Carotid Artery Stenting Trials Research Articles

Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

SummaryBackgroundAmong asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence.MethodsACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362.FindingsBetween Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21).InterpretationSerious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable.FundingUK Medical Research Council and Health Technology Assessment Programme.

Second Asymptomatic Carotid Surgery Trial (ACST-2): Randomised Comparison of Carotid Artery Stenting vs Carotid Endarterectomy

Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks, but from recent national registry data each causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: International multi-centre randomised trial of CAS vs CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were randomly allocated to CAS or CEA and followed at 1 month then annually, for mean 5 years. Procedural events were those within 30 days of the intervention. Intent-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and logrank methods. Trial registration: ISRCTN21144362. Findings: From 2008-20, 3625 patients in 130 centres were randomly allocated, 1811 CAS and 1814 CEA, with good compliance, good medical therapy and mean 5-year follow-up. In both groups, 1% suffered disabling stroke or death procedurally (15 allocated CAS, 18 CEA) and 2% had non-disabling procedural stroke (48 CAS, 29 CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2.5% in each group for fatal or disabling stroke, and 5.3% CAS vs 4.5% CEA for any stroke (RR=1.16, 95%CI 0.86-1.56; p=0.34). Combining RRs for any non-procedural stroke in all CAS vs CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR=1.11, 95% CI 0.94-1.31; p=0.21). Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects on fatal or disabling stroke are comparable. Clinical Trial Registration Details: Trial registration: ISRCTN21144362 Funding Information: ACST-2 is funded from the core support from the MRC, BHF and CR-UK for the University of Oxford’s Nuffield Department of Population Health (NDPH), and received grants from the BUPA Foundation and National Institute for Health Research (NIHR) Health Technology Assessment program. Analyses were performed in the MRC Population Health Research Unit, NDPH. AH is supported by the NIHR Oxford Biomedical Research Centre. Declaration of Interests: None declared. Ethics Approval Statement: Ethics approval was obtained at each centre and at the UK coordinating centre. Informed consent preceded randomisation.

Clinical trial of carotid artery stenting using dual-layer CASPER stent for carotid endarterectomy in patients at high and normal risk in the Japanese population

BackgroundThe dual-layer nitinol CASPER stent was designed to prevent plaque prolapse into its strut and periprocedural stroke.ObjectiveTo conduct a clinical trial for government approval of the device in patients at...

Long-term Clinical Outcomes of Elective Carotid Artery Stenting in Patients Undergoing Maintenance Hemodialysis.

Objective Carotid artery stenting (CAS) in patients undergoing maintenance hemodialysis is characterized by high complication rates. These patients are excluded from clinical trials of CAS. The purpose of our retrospective study was to investigate the long-term clinical outcomes of CAS in patients undergoing maintenance hemodialysis. Methods CAS was performed under local anesthesia. The technical success rate, periprocedural complications, 30-day major vascular event rate (stroke, myocardial infarction, and/or death), 3-month morbidity and mortality rates, and 5-year survival probability were investigated. Patients Nineteen patients undergoing maintenance hemodialysis were identified. Results The mean age of the patients was 69 years. Periprocedural complications occurred in two patients (confusion following CAS in one and transient hemiparesis in the other). Complete neurological recovery was achieved in both patients. No major cardiovascular events occurred within 30 days after CAS. Asymptomatic intracranial hemorrhage only occurred in one patient, and seven patients died during the follow-up period at a mean of 3.5 years after the procedure (range, 6 months to 8 years). No permanent neurologic deficit remained in the patient with intracranial hemorrhage. The causes of death were cardiovascular disease (n = 4), cancer (n = 2), and pneumonia (n = 1). No patients died of stroke. The 5-year survival probability in patients undergoing maintenance hemodialysis was 57%. Conclusion CAS in maintenance hemodialysis patients may be feasible and effective for the prevention of stroke with proper case selection, appropriate technique and strict perioperative management. The most common causes of death during the follow-up of maintenance hemodialysis patients were diseases other than stroke.

