Carotid Revascularization Endarterectomy Versus Stenting Research Articles

Repeat Revascularization over 10 Years Following Carotid Endarterectomy or Carotid Stent Placement: An Analysis of Carotid Revascularization Endarterectomy Versus Stenting Trial

To identify rates of and factors associated with repeat revascularization in a large cohort of patients prospectively followed over 10 years in Carotid Revascularization Endarterectomy versus Stenting Trial. We compared the effect of carotid angioplasty and stenting (CAS) versus carotid endarterectomy (CEA) on risk of repeat revascularization after adjusting for age, sex, symptomatic status, and initial severity of stenosis (≥70% vs. <70%) using Cox proportional hazards analysis. We used Kaplan-Meier analysis to assess repeat revascularization-free survival for the overall cohort. Repeat revascularization was performed in 90 (3.9%, 95% confidence interval [CI] 3.1%-4.8%) of 2318 patients; 6 (6.7%, 95% CI 2.5%-14.0%) patients experienced the composite end point of any stroke, myocardial infarction, ordeath within 30 days after repeat revascularization. Therewas no difference in risk of repeat revascularization in patients who underwent CAS (compared with CEA) as theindex procedure (hazard ratio 0.92, 95% CI 0.69-1.23, P=0.5765). Patient's age (hazard ratio 1.01, 95% CI 1.01-1.02, P < 0.0001) was associated with performance of repeat revascularization. Mean ± SD repeat revascularization-free survival was 8.2 ± 0.1 years and 8.0 ± 0.1 years for CAS and CEA, respectively (log-rank test P= 0.0823). A low rate of repeat revascularization was seen without any significant difference among patients who underwent CEA or CAS over 10 years. The 6.7% rate of composite end point within 30 days after procedure highlights the need for standardizing the indications for repeat revascularization.

Absence of Consistent Sex Differences in Outcomes From Symptomatic Carotid Endarterectomy and Stenting Randomized Trials.

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

Nationwide Trends in Carotid Endarterectomy and Carotid Artery Stenting in the Post-CREST Era.

Background and Purpose- The CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) demonstrated equivalent composite outcomes between carotid endarterectomy (CEA) and carotid artery stenting (CAS) for treating carotid stenosis. We investigated nationwide trends in these procedures and associated periprocedural stroke, myocardial infarction, death, cost, and readmission rates since CREST outcomes were published. Methods- We queried the Nationwide Readmissions Database to identify patients undergoing CEA and CAS for asymptomatic and symptomatic carotid stenosis from 2010 to 2015. Patients were matched based on demographics, comorbidities, and severity of illness. Results- In total, 378 354 CEA and 57 273 CAS patients were treated during this 6-year period. CEA volume decreased by an average of 2669 procedures annually (P=0.001) with stable CAS volume (P=0.225). After matching, CEA patients had a higher rate of periprocedural stroke than CAS patients, driven by increased stroke risk in symptomatic CEA patients (8.1% versus 5.6%; odds ratio, 1.47 [CI, 1.29-1.68]; P<0.001) but a lower rate of overall inpatient mortality (0.8% versus 1.4%; odds ratio, 0.57 [CI, 0.48-0.68]; P<0.001). CEA patients were less likely to be readmitted within 30 days (7.2% versus 8.0%; odds ratio, 0.90 [CI, 0.84-0.96]; P=0.018) and 90 days (12.3% versus 14.1%; odds ratio, 0.86 [CI, 0.81-0.90]; P<0.001), and mean hospital costs were lower for CEA compared with CAS ($14 433 versus $19 172; P<0.001). Conclusions- The procedural treatment of carotid stenosis has changed dramatically in the post-CREST era. When matched for characteristics and illness severity, patients undergoing CEA had a higher rate of perioperative stroke than patients undergoing CAS, primarily among symptomatic patients. These findings are in contrast to the findings of CREST, which showed nearly twice the risk of stroke in CAS patients compared with CEA patients. CEA was associated with lower procedure cost and readmission rate.

