%; (3) the timing of carotid intervention for patients presenting with acute stroke; (4) screening for carotid artery stenosis in asymptomatic patients; and (5) the optimal sequence of intervention for patients with combined carotid and coronary artery disease. A separate implementation document will address other important clinical issues in extracranial cerebrovascular disease. Recommendations are made using the GRADE (grades of recommendation assessment, development, and evaluation) approach, as was used for other Society for Vascular Surgery guidelines. The committee recommends CEA as the first-line treatment for symptomatic low-risk surgical patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 70% to 99%. The perioperative risk of stroke and death in asymptomatic patients must be<3% to ensure benefit for the patient. In patients with recent stable stroke (modified Rankin scale score, 0-2), carotid revascularization is considered appropriate for symptomatic patients with >50% stenosis and should be performed as soon as the patient is neurologically stable after 48hours but definitely<14days after symptom onset. In the general population, screening for clinically asymptomatic carotid artery stenosis in patients without cerebrovascular symptoms or significant risk factors for carotid artery disease is not recommended. In selected asymptomatic patients with an increased risk of carotid stenosis, we suggest screening for clinically asymptomatic carotid artery stenosis as long as the patients would potentially be fit for and willing to consider carotid intervention if significant stenosis is discovered. For patients with symptomatic carotid stenosis of 50% to 99%, who require both CEA and coronary artery bypass grafting, we suggest CEA before, or concomitant with, coronary artery bypass grafting to potentially reduce the risk of stroke andstroke/death. The sequencing of the intervention depends on the clinical presentation and institutional experience.

An Analysis of Spin in Vascular Surgery Randomized Controlled Trials With Statistically Nonsignificant Primary Outcomes

Spin is the manipulation of language that distorts the interpretation of objective findings. The purpose of the present study was to describe the characteristics of spin found in statistically nonsignificant randomized controlled trials (RCTs) comparing carotid endarterectomy to carotid artery stenting for carotid stenosis (CS) and endovascular aneurysm repair to open repair for abdominal aortic aneurysms (AAAs) because they represent a significant portion of vascular surgery literature.

The Use of “Spin” in the Analysis of Nonsignificant Findings in Randomized Trials in Vascular Surgery

Spin is the manipulation of language in a way that can distort a reader's interpretation of objective scientific findings. The objective of this study was to describe the degree and prevalence of spin found in statistically nonsignificant vascular surgery randomized controlled trials (RCTs) comparing carotid endarterectomy (CEA) with carotid artery stenting (CAS) for carotid stenosis (CS), and endovascular repair (EVAR) with open repair (OR) for abdominal aortic aneurysms (AAAs).

Overview of Primary and Secondary Analyses From 20 Randomised Controlled Trials Comparing Carotid Artery Stenting With Carotid Endarterectomy

Objectives The aim of this review was to carry out primary and secondary analyses of 20 randomised controlled trials (RCTs) comparing carotid endarterectomy (CEA) with carotid artery stenting (CAS). Methods A systematic review and meta-analysis of data from 20 RCTs (126 publications) was carried out. Results Compared with CEA, the 30 day death/stroke rate was significantly higher after CAS in seven RCTs involving 3467 asymptomatic patients (odds ratio [OR] 1.64, 95% confidence interval [CI] 1.02–2.64) and in 10 RCTs involving 5797 symptomatic patients (OR 1.71, 95% CI 1.38–2.11). Excluding procedural risks, late ipsilateral stroke was about 4% at 9 years for both CEA and CAS, i.e., CAS was durable. Reducing procedural death/stroke after CAS may be achieved through better case selection, e.g., performing CEA in (i) symptomatic patients aged > 70 years; (ii) interventions within 14 days of symptom onset; and (iii) situations where stroke risk after CAS is predicted to be higher (segmental/remote plaques, plaque length > 13 mm, heavy burden of white matter lesions [WMLs], where two or more stents might be needed). New WMLs were significantly more common after CAS (52% vs. 17%) and were associated with higher rates of late stroke/transient ischaemic attack (23% vs. 9%), but there was no evidence that new WMLs predisposed towards late cognitive impairment. Restenoses were more common after CAS (10%) but did not increase late ipsilateral stroke. Restenoses (70%–99%) after CEA were associated with a small but significant increase in late ipsilateral stroke (OR 3.87, 95% CI 1.96–7.67; p Conclusions CAS confers higher rates of 30 day death/stroke than CEA. After 30 days, ipsilateral stroke is virtually identical for CEA and CAS. Key issues to be resolved include the following: (i) Will newer stent technologies and improved cerebral protection allow CAS to be performed

