Differences in Perioperative Outcomes after Carotid Revascularization between White and Non-white Patients.

BACKGROUND: Racial disparities in carotid endarterectomy (CEA) and carotid artery stenting (CAS) continue to persist. We aimed to provide a large-scale analysis of racial disparities in perioperative outcomes of carotid revascularization in a nationally representative cohort of patients, with sub-analyses stratifying by procedure type and symptomatic status. METHODS: We studied all patients undergoing carotid revascularization between 2011 and 2018 in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) Database. Univariate methods were used to compare patients' demographic and medical characteristics. Multivariable logistic regression analysis was used to compare adjusted perioperative outcomes between white patients (WP) and non-white patients (NWP). Sub-analysis was performed stratifying by method of revascularization and symptomatic status. RESULTS: A total of 31,356 carotid revascularizations were performed in 26,550 (84.7%) white patients and 4,806 (15.3%) non-white patients. On adjusted analysis, NWP had increased odds of stroke (OR:1.2, 95%CI:1.1-1.5, P = 0.0496), unplanned return to the OR (OR:1.4, 95%CI:1.1-1.6, P < 0.001) and restenosis (OR:2.6, 95%CI:1.7-3.9, P < 0.001). On sub-analysis, NWP undergoing CAS had increased odds of stroke/death (OR:2.2, 95%CI:1.1-4.3, P = 0.025), stroke (OR:2.9, 95%CI:1.3-6.0, P = 0.007), and stroke/TIA (OR:2.1, 95%CI:1.0-4.2, P = 0.025). NWP undergoing CEA had increased odds of unplanned return to the OR (OR:1.4, 95%CI:1.2-1.6, P < 0.001) and restenosis (OR:2.7, 95%CI:1.7-4.0, P < 0.001). CONCLUSION: NWP had higher rates of 30-day stroke, driven primarily by higher rates of perioperative stroke/death in NWP undergoing CAS. NWP undergoing CEA did not have higher rates of stroke/death after adjusted analysis, although they had higher rates of unplanned return to OR and restenosis. Upon stratification for symptomatic status, the stroke/death rate between NWP and WP was shown to be non-significant.

Epidemiological Analysis of 37,424 Carotid Artery Stenosis Intervention Procedures During 11 Years in the Public Health System in Brazil: Stenting has Been More Common Than Endarterectomy.

BACKGROUND: Stroke is a leading cause of death worldwide, with carotid atherosclerosis accounting for 10-20% of cases. In Brazil, the Public Health System provides care for roughly two-thirds of the population. No studies, however, have analysed large-scale results of carotid bifurcation surgery in Brazil. METHODS: This study aimed to describe rates of carotid artery stenting (CAS) and carotid endarterectomy (CEA) performed between 2008 and 2019 in the country through web scraping of publicly available databases. RESULTS: Between 2008 and 2019, 37,424 carotid bifurcation revascularization procedures were performed, of which 22,578 were CAS (60.34%) and 14,846 (39.66%) were CEA. There were 620 in-hospital deaths (1.66%), 336 after CAS (1.48%) and 284 after CEA (1.92%) (P = 0.032). Governmental reimbursement was US$ 77,216,298.85 (79.31% of all reimbursement) for CAS procedures and US$ 20,143,009.63 (20.69%) for CEA procedures. The average cost per procedure for CAS (US$ 3,062.98) was higher than that for CEA (US$ 1,430.33) (P = 0.008). CONCLUSIONS: In Brazil, the frequency of CAS largely surpassed that of CEA. In-hospital mortality rates of CAS were significantly lower than those of CEA, although both had mortality rates within the acceptable rates as dictated by literature. The cost of CAS, however, was significantly higher. This is a pioneering analysis of carotid artery disease management in Brazil that provides, for the first time, preliminary insight into the fact that the low adoption of CEA in the country is in opposition to countries where utilization rates are higher for CEA than for CAS.

Cost-effectiveness of transcarotid artery revascularization versus carotid endarterectomy.