Association between perioperative stroke and 30-day mortality in carotid endarterectomy: A meta-analysis

ObjectivesPerioperative stroke is a known complication of carotid endarterectomy (CEA) for patients with symptomatic and asymptomatic carotid stenosis. The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) has shown that stroke following CEA is associated with nearly a 3-fold increase in the 4-year mortality compared to patients without such an event. However, no studies to date can establish whether the stroke was the cause of the short term mortality. Thus, our objective is to evaluate if perioperative stroke after CEA increases the risk of 30-day mortality. Patients and MethodsWe performed a meta-analysis of the literature from PubMed and the World Science Database on studies reporting perioperative strokes and 30-day mortality in symptomatic and asymptomatic CEA patients. 3400 articles were retrieved, and abstracts were further screened using the inclusion criteria to obtain a final set of 83 randomized controlled trials and retrospective/prospective studies. ResultsA total of 123,507 CEA procedures were included among the 83 studies. The 30-day perioperative stroke rate for all included studies was 2.15%. The 30-day all-cause mortality rate was 0.93%. In patients with perioperative strokes, the 30-day mortality rate was found to be 17.01%. Among patients without perioperative strokes, the 30-day mortality rate was much lower at 0.57%. The summary odds ratio of perioperative stroke and 30-day mortality was 39.86 (95% CI, 29.30–54.23, p < 0.001). ConclusionPatients with perioperative stroke have an almost 40 times increased risk of 30-day stroke-related mortality. This study highlights the importance of developing a preoperative risk assessment and neuroprotective treatment trial for perioperative stroke.

Sex-Based Differences in Ten-Year Nationwide Outcomes of Carotid Revascularization

We compared the rates of stroke, death, and/or MI between men and women, stratified by symptomatic status and procedure type (carotid endarterectomy [CEA] or carotid artery stent [CAS]). Using the Nationwide Inpatient Sample, crude and propensity-matched rates of the composite end point of stroke/death/MI were estimated. Multivariable logistic regression was used to calculate the odds of stroke/death/MI associated with sex. Between 2005 and 2015, there were 1,242,688 carotid interventions performed (1,083,912 CEA; 158,776 CAS; 515,789 [41.5%] were female patients). Symptomatic admissions comprised 11.3% of the cohort. In-hospital stroke/death/MI rates were more prevalent in men compared with women (4.2% vs 3.9%; p < 0.01). Subgroup analysis revealed symptomatic women vs men had higher rates of stroke after CEA (7.7% vs 6.2%; p < 0.01) and CAS (9.9% vs 7.6%; p < 0.01). Asymptomatic women experienced the same rates of stroke after either CEA (0.3% vs 0.3%; p= 0.051) or CAS (0.4% vs 0.5%; p= 0.09). Propensity-matched logistic regression revealed that symptomatic males vs females had lower odds of stroke after CEA (odds ratio [OR] 0.81; 95% CI 0.72 to 0.91) and CAS (OR 0.72; 95% CI 0.57 to 0.90). Asymptomatic men and women had similar odds of stroke after both CEA (OR 0.95; 95% CI 0.79 to 1.14) and CAS (OR 0.70; 95% CI 0.43 to 1.13). This is the largest cohort study to date that demonstrates asymptomatic women undergoing CEA or CAS do not have a higher risk of perioperative stroke, death, or MI. Symptomatic men experience lower rates of stroke after CEA or CAS.

Prediction Models for Clinical Outcome After a Carotid Revascularization Procedure.

Background and Purpose- Prediction models may help physicians to stratify patients with high and low risk for periprocedural complications or long-term stroke risk after carotid artery stenting or carotid endarterectomy. We aimed to evaluate external performance of previously published prediction models for short- and long-term outcome after carotid revascularization in patients with symptomatic carotid artery stenosis. Methods- From a literature review, we selected all prediction models that used only readily available patient characteristics known before procedure initiation. Follow-up data from 2184 carotid artery stenting and 2261 carotid endarterectomy patients from 4 randomized trials (EVA-3S [Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis], SPACE [Stent-Protected Angioplasty Versus Carotid Endarterectomy], ICSS [International Carotid Stenting Study], and CREST [Carotid Revascularization Endarterectomy Versus Stenting Trial]) were used to validate 23 short-term outcome models to estimate stroke or death risk ≤30 days after the procedure and the original outcome measure for which the model was developed. Additionally, we validated 7 long-term outcome models for the original outcome measure. Predictive performance of the models was assessed with C statistics and calibration plots. Results- Stroke or death ≤30 days after the procedure occurred in 158 (7.2%) patients after carotid artery stenting and in 84 (3.7%) patients after carotid endarterectomy. Most models for short-term outcome after carotid artery stenting (n=4) or carotid endarterectomy (n=19) had poor discriminative performance (C statistics ranging from 0.49-0.64) and poor calibration with small absolute risk differences between the lowest and highest risk groups and overestimation of risk in the highest risk groups. Long-term outcome models (n=7) had a slightly better performance with C statistics ranging from 0.59 to 0.67 and reasonable calibration. Conclusions- Current models did not reliably predict outcome after carotid revascularization in a trial population of patients with symptomatic carotid stenosis. In particular, prediction of short-term outcome seemed to be difficult. Further external validation of existing prediction models or development of new prediction models is needed before such models can be used to support treatment decisions in individual patients.