Risk of stroke in the periprocedural period: a literature review comparing carotid endarterectomy and stenting

Background Atherosclerosis of the carotid arteries is a pathophysiological process increasing the risk of stroke. Carotid endarterectomy (CEA) and carotid artery stenting (CAS) are two recognised procedures indicated by National Institute of Clinical Excellence (NICE) guidelines aiming to reduce the risk of stroke. However, both are associated with periprocedural complications (defined as within 30 days), particularly stroke. This review aims to identify which treatment, CAS or CEA, has a lower risk of periprocedural stroke in patients with symptomatic or asymptomatic carotid artery stenosis. Methods NICE Evidence Search identified relevant UK guidelines. Search strategies combining free-text terms searched the Cochrane Database of Systematic Reviews, MEDLINE, PubMed, CINAHL, and EMBASE for systematic reviews post-2011, and RCTs from 2015 onwards. Studies were included if they contained a comparison of CEA vs CAS with regards to periprocedural risk of stroke, and if they contained novel studies not seen in the NICE guidance. English language and full-text limits were applied. Results Searches identified 202 articles. Two reviewers performed independent screening identifying 3 guidelines, 7 systematic reviews, and 1 randomised control trial eligible for inclusion. Guidelines currently advocate usage of both procedures, unlike Scottish Guidelines (SIGN) who only support CEA. Four appraised systematic reviews found a statistically significant increase in stroke probability with CAS (p 0.05). Discussion This review’s findings suggest that CAS is associated with an increased risk of periprocedural stroke when compared to CEA. Current UK guidelines by NICE and SIGN may require revisiting and take into account the new evidence not included in the original guidelines. There is a need for ongoing research as stenting technology improves over time.

The Asymptomatic Carotid Surgery Trial-2 (ACST-2): an ongoing randomised controlled trial comparing carotid endarterectomy with carotid artery stenting to prevent stroke.

A successful open surgical operation to remove atheromatous carotid artery narrowing that has not yet caused a stroke (asymptomatic carotid stenosis) carries some procedural risk but, if completed successfully, halves patients' future annual stroke risk for at least 10 years. A newer, less invasive alternative is carotid stenting, which also carries some procedural risk, especially if the carotid lesion has recently given rise to a stroke (symptomatic carotid stenosis). For both surgery and stenting, improvements in technique (and in medication) have reduced risk. Early studies showed that treating carotid narrowing by stenting, particularly for symptomatic lesions, caused more procedural minor strokes than surgery, but more recent trials in symptomatic and in asymptomatic patients found that both procedures might now be equally safe and effective. However, low patient numbers, short follow-up of the long-term effects on stroke rates and wide confidence intervals mean that worldwide uncertainty persists between carotid surgery and carotid stenting, and national and international guidelines remain unclear as to which is generally better. The second Asymptomatic Carotid Surgery Trial (ACST-2) compares carotid endarterectomy (CEA) with carotid artery stenting (CAS) directly, randomising patients with asymptomatic carotid stenosis for whom a carotid procedure is considered definitely necessary; both procedures seem anatomically feasible, and there is substantial uncertainty as to which of the two would be better for such individuals. Although it will compare procedural risks, the trial's primary aim is to compare the long-term durability of protection against strokes occurring in the years post procedure due to any remaining or recurrent carotid disease. Randomised controlled trial comparing CEA with CAS. Hospitals in the UK and worldwide, in which carotid procedures are common. Men and women with severely stenotic atherosclerotic carotid artery disease, with or without previous stroke but with no recent symptoms from the randomised artery. CEA and CAS. (1) Periprocedural risk defined as myocardial infarction, stroke or death within 30 days after the randomised procedure and (2) long-term rates of disabling or fatal stroke during follow-up of patients. Measurement of intervention costs and stroke costs (periprocedural and during follow-up) and of quality of life [EuroQol-5 Dimensions (EQ-5D®)] for patients in the top six recruiting countries (UK, Italy, Belgium, Germany, Serbia and Sweden), who currently constitute 85% of those randomised. By the end of March 2016, ACST-2 had included 2125 patients, nearly two-thirds of the planned recruitment of 3600; 1061 were randomly allocated to CEA and 1064 to CAS. Further funding has been secured and recruitment continues, with completion anticipated by the end of 2019. ACST-2 will report initial results in 2021. Current Controlled Trials ISRCTN21144362. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 57. See the NIHR Journals Library website for further project information. Funding was also received from BUPA Foundation [BUPAF/33(a)/05].

Factors Influencing Decision Making for Carotid Endarterectomy versus Stenting in the Very Elderly.