Comparison of Hospital Outcomes of Transcarotid Artery Revascularization with Flow Reversal (TCAR) Vs. Carotid Endarterectomy (CEA)

Introduction - TransCarotid Artery Revascularization with flow reversal (TCAR) offers a less invasive option to carotid endarterectomy (CEA) in high risk patients and has the lowest reported overall stroke rate for any prospective trial of carotid artery stenting (CAS). This study compares initial in-hospital outcomes of CEA and TCAR using the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) TCAR Surveillance Project (TSP) done in collaboration with the Centers for Medicare & Medicaid Services (CMS) to create more information for future coverage decisions. Methods - The SVS TSP isdesigned to evaluate the safety and efficacy of TCAR in real world practice, using a contemporary comparison to CEA.Patients enrolled in this project were compared to those undergoing CEA during the same time period (2016-2017). The primary outcome was a composite of in-hospital stroke and death. Average treatment effects were estimated via augmented inverse-probability weighting (AIPW). Additional analysis was performed using multivariable logistic regression as well as various matching techniques such as propensity score matching and coarsened exact matching (CEM).Adjusted analysis accounted for age, gender, race, insurance status, CAD, CHF, CKD, COPD, symptomatic status, restenosis, prior vascular procedures, degree of ipsilateral stenosis and preoperative medication use. Results - A total of 637 patients underwent TCAR compared to 12,049 patients who underwent CEA. Patients undergoing TCAR were older (median age 74 vs.71 years), more likely to be symptomatic (33.6% vs. 27.9%),and had more medical comorbidities such as CAD (47.3% vs.26.6%), CHF (19.8% vs.11.1%), COPD (26.5% vs. 22.3%), CKD (39.9% vs. 33.6%), and prior vascular procedures compared to CEA patients (All p<0.01). The majority of TCAR procedures were done under general anesthesia (79.0% vs.90.3% in CEA, p<0.001). On average, TCAR was 36.7 minutes shorter than CEA (78.0±33.9 vs. 114.7±42.5, p<0.001). On univariate analysis, there were no differences in the rates of in-hospital stroke/death (1.3% vs. 1.7%, p=0.42), overall neurological events (2.0% vs.1.9%, p=0.83), in-hospital MI (0.7% vs.1.1%, p=0.31) and 30-day mortality (0.5% vs. 0.9%, p=0.08) between CEA and TCAR, respectively. Patients undergoing CEA had higher rates of cranial nerve injury (2.8% v.0.8%, p<0.01) and postoperative hypertension (18.3% vs. 11.6%, p<0.001) compared to TCAR patients. On multivariable analysis and using different matching methods, there were no differences in overall stroke, stroke/death or overall neurologic events (Figure 1). The absolute difference in adjusted stroke/death rates between the two groups was 0.3% [95%CI: -1.7%, 1.0%, p=0.64]. Conclusion - Despite a substantially higher medical risk in patients undergoing TCAR, preliminary analysis of the SVS-VQI TCAR Surveillance Project showed similar in-hospital stroke/death rates between TCAR and CEA after multivariable adjustment and rigorous matching. Further studies with larger sample sizes and longer follow will be needed to establish the equivalence of TCAR compared to CEA.

In-hospital outcomes of transcarotid artery revascularization and carotid endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative

ObjectiveTranscarotid artery revascularization (TCAR) with flow reversal offers a less invasive option for carotid revascularization in high-risk patients and has the lowest reported overall stroke rate for any prospective trial of carotid artery stenting. However, outcome comparisons between TCAR and carotid endarterectomy (CEA) are needed to confirm the safety of TCAR outside of highly selected patients and providers. MethodsWe compared in-hospital outcomes of patients undergoing TCAR and CEA from January 2016 to March 2018 using the Society for Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project registry and the Society for Vascular Surgery Vascular Quality Initiative CEA database, respectively. The primary outcome was a composite of in-hospital stroke and death. ResultsA total of 1182 patients underwent TCAR compared with 10,797 patients who underwent CEA. Patients undergoing TCAR were older (median age, 74 vs 71 years; P < .001) and more likely to be symptomatic (32% vs 27%; P < .001); they also had more medical comorbidities, including coronary artery disease (55% vs 28%; P < .001), chronic heart failure (20% vs 11%; P < .001), chronic obstructive pulmonary disease (29% vs 23%; P < .001), and chronic kidney disease (39% vs 34%; P = .001). On unadjusted analysis, TCAR had similar rates of in-hospital stroke/death (1.6% vs 1.4%; P = .33) and stroke/death/myocardial infarction (MI; 2.5% vs 1.9%; P = .16) compared with CEA. There was no difference in rates of stroke (1.4% vs 1.2%; P = .68), in-hospital death (0.3% vs 0.3%; P = .88), 30-day death (0.9% vs 0.4%; P = .06), or MI (1.1% vs 0.6%; P = .11). However, on average, TCAR procedures were 33 minutes shorter than CEA (78 ± 33 minutes vs 111 ± 43 minutes; P < .001). Patients undergoing TCAR were also less likely to incur cranial nerve injuries (0.6% vs 1.8%; P < .001) and less likely to have a postoperative length of stay >1 day (27% vs 30%; P = .046). On adjusted analysis, there was no difference in terms of stroke/death (odds ratio, 1.3; 95% confidence interval, 0.8-2.2; P = .28), stroke/death/MI (odds ratio, 1.4; 95% confidence interval, 0.9-2.1, P = .18), or the individual outcomes. ConclusionsDespite a substantially higher medical risk in patients undergoing TCAR, in-hospital stroke/death rates were similar between TCAR and CEA. Further comparative studies with larger samples sizes and longer follow-up will be needed to establish the role of TCAR in extracranial carotid disease management.