CREST-2: Identifying the Best Method of Stroke Prevention for Carotid Artery Stenosis: National Institute of Neurological Disorders and Stroke Organizational Update.

One of the great achievements of modern medicine is the successful prevention of stroke and other cardiovascular diseases. Although the incidence of stroke has substantially declined over the last 30 years, ≈200 000 preventable stroke deaths still occur annually in the United States. According to a recent study based on the Greater Cincinnati/Northern Kentucky Stroke Study, annually ≈41 000 strokes in the United States are attributed to extracranial internal carotid artery stenosis. Early revascularization for symptomatic carotid stenosis—that is, in patients with recent ipsilateral stroke or TIA—is well established as effective at preventing ipsilateral stroke. Carotid stenosis in the absence of symptoms is extremely common, but the best treatment is unclear. While 2 randomized trials showed a benefit of carotid endarterectomy (CEA) over antiplatelet therapy with aspirin, the number needed to treat approaches 200. Does aggressive risk factor control change that balance? Population screening for carotid stenosis followed by revascularization is considered to cause net harm. Are complication rates from endarterectomy and stenting now low enough to justify expanding their indications in asymptomatic patients? The National Institute of Neurological Disorders and Stroke (NINDS)–funded CREST-2 trial (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial) is an ambitious attempt to further refine the treatment of asymptomatic carotid stenosis. As one of the largest randomized stroke prevention trials, the first CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) was designed to compare the safety and efficacy of 2 stroke prevention procedures for carotid artery narrowing—CEA and carotid artery stenting (CAS)—in symptomatic and asymptomatic individuals. Starting in December 2000, this NINDS-funded trial enrolled >2500 patients at 117 sites in the United States and Canada. Because of slow enrollment, the trial took 9 years to complete. In 2010, the results of CREST indicated that the 2 revascularization procedures were equivalent for …

Which patients with asymptomatic carotid stenosis benefit from revascularization?

To summarize why there are polarized opinions regarding the management of patients with asymptomatic carotid disease and whether it is possible to identify patients who might benefit from carotid interventions. Carotid Revascularization Endarterectomy Versus Stenting Trial and Asymptomatic Carotid Trial 1 (ACT-1) recently concluded that outcomes after carotid endarterectomy and carotid stenting were not significantly different in asymptomatic patients and that procedural risks were below the accepted 3% threshold. However, systematic reviews suggest that Carotid Revascularization Endarterectomy Versus Stenting Trial/ACT-1 results may not be generalizable into routine practice. In parallel, meta-analyses suggest that stroke rates on medical therapy may be declining, suggesting that Asymptomatic Carotid Atherosclerosis Study/Asymptomatic Carotid Surgery Trial data, which have underpinned every practice guideline since 1995, are too historical for use in 2017. A recent review has, however, identified a number of clinical/imaging features that may be associated with higher rates of stroke on medical therapy. The majority of surgeons/interventionists are unlikely to accept radical changes in practice until new randomized trials confirm that the risk of stroke on modern medical therapy is significantly lower than that previously accepted. In the interim, it would be preferable to target interventions into a smaller cohort who present with clinical/imaging features that might render them 'higher risk for stroke' on medical therapy.

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.

Asymptomatic carotid artery disease – What is the evidence for intervention?