OBJECTIVE: Recent studies have demonstrated that transcarotid artery revascularization (TCAR) has comparable outcomes to the surgical gold standard, carotid endarterectomy (CEA). However, few studies have analyzed the cost of TCAR, and no study has evaluated its cost-effectiveness. The purpose of this study is to conduct a cost-effectiveness analysis comparing TCAR with CEA for carotid artery stenosis. METHODS: We built a Markov microsimulation using transition probabilities and utilities from existing literature for symptomatic patients undergoing TCAR or CEA. Costs were derived from literature then converted to 2019 dollars. The model included six health states with monthly cycle lengths: surgery, death, alive after surgery, alive after myocardial infarction, alive after stroke, and alive after stroke and death. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) were analyzed over a 5-year period. One-way sensitivity and probabilistic sensitivity analyses were conducted to study the impact of parameter variability on cost effectiveness. RESULTS: For symptomatic patients, CEA cost $7821 for 2.85 QALYs, whereas TCAR cost $19154 for 2.92 QALYs, leading to an ICER of $152,229 per QALY gained in the TCAR arm. Sensitivity analysis demonstrated that our model was most sensitive to probability of restenosis, costs of TCAR, and costs of CEA. Probabilistic sensitivity analysis demonstrated TCAR would be considered cost-effective in 49% of iterations. CONCLUSIONS: This study found that, although 5-year costs for TCAR were greater than CEA, TCAR afforded greater QALYs than CEA. TCAR became cost-effective at 6 years of follow-up.

Could Gender Impact on Immediate and Long-term Carotid Artery Stenting Outcome? Insight from an Italian Single Center Experience.

BACKGROUND: Carotid artery stenting (CAS) has become a valid alternative to carotid endarterectomy in stroke prevention. However, female gender is still considered as an independent risk factor for CAS procedures, potentially limiting immediate and long-term benefits. Aim of present study was to evaluate gender differences in CAS submitted patients from an Italian high-volume center. MATERIAL AND METHODS: a retrospective monocentric study has been conducted on 568 patients (366 males and 202 females), submitted to CAS, between January 2000 and December 2019. Besides gender sex, clinical anatomical, and procedural data were collected as possible factors determining the outcome, when associated to sex gender itself. Primary endpoint of this study consisted in evaluating the technical and procedural success ratio, and the incidence of major and minor stroke, transient ischemic attack, acute myocardial infarction (AMI) peri-procedurally and at medium and long term, between the male and the female population. Secondary endpoint of this study consisted in evaluating the percentage ratio of minor complications happening peri-procedurally in both genders. RESULTS: Male patients were more likely to be octogenarians, clinical history of coronary artery disease, and smokers, while diabetes was more frequent in female patients. Anatomical and plaque morphology features were not different between the two groups. Technical success was obtained in all but two patients (99,6%), while procedural success was 95% (538/566 patients). During the peri-procedural time, no major stroke, 16 minor strokes (2,81%, 2,45% males vs. 3,45% females, P= 0,48), and 11 transient ischemic attack (2,18% males vs. 1,48% females, P= 0,56) were recorded. At a medium follow-up 57 months, 32 stroke (8 major strokes, 24 minor strokes) episodes (5,6%, males 5,7% vs. females 5,4%, P= 0,88), 24 AMIs (4,2%, males 4,6% vs. females 3,46%, P= 0,5;), 13 restenosis (2,8%, males 2,4% vs. females 1,9%, P= 0,71) and 223 deaths (39,2%, males 34,9% vs. females 47%, P= 0,0048) were noted. CONCLUSIONS: Our results showed no differences in immediate, and long-term CAS outcomes between gender. Larger, prospective studies are required to assess the real importance and significance of gender in determining CAS procedures' benefit and outcome.

Editor's Choice - Risk of Stroke before Revascularisation in Patients with Symptomatic Carotid Stenosis: A Pooled Analysis of Randomised Controlled Trials.