Long-term outcomes of stenting and endarterectomy for symptomatic carotid stenosis: a preplanned pooled analysis of individual patient data

The risk of periprocedural stroke or death is higher after carotid artery stenting (CAS) than carotid endarterectomy (CEA) for the treatment of symptomatic carotid stenosis. However, long-term outcomes have not been sufficiently assessed. We sought to combine individual patient-level data from the four major randomised controlled trials of CAS versus CEA for the treatment of symptomatic carotid stenosis to assess long-term outcomes. We did a pooled analysis of individual patient-level data, acquired from the four largest randomised controlled trials assessing the relative efficacy of CAS and CEA for treatment of symptomatic carotid stenosis (Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis trial, Stent-Protected Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy trial, International Carotid Stenting Study, and Carotid Revascularization Endarterectomy versus Stenting Trial). The risk of ipsilateral stroke was assessed between 121 days and 1, 3, 5, 7, 9, and 10 years after randomisation. The primary outcome was the composite risk of stroke or death within 120 days after randomisation (periprocedural risk) or subsequent ipsilateral stroke up to 10 years after randomisation (postprocedural risk). Analyses were intention-to-treat, with the risk of events calculated using Kaplan-Meier methods and Cox proportional hazards analysis with adjustment for trial. In the four trials included, 4775 patients were randomly assigned, of whom a total of 4754 (99·6%) patients were followed up for a maximum of 12·4 years. 21 (0·4%) patients immediately withdrew consent after randomisation and were excluded. Median length of follow-up across the studies ranged from 2·0 to 6·9 years. 129 periprocedural and 55 postprocedural outcome events occurred in patients allocated CEA, and 206 and 57 for those allocated CAS. After the periprocedural period, the annual rates of ipsilateral stroke per person-year were similar for the two treatments: 0·60% (95% CI 0·46-0·79) for CEA and 0·64% (0·49-0·83) for CAS. Nonetheless, the periprocedural and postprocedural risks combined favoured CEA, with treatment differences at 1, 3, 5, 7, and 9 years all ranging between 2·8% (1·1-4·4) and 4·1% (2·0-6·3). Outcomes in the postprocedural period after CAS and CEA were similar, suggesting robust clinical durability for both treatments. Although long-term outcomes (periprocedural and postprocedural risks combined) continue to favour CEA, the similarity of the postprocedural rates suggest that improvements in the periprocedural safety of CAS could provide similar outcomes of the two procedures in the future. None.

Stroke : Highlights of Selected Articles

<i>Stroke</i> : Highlights of Selected Articles

Transcarotid artery revascularization versus transfemoral carotid artery stenting in the Society for Vascular Surgery Vascular Quality Initiative

BackgroundRecent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transcarotid artery stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of carotid artery stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). MethodsThe Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary artery disease, congestive heart failure, prior coronary artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. ResultsCompared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P < .001]). After multivariable adjustment, there was a trend of increased stroke or death rates in TFCAS compared with TCAR, but it was not statistically significant (2.5% vs 1.7%; P = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P = .03), independent of symptom status. Coarsened exact matching showed similar results. ConclusionsCompared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.

Trials and Frontiers in Carotid Endarterectomy and Stenting.