Strong evidence exists in favor of revascularization in symptomatic carotid artery stenosis. Contrarily, no unified consensus exits on the best management strategy in asymptomatic carotid artery disease. Early trials on carotid revascularization in asymptomatic stenosis suggested an absolute benefit in favor of intervention. However, with the advent in aggressive medical therapy, rate of stroke/TIA in the territory of asymptomatic stenosis is small and has dropped to approximately 1% per annum. Similarly, complication rate with carotid revascularization has reduced with gain in operator experience. This is evident from the lead-in phase analysis of the Carotid Revascularization Endarterectomy Versus Stenting Trial and the interim results of the asymptomatic carotid surgery (ACST) 2 trial. Therefore, it is crucial to determine the patient group at ‘high’ risk of future stroke on medical therapy. Plaque morphology, collateral status and cerebrovascular reserve, microembolic signals on Transcranial Doppler assessment, history of contralateral stroke/TIA, and severity and progression of stenosis are the key predictors of future stroke risk. We discuss the evidence in support of revascularization in severe ‘high risk’ asymptomatic stenosis based on review of published literature.

Time From Symptoms to Carotid Endarterectomy or Stenting and Perioperative Risk

Prior meta-analysis showed that carotid endarterectomy benefits decline with increasing surgical delay following symptoms. For symptomatic patients in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), we assessed if differences in time between symptoms and carotid endarterectomy or carotid artery stenting are associated with differences in risk of periprocedural stroke or death. We analyzed the 1180 symptomatic patients in CREST who received their assigned procedure and had clearly defined timing of symptoms. Patients were classified into 3 groups based on time from symptoms to procedure: <15, 15 to 60, and >60 days. For carotid endarterectomy, risk of periprocedural stroke or death was not significantly different for the 2 later time periods relative to the earliest time period (hazard ratio, 0.74; 95% confidence interval, 0.22-2.49 for 15-60 days and hazard ratio, 0.91; 95% confidence interval, 0.25-3.33 for >60 days; P=0.89). For carotid artery stenting, risk of periprocedural stroke or death was also not significantly different for later time periods relative to the earliest time period (hazard ratio, 1.12; 95% confidence interval, 0.53-2.40 for 15-60 days and hazard ratio, 1.15; 95% confidence interval, 0.48-2.75 for >60 days; P=0.93). Time from symptoms to carotid endarterectomy or carotid artery stenting did not alter periprocedural safety, supporting early revascularization regardless of modality. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Issues to Be Addressed and Hopefully Resolved in the Carotid Revascularization Endarterectomy Versus Stenting Trial 2.

The superiority of carotid endarterectomy (CEA) plus best medical treatment (BMT) over BMT alone for the management of patients with asymptomatic carotid stenosis is based on randomized controlled trials that recruited patients up to 30 years ago. Best medical treatment has improved considerably since that time with respect to stroke prevention. Furthermore, a new carotid intervention has emerged during the last 2 decades and has gradually become established, that is, carotid artery stenting (CAS). Consequently, the efficacy of current BMT alone needs to be compared not only with CEA plus BMT but also with CAS plus BMT to determine which strategy achieves the optimal stroke prevention rates. This article highlights the purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) 2 and discusses the issues that CREST-2 will hopefully provide answers to.

Patients Consenting to or Declining Extended Follow-up (Up to Ten Years) in the Carotid Revascularization Endarterectomy (CEA) versus Stenting (CAS) Trial (CREST) (I2-5E)

Patients Consenting to or Declining Extended Follow-up (Up to Ten Years) in the Carotid Revascularization Endarterectomy (CEA) versus Stenting (CAS) Trial (CREST) (I2-5E)

Effect of patching on reducing restenosis in the carotid revascularization endarterectomy versus stenting trial.