As the population ages worldwide, the number of elderly patients with carotid stenosis is also increasing. There have been many large clinical trials comparing carotid endarterectomy (CAE) versus stenting, but the inclusion criteria (i.e., symptomatic or asymptomatic), stenting methods (i.e., protection device), and primary end point (i.e., the definition of myocardial infarction and follow-up period) were different between trials. Therefore, the interpretation of those results is difficult and requires attention. When it comes to age, the patients older than 80 years were excluded or stratified to a high risk group in previous landmark trials. However, a recent guideline recommended that endarterectomy may be associated with lower stroke risk compared with carotid artery stenting in patients older than 70 years with symptomatic carotid disease. The annual risk of stroke in individuals with asymptomatic carotid stenosis is about 1–3% but the risk is about 4–12% with symptomatic stenosis without carotid intervention. Although the outcome of CAE is better than that of carotid stenting in patients older than 70 years, the perioperative risk is higher in older patients. Therefore, it is important to classify high risk patients and consider underlying disability and life expectancy of very elderly patients before deciding whether to undergo a carotid intervention. In addition, we should also consider that the stroke rate with intensive medical treatment is unknown and is currently being investigated in randomized controlled trials. Intensive medical treatment includes high intensity statins, diabetes and blood pressure control, and aggressive antiplatelet treatment. The aim of this review is to report the factors that may be responsible for the variability in the treatment of carotid stenosis, particularly in the elderly population. This will allow the readers to integrate the current available evidence to individualize the treatment of carotid stenosis in this challenging population.

Evidence-Based Carotid Interventions for Stroke Prevention: State-of-the-art Review.

Carotid artery stenosis is responsible for between 10–20% of all ischaemic strokes. Interventions, such as carotid end-arterectomy and carotid stenting, effectively reduce the risk of stroke in selected individuals. This review describes the history of carotid interventions, and summarises reliable evidence on the safety and efficacy of these interventions gained from large randomised clinical trials.Early trials comparing carotid endarterectomy to medical therapy alone in symptomatic patients, and asymptomatic patients, demonstrated that endarterectomy halved the risk of stroke and perioperative death in these two unique populations. The absolute risk reduction was smaller in the asymptomatic carotid trials, consistent with their lower absolute stroke risk. More recent trials in symptomatic patients, suggest that carotid stenting has similar long term durability to carotid endarterectomy, but possibly has higher procedural hazards dominated by non-disabling strokes. The Asymptomatic Carotid Surgery Trial-2, along with individual patient data meta-analysis of all asymptomatic trials, will provide reliable evidence for the choice of intervention in asymptomatic patients in whom a decision has been made for carotid revascularisation. Given improvements in effective cardiovascular medical therapy, in particular lipid-lowering medications, there is renewed uncertainty as to whether carotid interventions still provide meaningful net reductions in stroke risk in asymptomatic populations. Four large trials in Europe and the US are currently underway, and are expected to report longterm results in the next decade.It is essential that surgeons, interventionalists, and physicians continue to randomise large numbers of patients from around the world to clarify current uncertainty around the management of asymptomatic carotid stenosis.

Optimal treatment of extracranial carotid artery disease: carotid endarterectomy, carotid stenting, or optimal medical therapy.

The optimal treatment of extracranial carotid artery disease is more controversial for asymptomatic than for symptomatic patients. Early trials comparing carotid endarterectomy to medical therapy alone demonstrated clear benefit of surgery in both symptomatic and asymptomatic populations. However, some believe that advances in medical therapy now lead to similar outcomes with optimal medical therapy alone and revascularization in asymptomatic patients. The role of carotid stenting is heavily debated, and the evidence base comparing carotid stenting to endarterectomy is limited primarily by inadequate operator experience as well as paucity of data in high surgical risk patients. A useful clinical approach to carotid bifurcation disease is to categorize patients by symptomatic status and revascularization risk. For symptomatic patients, revascularization should be favored over medical therapy alone. For asymptomatic patients, medical therapy alone might be considered, particularly for patients at high risk of revascularization and with anticipated survival <3-5years.