Based on the strength of randomized trials from the 1990s, major societal guidelines recommend carotid endarterectomy (CEA) for severe (≥70%), symptomatic carotid stenosis if an operative stroke/death rate of <6% can be maintained (history and major trials in carotid revascularization are summarized in the online-only Data Supplement).1–4 Though the benefit is less evident, most guidelines also recommend consideration of CEA for 50% to 69% symptomatic stenosis.2–4 There are subtle differences in recommendations regarding carotid artery stenting (CAS) in symptomatic patients. Some guidelines stipulate that CEA should be preferred over CAS in patients with severe (≥70%) symptomatic carotid stenosis,2,5 especially if >70 years old,4 whereas others position CAS as an alternative.1,3 Though the risk of operative stroke/death is higher with CAS, major randomized clinical trials (RCTs) report event rates under the recommended 6% cutoff for both treatment modalities. Regarding asymptomatic disease, CEA is recommended for patients with stenosis ≥60% to 70% in highly selected patients as long as operative stroke/death rates <3% can be maintained.1 A predicted life expectancy of at least 3 to 5 years has also been suggested.2 The 3% threshold has been easily met by CEA cohorts in the CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial; 1.4%)6 and the ACT1 (Asymptomatic Carotid Trial; 1.7%),7 suggesting that an even lower threshold may be appropriate. Controversially, some guidelines have recommended that CAS can be considered in highly selected patients with asymptomatic carotid stenosis ≥60% to 70%,1,4,8 whereas others argue that the evidence remains insufficient.2 The lack of consensus in the management of asymptomatic carotid stenosis is reflective of an ongoing need for high-quality RCT data to guide practice. ### CEA Operative Stroke Risk and High Risk Designation Most clinical trials in carotid revascularization have focused …

VESS05. In-Hospital Outcomes of Transcarotid Artery Revascularization and Carotid Endarterectomy in the Society for Vascular Surgery Vascular Quality Initiative