The purpose is to determine whether patching during carotid endarterectomy (CEA) affects the perioperative and long-term risks of restenosis, stroke, death, and myocardial infarction as compared with primary closure. We identified all patients who were randomized and underwent CEA in Carotid Revascularization Endarterectomy versus Stenting Trial. CEA patients who received a patch were compared with patients who underwent CEA with primary closure without a patch. We compared periprocedural and 4-year event rates, 2-year restenosis rates, and rates of reoperation between the 2 groups. We further analyzed results by surgeon specialty. There were 1151 patients who underwent CEA (753 [65%] with patch and 329 [29%] with primary closure). We excluded 44 patients who underwent eversion CEA and 25 patients missing CEA data (5%). Patch use differed by surgeon specialty: 89% of vascular surgeons, 6% of neurosurgeons, and 76% of thoracic surgeons patched. Comparing patients who received a patch versus those who did not, there was a significant reduction in the 2-year risk of restenosis, and this persisted after adjustment by surgeon specialty (hazard ratio, 0.35; 95% confidence interval, 0.16-0.74; P=0.006). There were no significant differences in the rates of periprocedural stroke and death (hazard ratio, 1.58; 95% confidence interval, 0.33-7.58; P=0.57), in immediate reoperation (hazard ratio, 0.6; 95% confidence interval, 0.16-2.27; P=0.45), or in the 4-year risk of ipsilateral stroke (hazard ratio, 1.23; 95% confidence interval, 0.42-3.63; P=0.71). Patch closure in CEA is associated with reduction in restenosis although it is not associated with improved clinical outcomes. Thus, more widespread use of patching should be considered to improve long-term durability. http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Management of Vascular Risk Factors in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

BackgroundThe Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) is a multicenter randomized trial of stenting versus endarterectomy in patients with symptomatic and asymptomatic carotid disease. This study assesses management of vascular risk factors.Methods and ResultsManagement was provided by the patient's physician, with biannual monitoring results collected by the local site. Therapeutic targets were low‐density lipoprotein, cholesterol <100 mg/dL, systolic blood pressure <140 mm Hg, fasting blood glucose <126 mg/dL, and nonsmoking status. Optimal control was defined as achieving all 4 goals concurrently. Generalized estimating equations were used to compare risk factors at baseline with those observed in scheduled follow‐up visits for up to 48 months. In the analysis cohort of 2210, significant improvements in risk‐factor control were observed across risk factors for all follow‐up visits compared with baseline. At 48 months, achievement of the low‐density lipoprotein cholesterol goal improved from 59.1% to 73.6% (P<0.001), achievement of the systolic blood pressure goal improved from 51.6% to 65.1% (P<0.001), achievement of the glucose goal improved from 74.9% to 80.7% (P=0.0101), and nonsmoking improved from 74.4% to 80.9% (P<0.0001). The percentage with optimal risk‐factor control also improved significantly, from 16.7% to 36.2% (P<0.001), but nearly 2 of 3 study participants did not achieve optimal control during the study.ConclusionsSite‐based risk‐factor control improved significantly in the first 6 months and over the long term in CREST but was often suboptimal. Intensive medical management should be considered for future trials of carotid revascularization.Clinical Trial RegistrationURL: ClinicalTrials.gov. Unique identifier: NCT00004732.

Picking the Good Apples

The Carotid Revascularization Endarterectomy Versus Stenting Trial was completed with a low stroke and death rate. A lead-in series of patients receiving carotid artery stenting was used to select the physician-operators for the study, where performance was evaluated by complication rates and by peer review of cases. Herein, we assess the potential contribution of statistical evaluation of complication rates. The ability to discriminate between stent operators who can successfully meet the published guideline of <3% combined rate of stroke and death is calculated under the binomial distribution, based on a small consecutive case series (n=24 patients). A criterion of ≤2 stroke or death events among the 24 patients (<8% event rate) was required of operators. Setting such a high criterion, however, ensures an inability to exclude operators who cannot meet the criteria. In fact, if a good operator is defined as having a 2% event rate and a poor operator as a 6% event rate, even a series of 240 patients would (on average) still exclude 5.4% of the good operators and include 4.6% of the poor operators. The low periprocedural event rates in the trial suggest success in separating skillful operators from less skillful. However, it seems unlikely that statistical assessment of event rates in the lead-in contributed to successful selection, but rather successful selection was more likely because of peer review of subjective and other factors including patient volume and technical approaches. http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Effect of Carotid Revascularization Endarterectomy Versus Stenting Trial Results on Performance of Carotid Artery Stent Placement and Carotid Endarterectomy in United States (S51.005)

Effect of Carotid Revascularization Endarterectomy Versus Stenting Trial Results on Performance of Carotid Artery Stent Placement and Carotid Endarterectomy in United States (S51.005)