OBJECTIVE: Current guidelines recommending rapid revascularisation of symptomatic carotid stenosis are largely based on data from clinical trials performed at a time when best medical therapy was potentially less effective than today. The risk of stroke and its predictors among patients with symptomatic carotid stenosis awaiting revascularisation in recent randomised controlled trials (RCTs) and in medical arms of earlier RCTs was assessed. METHODS: The pooled data of individual patients with symptomatic carotid stenosis randomised to stenting (CAS) or endarterectomy (CEA) in four recent RCTs, and of patients randomised to medical therapy in three earlier RCTs comparing CEA vs. medical therapy, were compared. The primary outcome event was any stroke occurring between randomisation and treatment by CAS or CEA, or within 120 days after randomisation. RESULTS: A total of 4 754 patients from recent trials and 1 227 from earlier trials were included. In recent trials, patients were randomised a median of 18 (IQR 7, 50) days after the qualifying event (QE). Twenty-three suffered a stroke while waiting for revascularisation (cumulative 120 day risk 1.97%, 95% confidence interval [CI] 0.75 - 3.17). Shorter time from QE until randomisation increased stroke risk after randomisation (χ2 = 6.58, p = .011). Sixty-one patients had a stroke within 120 days of randomisation in the medical arms of earlier trials (cumulative risk 5%, 95% CI 3.8 - 6.2). Stroke risk was lower in recent than earlier trials when adjusted for time between QE and randomisation, age, severity of QE, and degree of carotid stenosis (HR 0.47, 95% CI 0.25 - 0.88, p = .019). CONCLUSION: Patients with symptomatic carotid stenosis enrolled in recent large RCTs had a lower risk of stroke after randomisation than historical controls. The added benefit of carotid revascularisation to modern medical care needs to be revisited in future studies. Until then, adhering to current recommendations for early revascularisation of patients with symptomatic carotid stenosis considered to require invasive treatment is advisable.

Hospital-Level Medicaid Prevalence Is Associated with Increased Length of Stay after Asymptomatic Carotid Endarterectomy and Stenting Despite no Increase in Major Complications.

BACKGROUND: Length of stay (LOS) after carotid endarterectomy (CEA) and carotid artery stenting (CAS) for asymptomatic disease is used as a quality measure and affects hospital operating margins. Patient-level Medicaid status has traditionally been associated with longer hospital LOS. Our goal was to assess the association between hospital-level Medicaid prevalence and postoperative LOS after CEA and CAS. METHODS: The National Inpatient Sample was queried from 2006-2014 for CEA and CAS performed for asymptomatic carotid stenosis. Overall hospital-level Medicaid prevalence was divided into quartiles. The quartiles were further categorized into low Medicaid prevalence (LM) (lowest quartile), medium Medicaid prevalence (MM) (second and third quartiles), and high Medicaid prevalence (HM) (fourth quartile) cohorts. The primary outcome evaluated was postoperative LOS >1 day. The secondary outcomes included perioperative/in-hospital complications and mortality. RESULTS: There were 984,283 patients with asymptomatic carotid stenosis who underwent CEA (88%) or CAS (12%). Mean postoperative LOS after CEA at hospitals with LM, MM, and HM prevalence was 1.4 ± 1.5, 2.1 ± 2.5, and 2.2 ± 2.8 days (P = 0.0001), respectively, and after CAS were 1.7 ± 2.6, 1.8 ± 2.1, and 2 ± 2.6 days (P < 0.0001), respectively. After CEA, relative to LM prevalence, MM (OR 1.62, 95% CI 1.17-2.24) and HM (OR 1.66, 95% CI 1.2-2.28) prevalence were associated with a higher likelihood of LOS > 1 day (P = 0.009). After CAS, relative to LM prevalence, HM prevalence was associated with a higher likelihood of LOS >1 day (OR 1.42, 95% CI 1.06-1.91) (P = 0.003). After CEA, neurologic (0.8% vs. 0.9% vs. 0.9%, P = 0.83) and cardiac complications (0.9% vs. 1.2% vs. 1.2%, P = 0.24) were similar among hospitals with LM, MM, and HM prevalence, respectively. After CAS, the prevalence of neurological (1.1% vs. 1% vs. 1.2%, P = 0.42) and cardiac complications (2% vs. 1.3% vs. 1.5%, P = 0.46) were also similar. After both CEA and CAS, mortality was similar among Medicaid prevalence cohorts. CONCLUSIONS: Higher hospital-level Medicaid prevalence was associated with longer LOS after CEA and CAS for asymptomatic carotid stenosis. Value-based payment models should adjust for hospital-level Medicaid prevalence to appropriately reimburse providers and hospital with higher Medicaid prevalence as well as investigate care pathways and systems improvement to help reduce LOS.

Contemporary Trends in Physician Utilization Rates of CEA and CAS for Asymptomatic Carotid Stenosis among Medicare Beneficiaries.