Transcarotid artery revascularization (TCAR) offers a less invasive option to carotid endarterectomy (CEA) in high-risk patients and has the lowest reported overall stroke rate for any prospective trial of carotid artery stenting. This study compares initial in-hospital outcomes of CEA and TCAR using the Society for Vascular Surgery (SVS) Vascular Quality Initiative TCAR Surveillance Project done in collaboration with the Centers for Medicare and Medicaid Services to create more information for future coverage decisions. The SVS TCAR Surveillance Project is designed to evaluate the safety and efficacy of TCAR in real-world practice, using a contemporary comparison to CEA. Patients enrolled in this project were compared with those undergoing CEA during the same period (2016-2017). The primary outcome was a composite of in-hospital stroke and death. Average treatment effects were estimated by augmented inverse-probability weighting. Additional analysis was performed using multivariable logistic regression as well as various matching techniques, such as propensity score matching and coarsened exact matching. Adjusted analysis accounted for age, sex, race, insurance status, coronary artery disease, congestive heart failure, chronic kidney disease, chronic obstructive pulmonary disease, symptomatic status, restenosis, prior vascular procedures, degree of ipsilateral stenosis, and preoperative medication use. A total of 637 patients underwent TCAR compared with 12,049 patients who underwent CEA. Patients undergoing TCAR were older, more likely to be symptomatic, and had more medical comorbidities, such as coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, chronic kidney disease, and prior vascular procedures, compared with CEA patients (Table). The majority of TCAR procedures were done under local/regional anesthesia (95.3% vs 9.7% in CEA; P < .001). On average, TCAR was 36.7 minutes shorter than CEA (78.0 ± 33.9 vs 114.7 ± 42.5 minutes; P < .001). On univariate analysis, there were no differences in the rates of in-hospital stroke/death (1.3% vs 1.7%; P = .42), overall neurologic events (2.0% vs 1.9%; P = .83), in-hospital myocardial infarction (0.7% vs 1.1%; P = .31), and 30-day mortality (0.5% vs 0.9%; P = .08) between CEA and TCAR, respectively. Patients undergoing CEA had higher rates of cranial nerve injury (2.8% vs 0.8%; P < .01) and postoperative hypertension (18.3% vs 11.6%; P < .001) compared with TCAR patients. On multivariable analysis and using different matching methods, there were no differences in overall stroke, stroke/death, or overall neurologic events (Fig). The absolute difference in adjusted stroke/death rates between the two groups was 0.3% (95% confidence interval, −1.7% to 1.0%; P = .64). Despite a substantially higher medical risk in patients undergoing TCAR, analysis of the preliminary results from the SVS Vascular Quality Initiative TCAR Surveillance Project showed similar in-hospital stroke/death rates between TCAR and CEA after multivariable adjustment and rigorous matching. Further studies with larger sample sizes and longer follow-up will be needed to establish the equivalence of TCAR compared with CEA.TableBaseline and perioperative characteristics of patients undergoing transcarotid artery revascularization (TCAR) vs carotid endarterectomy (CEA) between 2016 and 2017TCAR (n = 637)CEA (n = 12,049)Age, years, median (IQR)74 (66-80)71 (64-77)<.001Female224 (35.2)4680 (38.8).06Race.11 White573 (90.0)11,053 (91.8) Black29 (4.6)530 (4.4) Others35 (5.5)464 (3.9) Hispanic or Latin ethnicity36 (5.7)425 (3.5).01Symptomatic status214 (33.6)3357 (27.9)<.01Coronary artery disease301 (47.3)3201 (26.6)<.001Prior congestive heart failure126 (19.8)1338 (11.1)<.001Hypertension581 (91.2)10,729 (89.1).09COPD169 (26.5)2684 (22.3).01CKD (GFR <60 mL/min)249 (39.9)3946 (33.6)<.01Smoking.08 Prior344 (54.0)5986 (49.7) Current155 (24.3)3040 (25.3)Prior amputation20 (3.1)93 (0.8)<.001Prior ipsilateral CEA or CAS115 (18.1)235 (2.0)<.001Prior contralateral CEA or CAS117 (18.4)1669 (13.9)<.01Preoperative medications Aspirin570 (89.5)10,084 (83.7)<.001 Antiplatelet549 (86.2)3990 (33.1)<.001 Statins561 (88.1)10,036 (83.3)<.01 Anticoagulants85(13.3)1241 (10.3).02Anesthesia technique<.001 Local/regional607 (95.3)1162 (9.7) General30 (4.7)10,877 (90.3)Operative time, minutes, mean (±SD)78.0 (±33.9)114.7 (±42.5)<.001CAS, Carotid artery stenting; CKD, chronic kidney disease; COPD, chronic obstructive pulmonary disease; GFR, glomerular filtration rate; IQR, interquartile range; SD, standard deviation.Values are reported as No. (%) unless otherwise indicated. Open table in a new tab

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 …

Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal

This report presents the 30-day results of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial and evaluates the safety and efficacy of ENROUTE Transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcarotid neuroprotection system that provides direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting (CAS). A prospective, single-arm, multicenter clinical trial was performed to evaluate the use of the ENROUTE Transcarotid NPS during CAS procedures performed in patients considered to be at high risk for complications from carotid endarterectomy. Symptomatic patients with ≥50% stenosis and asymptomatic patients with ≥70% stenosis were eligible to be treated with any U.S. Food and Drug Administration-approved carotid artery stent. The primary end point was the composite of all stroke, myocardial infarction (MI), and death at 30days postprocedure as defined in the Food and Drug Administration-approved study protocol. Secondary end points included cranialnerve injury; 30-day stroke, death, stroke/death, and MI; acute device, technical, and procedural success; and access site complications. All major adverse events were adjudicated by an independent clinical events committee. Between November 2012 and July 2014, 208 patients were enrolled at 18 sites. Sixty-seven patients were enrolled as lead-in cases, and 141 were enrolled in the pivotal phase. In the pivotal cohort, 26% were symptomatic and 75% were asymptomatic. Acute device and technical success were 99% (140 of 141). By hierarchical analysis, the all-stroke rate in the pivotal group was 1.4% (2 of 141), stroke and death was 2.8% (4 of 141), and stroke, death and MI was 3.5% (5 of 141). One patient (0.7%) experienced postoperative hoarseness from potential Xth cranial nerve injury, which completely resolved at the 6-month follow-up visit. The results of the ROADSTER trial demonstrate that the use of the ENROUTE Transcarotid NPS is safe and effective at preventing stroke during CAS. The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS.