Characteristics that define high risk in carotid endarterectomy from the Vascular Study Group of New England

The Stenting with Angioplasty and Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial compared carotid endarterectomy (CEA) to carotid artery stenting (CAS) among high-risk patients using a model of risk that has not been validated by previous publications. The objective of our study was to determine the accuracy of this high-risk model and to determine the true risk factors that result in patients being at high risk for CEA. Prospectively collected data for 3098 CEAs between 2003 and 2011 at 20 Vascular Surgery Group of New England (VSGNE) centers were used. SAPPHIRE general inclusion criteria and primary outcomes were assessed. Factors that were associated with the primary outcome by analysis of variance (P < .10) and not linearly dependent, as determined by a Pearson correlation analysis, were further assessed for an independent association by multivariate logistic regression. A risk index model was developed for these significant predictors to accurately define high-risk CEA. The average patient age was 69.9 ± 9.5 years, 60% were male, and 45.7% were asymptomatic. The 1-year composite outcome event rate, defined as postoperative myocardial infarction and stroke or death, was 14.2%. Multivariate analysis (P < .05) found the following independently significant risk factors: age in years (95% confidence interval [CI], 1.0-1.1; P < .001), preadmission living in a nursing home (95% CI, 1.2-6.6; P = .020), congestive heart failure (95% CI, 1.4-2.8; P < .001), diabetes mellitus (DM; 95% CI, 1.1-1.3; P < .001), chronic obstructive pulmonary disease (95% CI, 1.2-1.5; P < .001), any previous cerebrovascular disease (95% CI, 1.1-1.9; P = .003), and contralateral internal carotid artery stenosis (95% CI, 1.0-1.2; P = .001). Three of the SAPPHIRE high-risk criteria-abnormal stress test, recurrent stenosis after CEA, and previous radiotherapy to the neck-were not independently associated with an adverse outcome. Independently significant risk factors not included in the SAPPHIRE criteria are inclusion of ages <80 years, preadmission living in a nursing home, DM, contralateral carotid stenosis, and any previous cerebrovascular accident. The risk index predictors are age in years (40-49: 0 points; 50-59: 2 points; 60-69: 4 points; 70-79: 6 points; 80-89: 8 points), living in a nursing home (4 points), any cardiovascular disease (2 points), congestive heart failure (5 points), chronic obstructive pulmonary disease (3 points), DM (2 points), degree of contralateral stenosis (<50%: 0 points; 50%-69%: 1 point; 70%-near occlusion: 2 points; occlusion: 3 points). High-risk CEA is defined as >13 points, representing adverse outcome rate of 22.5%. SAPPHIRE and other previously reported high-risk CAS inclusion criteria do not include all of the factors found to be independently associated with outcomes. Further studies are required to determine whether CAS is inferior to CEA in high-risk patients using a validated model of risk. In addition, this preoperative assessment includes novel criteria that can be used to stratify risks.

Uloga postojanja baze podataka u istraživanju pacijenata obolelih od karotidne ateroskleroze na koje se ne može primeniti hirurško i endovaskularno lečenje

Randomized Controlled Trials (RCT) comparing carotid endarterectomy (CEA) and carotid angioplasty and stenting (CAS) provide the key data in appropriate treatment of carotid atherosclerosis. Still further survey of patients' not meeting inclusion criteria or patients' unsuitable for randomization is not mentioned during the follow up and thus seriously impairing the message these trials are sending to the world medical community. The answer to this question can be obtained from specially created carotid databases (CDB) that include all patients diagnosed and treated for carotid atherosclerosis. Besides preoperative characteristics, CDB includes all the details regarding diagnostic (ultrasound, CT angiography) and interventional (CEA or CAS) procedures in each included patient. In addition to this valuable material, CDB provides very important information about the patients during the follow-up and especially the patients who were not treated by any interventional procedure (CEA or CAS). The results of further treatment and follow up of patients' unsuitable for the CEA or CAS are needed to give 'real-world' answer which of the two procedures is superior to another in the treatment of carotid atherosclerosis. Specially created carotid databases could give the answers to this specific question.

Gender and Outcomes of Carotid Artery Interventions

The benefits of carotid artery revascularization in women have been debated since the publication of large randomized clinical trials comparing carotid endarterectomy (CEA) to medical therapy. Institutional series have historically had an underrepresentation of women and/or have lacked power for adequate analysis. Recent evidence from large databases reveals possible gender-based differences in outcomes of carotid artery stenting versus CEA. In this review, we evaluated clinical articles from 1991 to 2012, using Pubmed and Web of Science, which addressed gender and outcomes of carotid artery revascularization procedures. Our goal was to determine whether gender is associated with adverse outcomes following carotid artery interventions in patients with carotid artery disease.

Carotid Revascularization in Elders: Which Method Is Preferred?

Several clinical trials have been conducted in North America and Europe comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS) in patients with symptomatic carotid stenosis. One trial (CREST) also included asymptomatic patients. These authors performed a meta-analysis of published carotid stenosis treatment studies that reported age-specific data, focusing on the outcomes of these procedures in elders. They identified 44 studies that involved 512,685 …