BACKGROUND: Carotid revascularization for asymptomatic carotid artery stenosis (ACAS) has become increasingly controversial in the past few decades as the best medical therapy has improved. The aim of this study was to assess and define contemporary trends in the rate of carotid revascularization procedures for ACAS in the United States and to characterize outlier physicians performing a higher rate of asymptomatic revascularization compared to their peers. METHODS: We used 100% Medicare fee-for-service claims to identify all patients who were newly diagnosed with ACAS between 01/2011-06/2018. Patients with symptomatic carotid artery stenosis, those with prior carotid revascularization, and surgeons who performed ≤10 CEAs during the study period were excluded. We used a hierarchical multivariable logistic regression model to evaluate patient and physician characteristics associated with undergoing a carotid endarterectomy or carotid artery stent procedure within 3 months after the initial diagnosis of ACAS. We also assessed temporal trends in carotid revascularization rates over time using the Cochran-Armitage Trend Test. RESULTS: Overall, 795,512 patients (median age 73.9 years, 50.9% male, 87.6% white) had a first-time diagnosis of ACAS during the study period, of which 23,481 (3.0%) underwent carotid revascularization within 3 months. There was a significant decline in overall carotid artery revascularization rates over time (2011: 3.2% vs. 2018: 2.1%; P < 0.001). The median and mean physician-specific carotid revascularization rates were 2.0% (IQR 0.0%-6.3%) and 4.7% ± 7.1%, respectively. Three-hundred and fifty physicians (5.2%) had carotid revascularization rates ≥19%, which was more than 2 standard deviations above the mean. After adjusting for patient-level characteristics, physician-level variables associated with carotid revascularization for newly diagnosed ACAS included male sex (adjusted OR 1.59, 95% CI 1.35-1.89), more years in practice (≥31 vs. <10 years, aOR 1.64, 95% CI 1.32-2.04), rural practice location (aOR 1.34, 95% CI 1.18-1.52), Southern region practice location (versus Northeast, aOR 1.54, 95% CI 1.39-1.69), and lower volume of ACAS patients (lower versus upper tertile, aOR 2.62, 95% CI 2.39-2.89). Cardiothoracic surgeons had a 1.52-fold higher odds of carotid revascularization compared to vascular surgeons (95% CI 1.36-1.68), whereas cardiologists and radiologists had lower intervention rates (both, P < 0.05). CONCLUSIONS: The current early revascularization rate for newly diagnosed ACAS is <5% among proceduralists in the United States, and has been decreasing steadily since 2014. There are particular physician-level characteristics that are associated with higher rates of carotid revascularization that cannot be fully contextualized without high-level contemporary outcomes data to guide decision making in ACAS.

Conventional Angiography in the Assessment of Recently Symptomatic Patients with Ipsilateral Carotid Stenosis.

BACKGROUND AND PURPOSE: Benefits of revascularization for moderate and severe (≥50%) carotid stenosis were established based on digital subtraction angiography (DSA). We aimed to assess the discrepancy between invasive and non-invasive angiography in a consecutive, prospective cohort of patients with recent stroke and non-invasive imaging suggesting ≥50% ipsilateral carotid stenosis. MATERIALS AND METHODS: We reviewed prospectively-collected data for consecutive patients admitted with recent stroke/TIA and ≥50% ipsilateral carotid stenosis on non-invasive imaging over 28 months. All patients underwent DSA to confirm the degree of stenosis per NASCET criteria. All patients with <50% stenosis by DSA were treated with medical therapy only and their recurrent event rates were assessed at 6 months. RESULTS: 148 symptomatic patients with ≥50% ipsilateral carotid stenosis on CTA (82%) and MRA (18%) underwent DSA to confirm degree of stenosis. Median age was 73 years and 64% were male. DSA demonstrated <50% stenosis in 28 patients (19%). Median presenting NIHSS was 1 (IQR 0-3). Median carotid stenosis evaluated by non-invasive imaging was 70% (IQR 60-85%) and by DSA was 40% (IQR 30-45%). One of 28 patients (4%) experienced recurrent nondisabling stroke (NIHSS 1) after stopping dual antiplatelet therapy. CONCLUSION: In nearly one-in-five cases with recent stroke due to ipsilateral carotid stenosis deemed to be candidates for revascularization based on CTA or MRA, DSA led to institution of medical therapy only due to insufficiently severe stenosis. In patients treated with medical therapy based on the findings of <50% stenosis on DSA, the rate of recurrent stroke is low.

Epidemiological Analysis of Carotid Artery Stenosis Intervention during 10 years in the Public Health System in the Largest City in Brazil: Stenting Has Been More Common than Endarterectomy.