The impact of regulatory approval and Medicare coverage on outcomes of carotid stenting

Carotid artery stenting (CAS) was introduced in the United States nearly a decade ago as a novel treatment of severe carotid stenosis. Voluminous and high-quality prospective data permit analysis of longitudinal trends in CAS outcomes. Outcomes from all prospective trials with the Food and Drug Administration (FDA) oversight from 2000-2011 were reviewed, as were the subset of studies using a single CAS system. All studies shared common inclusion/exclusion criteria, endpoints, independent assessment/adjudication of neurological events, and were conducted in accordance with FDA regulations. Death and stroke (DS) rates from FDA-approved studies in high-surgical-risk patients were assessed. Between 2000 and 2011, two distinct periods with clustered and differentiated outcomes in CAS IDE trials were observed, separated by FDA approval and Centers for Medicare and Medicaid Services (CMS) coverage in 2004-2005. The mean 30-day DS rate in the first wave (2000-2004) of CAS trials was 5.3% (95% CI: 4.6-6.2%), and fell significantly to 2.6% (95% CI: 1.9-3.7%; P = 0.0001) in the second wave (2006-2011). This decline occurred during a simultaneous, independent 24-fold increase in monitored CAS activity. This decline in DS rates was observed in symptomatic and asymptomatic patients, alike independent of device tested. Declines in periprocedural DS rates in CAS appear linked to regulatory and coverage approvals leading to increased operator experience along with continued regulatory oversight, and provide insight into the introduction of other novel therapies.

Carotid artery stenting

From the earliest experiences with carotid artery stenting (CAS) presumptive high risk features have included thrombus-containing lesions, heavily calcified lesions, very tortuous vessels, and near occlusions. In addition patients have been routinely excluded from CAS trials if they have contra-indications to dual antiplatelet therapy (aspirin and thienopyridines), a history of bleeding complications and severe peripheral arterial disease (PAD) making femoral artery vascular access difficult. Variables that increase the risk of CAS complications can be attributed to patient characteristics, anatomic or lesion features, and procedural factors. Clinical features such as older age (≥80 years), decreased cerebral reserve (dementia, multiple prior strokes, or intracranial microangiopathy) and angiographic characteristics such as excessive tortuosity (more than two 90° bends within 5 cm of the target lesion) and heavy calcification (concentric calcification ≥ 3 mm in width) have been associated with increased CAS complications. Other high risk CAS features include those that prolong catheter or guide wire manipulation in the aortic arch, make crossing a carotid stenosis more difficult, decrease the likelihood of successful deployment or retrieval of an embolic protection device (EPD), or make stent delivery or placement more difficult. Procedure volume for the operator and the catheterization laboratory team are critical elements in reducing the risk of the procedure. In this article, we help CAS operators better understand procedure risk to allow more intelligent case selection, further improving the outcomes of this emerging procedure.

Advances in Stroke

The indications for microsurgery in cerebrovascular pathology have been placed under increased scrutiny, given the continuous refinement of endovascular techniques. Several recent randomized studies and subgroup analyses of concluded studies have been particularly illuminating in this sense and will be the primary focus of this brief review. The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) has shown that the risk of perioperative stroke is slightly higher after carotid artery stenting (CAS) than after carotid endarterectomy (CEA), whereas the reverse is true for the risk of periprocedural myocardial infarction.1 Over the past year, the CREST investigators have also reported the results of some prespecified and some ad hoc subgroup analyses. Earlier trials of CAS versus CEA had suggested higher risk of restenosis after endovascular treatment of carotid stenosis compared with CEA. However, in CREST after 2 years, the incidence of restenosis >70% or occlusion was similar in the CAS (6%) and the CEA (6.3%) groups, suggesting that restenosis may not be a major concern if endovascular treatment is contemplated.2 Female sex, diabetes mellitus, and dyslipidemia were associated with higher risk of restenosis in both groups.2 Smoking increased the risk of restenosis in patients undergoing CEA but not after stenting.2 Subgroup analysis by age confirmed that increasing age is associated with a higher risk of periprocedural stroke after CAS but did not affect …

Results of carotid artery stenting with distal embolic protection with improved systems: Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) trial

The Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) study was performed to evaluate the safety and effectiveness of two devices for carotid artery stenting (CAS) in the treatment of carotid artery stenosis in patients at high risk for carotid endarterectomy (CEA): (1) a new embolic protection device, the Emboshield Pro (Abbott Vascular, Abbott Park, Ill), using the periprocedural composite end point of 30-day death, stroke, and myocardial infarction (DSMI), and (2) a carotid stent in conjunction with an embolic protection device (EPD) using the DSMI periprocedural composite end point plus ipsilateral stroke at up to 3 years for long-term evaluation. This prospective, multicenter clinical trial enrolled 220 consecutive participants between November 29, 2006, and January 14, 2008, followed by a second cohort of 102 participants between January 14 and June 18, 2008. Enrolled participants had carotid stenosis (symptomatic >50% or asymptomatic >80%). The first 220 subjects underwent distal EPD placement with a new large-diameter filter, and the second cohort of 102 underwent placement of an older EPD that is no longer manufactured. All 322 participants were to be treated with a dedicated carotid stent with a tapered, small, closed-cell design (Xact; Abbott Vascular) and were to be included in the long-term evaluation. Independent neurologic assessment was performed before CAS and at 1 day, 30 days, and annually after CAS. All primary end point events were independently adjudicated by a central committee. The periprocedural composite end point of DSMI (95% confidence interval) in the first 220 participants was 2.3% (0.74%, 5.22%), with a combined death and stroke rate of 1.8% (0.50%, 4.59%) and a rate of death and major stroke of 0.5% (0.01%, 2.51%). As of January 3, 2011, the median follow-up for the entire 322-subject cohort for the long-term evaluation was 2.8 years. Freedom from the periprocedural composite of DSMI plus ipsilateral stroke thereafter was 95.4%, with an annualized ipsilateral stroke rate of 0.4%. CAS outcomes in patients at high risk for CEA have improved from earlier carotid stent trials. With periprocedural rates of DSMI of 2.3%, death or stroke at 1.8%, and death or major stroke rate of 0.5%, PROTECT has the lowest rate of periprocedural complications among other comparable single-arm CAS trials in patients at high risk for CEA.

Carotid artery revascularization with distal protection in high‐surgical‐risk patients in routine clinical practice: Rationale and design of the CABANA safety surveillance program

Continuous improvement in carotid artery stenting (CAS) outcomes, especially for periprocedural death and stroke in high-surgical-risk patients, have been seen in recent randomized trials of CAS versus carotid endarterectomy and CAS registries. However, these studies use stringent inclusion/exclusion criteria for patient, institution, and physician selection. The Carotid Stenting Boston Scientific Surveillance Program (CABANA) study was initiated to evaluate periprocedural outcomes with modern versions of the Carotid Wallstent and FilterWire EZ System for operators with a wide range of clinical specialties, CAS experience and training levels, in patients with a broad range of high-surgical-risk conditions and lesion types. This prospective, single-arm study enrolled 1,097 subjects with 1,098 carotid artery lesions at 99 study centers. Investigators were grouped into one of three tiers according to whether they had a high, medium, or low level of previous CAS experience and were also categorized by their CAS-credential-based training requirements for the CABANA study. Follow-up at 30 days includes clinical evaluation and independent neurological and NIH stroke scale assessments. The primary endpoint rate of 30-day composite stroke, death, and MI, as well as the rates of these individual events, will be evaluated across the overall study, by physician experience tier, and by physician training tier. The evaluation of periprocedural CAS safety in a real-world environment with modern devices in high-surgical-risk patients treated by physicians with a broad range of training and experience will better inform treatment decisions in the future.

Invited commentary

Invited commentary

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease: Executive Summary

Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .e422 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .e424 2. Recommendations for Duplex Ultrasonography to Evaluate Asymptomatic Patients With Known or Suspected Carotid Stenosis . . . . . . . . . . . . . . . . .e425 3. Recommendations for Diagnostic Testing in Patients With Symptoms or Signs of Extracranial Carotid Artery Disease . . . . . . . . . . . . .e426 4. Recommendations for the Treatment of Hypertension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .e426 5. Recommendation for Cessation of Tobacco Smoking. . . . . . . . . . . . . . . . . . . . . . . . . . .e426 6. Recommendations for Control of Hyperlipidemia. . . . . . . . . . . . . . . . . . . . . . . . . . . . .e427 7. Recommendations for Management of Diabetes Mellitus in Patients With Atherosclerosis of the Extracranial Carotid or Vertebral Arteries. . . . . . . . . . . . …