Treatment Options for Asymptomatic Carotid Artery Stenosis

Dr Beckman1 discussed the available options for the management of asymptomatic carotid artery stenosis, using a 78-year-old female patient with severe stenosis as the case. Beckman summarized the results of the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST),2 demonstrating that in asymptomatic patients, carotid artery stenting (CAS) is associated with similar outcomes compared with carotid endarterectomy (CEA). The patient preferred revascularization over optimal medical therapy and consequently underwent uneventful CAS.1

Abstract 79: Effect of Carotid Revascularization Endarterectomy Versus Stenting Trial Results on Performance of Carotid Artery Stent Placement and Carotid Endarterectomy in United States

Introduction: Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) results, published in 2010, showed no difference in composite outcome (stroke, myocardial infarction, or death) between carotid artery stent placement (CAS) and carotid endarterectomy (CEA). The impact of these results on the pre-existing practices has not been studied. The aim of our study is to determine whether any change in utilization and outcomes of CAS and CEA subsequent to the CREST results. Methods: We estimated the frequency of CAS and CEA procedures in the years 2009 (pre-CREST period) and 2011 (post-CREST period), using data from the National In-patient Sample (NIS). Pre- and post-CREST CAS and post-CREST CEA rates and outcomes were compared with pre-CREST CEA (reference). Results: A total of 225,191 patients underwent CEA or CAS in pre- and post-CREST period. The frequency of CAS did not change after CREST publication. In the pre-CREST period, CAS group (compared with CEA) were younger .Neurological complications, and in-hospital mortality was higher in the CAS group compared to CEA group in the pre-CREST analysis (p=0.008, 0.0003, 0.0004, respectively. In the post-CREST period, the frequency of CAS has remained unchanged in comparison to CEA. Neurological complications were more frequently reported in the post-CREST group (p&lt;0.0001 and 0.005, respectively). Post-procedure cardiac complications were not different in both pre and post CREST CAS group when compared with reference CEA group (p=0.8 and 0.6, respectively). After adjusting for age, gender and risk factors, the Odds ratio (OR) for moderate to severe disability was 1.0 (95% CI 0.8-1.2) in the pre-CREST CAS group and 0.7 (95%CI 0.6-0.9) in the post-CREST CAS group compared with the reference. Adjusted OR for neurological complications in the pre-CREST CAS group was 0.6 (95%CI 0.6-0.9) and 0.7 (95%CI 0.5-0.9) in the post-CREST CAS group. Conclusion: The frequency of CAS and CEA for carotid artery stenosis has not changed after the publication of CREST trial. The demographics, pre-treatment co-morbidity profile and in-hospital complications remain unchanged during the two time periods. CAS continues to have higher risk of post-operative neurological complications as reported in CREST trial.

Abstract 69: The Effect of Patching in Carotid Endarterectomy (CEA) on Reducing The Risk of Restenosis and Stroke in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

Objective: To compare the perioperative risk of any stroke, death and MI and the long-term risk of re-stenosis and stroke following CEA with patching (a prosthetic or vein patch sutured to the arterial opening to widen the closure) versus CEA with primary closure in CREST. Methods: We included patients who were randomized and underwent CEA in CREST. We compared peri-procedural and 4-year event rates and 2-year restenosis rates, in addition to rates of reoperation between the two groups. Re-stenosis was defined as elevated peak systolic velocity ≥3.0 m/s on carotid duplex US. Treatment differences were assessed using proportional hazard models adjusting for age, sex, and symptomatic status. Results: There were 1,148 patients who underwent CEA (755 {66%} patch; 328 {29%} primary closure). We excluded 43 patients who underwent eversion CEA and 24 patients missing CEA data (5%). There was no significant difference between the two groups with respect to age, sex, race and comorbidities (Table 1). There were significant reductions in the risk of any periprocedural stroke and death (HR 0.35, 95% CI 0.15-0.82, P&lt;0.02), in re-operation (OR 0.33, 95% CI 0.14-0.80, P&lt;0.01), in the 4-year risk of stroke (HR 0.52, 95% CI 0.28-0.97, P&lt;0.04) and in the 2-year risk of re-stenosis (HR 0.26, 95% CI 0.14-0.45, P&lt;0.0001) in the patch compared to the primary closure group (Table 2). Conclusion: Patch closure should be considered for all CEAs because of the association of patch closure with reductions in risk of periprocedural stroke and death, re-operation, and long-term clinical and anatomic durability.