BACKGROUND: Stroke is the second leading cause of death worldwide with approximately 5.7 million cases/year, and carotid atherosclerosis accounts for 10 to 20% of cases. METHODS: In Brazil, the Unified Health System (Sistema Único de Saúde [SUS]) is a tax-funded public health care system that provides care for roughly half the population. São Paulo is the eighth largest city in the world with an estimated population of over 12 million people, of whom more than 5 million rely solely on SUS. This study aimed to describe rates of carotid artery stenting (CAS) and carotid endarterectomy (CEA) performed between 2008 and 2017 in the city of São Paulo through web scraping of publicly available databases. RESULTS: Three thousand seven hundred and four carotid revascularization procedures were performed between 2008 and 2017, of which 2,432 were CAS (65.7%). Rates of CAS ranged from 59.9% in 2016 to 86% in 2011. There were 57 in-hospital deaths (1.54%), 34 after CAS (1.4%; 34/2,432) and 23 after CEA (1.81%; 23/1,272) (P = 0.562). SUS reimbursements were US $7,862,017.09 (81.44% of all reimbursements) for 2,432 CAS procedures and US $1,792,324.06 (18.56%) for 1,272 CEA procedures. Average SUS reimbursement for CAS (US $3,232.73) was more than double than that for CEA (US $1,409.05). CONCLUSIONS: In a city whose population exceeds that of some European countries, costs of CAS and CEA to the public health care system totaled more than US$ 9 million over 10 years. Epidemiologically, CAS was performed more commonly than CEA with no difference in in-hospital mortality between CAS and CEA, but reimbursements were 2.29 times higher for CAS. The low adoption of CEA in São Paulo is in contrast to countries where utilization rates are higher for CEA than for CAS.

Added assessment of middle cerebral artery and atrial fibrillation to FLAIR vascular hyperintensity-DWI mismatch would improve the outcome prediction of acute infarction in patients with acute internal carotid artery occlusion.

BACKGROUND AND AIMS: Whether fluid-attenuated inversion recovery (FLAIR) vascular hyperintensities (FVH)-DWI mismatch could predict the outcome or not remains in debate. The aim of this study was to identify if FVH combined with the other markers improved favorable outcome prediction of acute infarctions in patients with unilateral acute internal carotid artery (ICA) occlusion. METHODS: Consecutive 68 adult acute middle cerebral artery (MCA) territory infarction patients caused by acute ICA occlusion, including favorable (n = 38, mRS ≤ 2) and unfavorable (n = 30, mRS > 2) groups, were enrolled in this retrospective analysis. The diagnostic efficiency of favorable clinical outcome of FVH-DWI mismatch was compared with those of DWI lesions volumetry and the combined marker of FVH-DWI mismatch and other factors. RESULTS: There were more prominent FVH-DWI mismatch (≥ 3 sections) (84%), less atrial fibrillation (AFib) (13%), and more tandem MCA normal or mild stenosis (63%) in favorable outcome group than those (30%, 40%, and 27%, respectively) in unfavorable group. Univariate and multivariate analyses showed that the prominent FVH-DWI mismatch was the positive predictive factor for favorable outcome (OR = 2.643 and 3.200). Prominent FVH-DWI mismatch, in combination with tandem MCA normal or mild stenosis, and absence of Afib, had better performance (AUC = 0.875) than that of initial DWI lesion volumetry (AUC = 0.854) and any other single factor (AUC = 0.634~0.820) in predicting favorable outcome. CONCLUSIONS: Prominent FVH-DWI mismatch was associated with favorable outcome in acute infarctions in unilateral ICA occlusion patients. Its predictive performance would be improved when combined with the assessment of tandem lesions of MCA and AFib.

Assessment of long-term survival and stroke after carotid endarterectomy and carotid stenting in patients older than 80 years.

OBJECTIVE: The objective of this study was to analyze preoperative risk factors affecting long-term survival and the occurrence of stroke in patients older than 80 years undergoing either carotid endarterectomy (CEA) or carotid artery stenting (CAS) for carotid stenosis. METHODS: Data of all consecutive patients treated from January 1999 to December 2017 were retrospectively reviewed and outcomes analyzed. Kaplan-Meier analysis was used to estimate long-term survival and the risk of stroke for both groups. Cox proportional hazards analysis was used to assess the relative risk of all-cause mortality and long-term stroke for patients in the presence of selected comorbidities, including preoperative symptoms, coronary artery disease, chronic renal failure, atrial fibrillation (AF), hypertension, diabetes mellitus, and dyslipidemia. A P value <.05 was considered statistically significant. RESULTS: A total of 473 patients older than 80 years (298 men [63%]) underwent either CEA (n = 178) or CAS. At 30 days, one patient died in the CEA group of unrelated causes; no deaths were recorded after CAS (0.6% vs 0%; P = .18). At 5 years, survival was 67.6% ± 4.9% after CEA and 90.2% ± 2.3% after CAS (P < .0001). The main cause of death after CEA and CAS was a neoplasm. Estimated freedom from any stroke at 5 years was 97.3% ± 0.5% after CEA and 93.2% ± 1.2% after CAS (P = .07). The presence of preoperative AF significantly affected long-term mortality after CAS (hazard ratio [HR], 1.56; 95% confidence interval [CI], 1.34-1.98; P = .04) as well as being classified as American Society of Anesthesiologists class 3 at evaluation of the preoperative anesthesiology risk. The presence of preoperative AF was the only factor that significantly affected the occurrence of long-term stroke after both CAS (HR, 2.28; 95% CI, 1.86-5.63; P = .001) and CEA (HR, 3.45; 95% CI, 2.29-8.19; P = .005). CONCLUSIONS: Both CEA and CAS showed low 30-day mortality and any-stroke rates in patients older than 80 years. In the long term, survival was significantly better after CAS; however, deaths after CEA and CAS were mainly unrelated to the procedure. No significant differences were recorded in the occurrence of any stroke in the long term. The presence of preoperative AF significantly affected long-term survival after CAS as well as being classified as American Society of Anesthesiologists class 3 at evaluation of the preoperative anesthesiology risk. The presence of preoperative AF also significantly affected long-term risk of stroke after both CAS and CEA.

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

BACKGROUND: 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. OBJECTIVES: 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. DESIGN: Randomised controlled trial comparing CEA with CAS. SETTING: Hospitals in the UK and worldwide, in which carotid procedures are common. PARTICIPANTS: Men and women with severely stenotic atherosclerotic carotid artery disease, with or without previous stroke but with no recent symptoms from the randomised artery. INTERVENTIONS: CEA and CAS. OUTCOMES: (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 COSTS AND OUTCOMES: 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. PROGRESS SO FAR: 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. CONCLUSIONS: Further funding has been secured and recruitment continues, with completion anticipated by the end of 2019. ACST-2 will report initial results in 2021. TRIAL REGISTRATION: Current Controlled Trials ISRCTN21144362. FUNDING: 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].

Optical coherence tomography assessment of newgeneration mesh-covered stents after carotid stenting.

AIMS: The aim of this study was to identify the findings (by optical coherence tomography [OCT]) after carotid artery stenting (CAS) with two different types of new-generation mesh-covered stent. METHODS AND RESULTS: Sixteen consecutive patients undergoing CAS with mesh-covered stents and highdefinition OCT image acquisition were enrolled in the study. Cross-sectional OCT images for the presence of strut malapposition (SM) and plaque prolapse (PP) were evaluated using a proximal or distal embolic protection device (EPD). CGuard stents were used in 11 patients (68.8%) and RoadSaver stents in five (31.2%). With OCT analysis, the incidence of SM was 20.5% for CGuard vs. 26.8% for RoadSaver, p=0.26, and the incidence of PP was 10.8% for CGuard vs. 20.7% for RoadSaver, p=0.05. No neurological complications (stroke/TIA) occurred during the procedural and post-procedural periods. CONCLUSIONS: The OCT findings of two different types of mesh-covered stent after CAS were obtained safely. Our work indicates that current mesh-covered carotid stents may show differences in SM and PP. The effect of stent design and implantation technique on OCT findings post CAS, and their relation to longterm clinical outcomes, require further evaluation.

Investigation into drivers of cost of stenting for carotid stenosis.

OBJECTIVE: We aimed to identify factors associated with cost of carotid artery stenting (CAS). METHODS: Patient and hospital characteristics affecting cost of admission for CAS were identified using the Vizient national database of hospital-reported outcomes. Patients who underwent CAS for either asymptomatic or symptomatic carotid stenosis were identified using surgical Medicare Severity-Diagnosis Related Groups and appropriate International Classification of Diseases, Ninth Revision and Tenth Revision codes. RESULTS: There were 166 hospitals that reported outcomes from 7369 inpatient admissions for CAS. Each institution reported a mean value for cost related to patient care per admission for CAS; the average cost across all reporting institutions was $12,834.14 (standard error of the mean [SEM], 492.88). Institutions in the lowest 25th percentile with respect to frequency of intensive care unit admission after CAS had lower cost of admission than institutions above the 75th percentile ($10,971.30 [SEM, 460.67] vs $14,992.90 [964.29]; P = .002), without any differences in incidence of stroke during admission (2.2% [SEM, 0.3] vs 2.0% [0.4]; P = .877) or 30-day readmission (1.9% [SEM, 0.4] vs 2.5 [0.6]; P = .329). Admissions for patients with symptomatic stenosis were more expensive than those with asymptomatic stenosis ($20,462.10 [SEM, 819.93] vs $11,285.20 [347.11]; P < .001). Obesity was also associated with greater costs of admission ($14,176.20 [SEM, 597.13] vs $12,287.10 [395.73]; P < .001). CONCLUSIONS: Admission to an intensive care unit, symptomatic stenosis, and obesity were associated with increased costs in patients undergoing CAS. These data may aid in identifying opportunities to improve the cost-effectiveness of this procedure.

Carotid occlusion is associated with more frequent neurovascular events than moderately severe carotid stenosis.

OBJECTIVE: Asymptomatic internal carotid artery occlusion (CO) presents a clinical dilemma, and presently, the natural history, stroke risk, and optimal management remain ill defined. This study compared outcomes, including neurovascular events (NVEs) and health care costs, between patients with CO and patients with asymptomatic carotid artery stenosis (CS). METHODS: A prospectively maintained database was queried to identify patients with CO and CS with at least >50% carotid stenosis by duplex. We identified and reviewed 622 consecutive patients with asymptomatic carotid artery disease at one academic medical center between 2011 and 2013. Patients with CO (n = 97) were identified and propensity matched by age and gender in a 1:2 ratio with CS patients (n = 194) for further analyses. Univariate and multivariate models were used to analyze baseline characteristics, clinical variables, and 1-year follow-up data from the date of diagnosis. Multivariate analysis was performed by multiple linear regression modeling. Institutional Review Board approval was obtained. RESULTS: Follow-up data were available for 99% of matched patients. CO patients were younger (72 vs 75 years; P < .01) and more likely male (67% vs 53%; P = .01) compared with CS patients. After propensity matching, baseline characteristics were similar between groups, with a trend toward higher use of statin therapy among patients with CO. Antiplatelet therapy was used in 79% of patients with CS and in 74% of patients with CO (P = .45). The rate of NVE among CO patients was higher than among CS patients at 1 year of follow-up (14% vs 7%; P = .03). Among those with NVE, neither antiplatelet therapy (64% vs 77%; P = .49) nor statin therapy (86% vs 77%; P = .58) appeared to have a significant effect. Health care costs ($14,361 vs $12,142; P = .44) and hospital admission rate (63% vs 71%; P = .18) were similar between groups. Not surprisingly, the rate of vascular procedures was higher in the CS group (55% vs 27%; P = .04). CONCLUSIONS: Patients with asymptomatic CO experience more NVEs compared with similar patients with moderately severe CS. Further study of preventative strategies, including intensity of medical therapy, is warranted.

Editor's Choice - Carotid Stenosis Treatment: Variation in International Practice Patterns.

OBJECTIVES: The aim was to determine current practice for the treatment of carotid stenosis among 12 countries participating in the International Consortium of Vascular Registries (ICVR). METHODS: Data from the United States Vascular Quality Initiative (VQI) and the Vascunet registry collaboration (including 10 registries in Europe and Australasia) were used. Variation in treatment modality of asymptomatic versus symptomatic patients was analysed between countries and among centres within each country. RESULTS: Among 58,607 procedures, octogenarians represented 18% of all patients, ranging from 8% (Hungary) to 22% (New Zealand and Australia). Women represented 36%, ranging from 29% (Switzerland) to 40% (USA). The proportion of carotid artery stenting (CAS) among asymptomatic patients ranged from 0% (Finland) to 26% (Sweden) and among symptomatic patients from 0% (Denmark) to 19% (USA). Variation among centres within countries for CAS was highest in the United States and Australia (from 0% to 80%). The overall proportion of asymptomatic patients was 48%, but varied from 0% (Denmark) to 73% (Italy). There was also substantial centre level variation within each country in the proportion of asymptomatic patients, most pronounced in Australia (0-72%), Hungary (5-55%), and the United States (0-100%). Countries with fee for service reimbursement had higher rates of treatment in asymptomatic patients than countries with population based reimbursement (OR 5.8, 95% CI 4.4-7.7). CONCLUSIONS: Despite evidence about treatment options for carotid artery disease, the proportion of asymptomatic patients, treatment modality, and the proportion of women and octogenarians vary considerably among and within countries. There was a significant association of treating more asymptomatic patients in countries with fee for service reimbursement. The findings reflect the inconsistency of the existing guidelines and a need for cooperation among guideline committees all over the world.

Fixed and variable cost of carotid endarterectomy and stenting in the United States: A comparative study.

OBJECTIVE: Despite multiple landmark clinical trials, little data exists on real-world cost of carotid artery stenting (CAS) and carotid endarterectomy (CEA) to the United States healthcare system. We aim to study differences in actual hospitalization cost between patients who underwent CAS vs CEA in a nationally representative database. METHODS: We studied hospital discharge and billing records of all patients, in the Premier Perspective Database, who underwent CEA or CAS between the third quarter of 2009 and the first quarter of 2015. Nearest-neighbor 1:1 propensity score matching was performed, to account for differences in patient and hospital characteristics as well as clinical comorbidities of patients who underwent both procedures, for both symptomatic and asymptomatic cohorts using 32 variables. Pearson χ2, Student t-test, and nonparametric K-sample equality-of-medians tests were used to analyze the data, as appropriate. The primary outcome was total in-hospital cost, including fixed (administrative, capital and utilities) and variable costs (labor and supply). Cost data were presented as medians, inflation-adjusted for 2015 U.S. dollar and rounded to the nearest dollar. RESULTS: A total of 115,548 procedures were identified. The mean age was 71 and 69 years; 58% and 57% were male patients; and 81% and 77% were white among asymptomatic and symptomatic patients, respectively. After propensity score matching, 25,812 asymptomatic (12,906 CEA and 12,906 CAS) and 3864 symptomatic (1932 CEA and 1932 CAS) patients were included. Total hospitalization cost per CAS was 40% ($11,814 vs $8378; P < .001) and 37% ($19,426 vs $14,190; P < .001) higher than CEA among asymptomatic and symptomatic patients, respectively. Patients who underwent CAS incurred significantly higher total hospitalization cost despite stratifying by type of cost (fixed and variable), U.S. census regions and symptomatic status. Moreover, asymptomatic patients who underwent CAS performed by any surgical specialty incurred an average of $2717 to $4918 higher total hospitalization cost compared with patients who underwent CEA (all P < 001). Among symptomatic patients, those who underwent CAS performed by vascular, cardiac, and neurologic surgeons, incurred $2108 ($16,114 vs $14,006; P = .006), $7055 ($17,351 vs $10,296; P = .023) and $6479 ($27,290 vs $20,811; P = .002) higher total hospitalization cost compared with patients who underwent CEA, respectively. CONCLUSIONS: The total hospitalization cost incurred by patients who underwent CAS was significantly higher than for those who underwent CEA, despite matching cohort based on patient and hospital characteristics, and stratifying by symptomatic status, type of cost, hospital region, and surgeon specialty. Our findings could provide additional important information giving the ongoing controversy regarding the appropriate indication for CAS.

Carotid Stenting Versus Carotid Endarterectomy: What Did the Carotid Revascularization Endarterectomy Versus Stenting Trial Show and Where Do We Go From Here?

Although rapidly expanding in its use, carotid artery stenting remains a relatively new procedure. Its growth is due, at least in part, to the perceived advantages of a less invasive technique. However, the clinical effectiveness and specific role for stenting in the treatment of carotid occlusive disease are still under evaluation. The primary aim of the randomized clinical trial, Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), was to contrast the relative efficacy of carotid stenting versus carotid endarterectomy in preventing stroke, myocardial infarction, or death during a 30-day periprocedural period or ipsilateral stroke over the follow-up period in patients with symptomatic and asymptomatic extracranial carotid stenosis. The secondary goals were to describe the differential efficacy of the 2 procedures in men and women, contrast periprocedural (30-day) morbidity and postprocedural morbidity and mortality, estimate and contrast the restenosis rates of the 2 procedures, evaluate differences in measures of health-related quality of life and cost-effectiveness, and identify subgroups of participants at differential risk of stenting or surgery. This report summarizes the results obtained from CREST with respect to its primary and secondary aims.