Why Calls for More Routine Carotid Stenting Are Currently Inappropriate: An International, Multispecialty, Expert Review and Position Statement (original) (raw)
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Circulation, 2011
Background-To evaluate outcomes after carotid artery stenting in larger real-world populations, the Food and Drug Administration mandated that companies conduct postmarketing surveillance (PMS) studies of approved stent systems. Whether PMS studies are representative of carotid artery stenting in routine clinical practice has not been established. Methods and Results-Within the National Cardiovascular Database Registry-Carotid Artery Revascularization and Endarterectomy (NCDR CARE) Registry, we compared patient and procedural characteristics, in-hospital outcomes, and subsequent all-cause mortality after carotid artery stenting in PMS study participants and nonparticipants. We conducted both crude and propensity score-adjusted comparisons for all outcomes between groups. Compared with nonparticipants, participants in PMS studies had lower rates of symptomatic carotid artery disease within the preceding 6 months, prior stroke, and acute evolving stroke at baseline. The PMS study participants had lower unadjusted rates of combined in-hospital death, stroke, or myocardial infarction (2.3% versus 4.1%; PϽ0.001), driven by lower rates of stroke (1.7% versus 2.7%; Pϭ0.005) and death (0.3% versus 1.4%; PϽ0.001). Differences in survival persisted after propensity score adjustment (odds ratio, 0.44; 95% confidence interval, 0.21 to 0.95; Pϭ0.04 for in-hospital mortality; and hazard ratio, 0.80; 95% confidence interval, 0.66 to 0.97; Pϭ0.02 for 2-year mortality). Baseline differences in neurological history explained the largest proportion of the difference in outcomes between groups. Conclusions-Participants in PMS studies for carotid artery stenting have different clinical and procedural characteristics and lower mortality compared with nonparticipants. Extrapolating results from PMS studies of carotid artery stenting to larger real-world settings should be done only with great caution. (Circulation. 2011;123:1384-1390.) Key Words: carotid arteries Ⅲ carotid stenting Ⅲ outcomes research Ⅲ registries W ith the explosion of new therapeutic interventions, pharmaceutical and device companies have begun designing very focused randomized trials to maximize the probability of successfully demonstrating the benefit of novel interventions over standard therapy. Accordingly, the Food and Drug Administration has increasingly granted approval to new treatments conditioned on requirements that manufacturers conduct postmarketing surveillance (PMS) studies of their treatments, with the goal of evaluating their performance under more real-world circumstances. 1,2 However, although results from PMS studies have often been cast as representing those that might be seen in everyday practice, 1-3 explicit demonstration that PMS study patients are truly representative of the broader population undergoing treatment with approved devices and medications in the community is lacking. Clinical Perspective on p 1390 One important example is that of the treatment for carotid artery stenosis. Carotid artery stenting (CAS) has emerged as an alternative to carotid endarterectomy for stroke prevention in selected patients with carotid artery stenosis. 4-9 The Food Continuing medical education (CME) credit is available for this article. Go to http://cme.ahajournals.org to take the quiz.
American Journal of Neuroradiology, 2021
BACKGROUND AND PURPOSE: Published data regarding embolic protection device efficacy is mixed, and its use during carotid artery stent placement remains variable. We, therefore, examined the frequency of embolic protection device use and its association with outcomes after carotid artery stent placement using a national quality improvement data base. MATERIALS AND METHODS: Patients undergoing carotid artery stent placement with or without embolic protection devices were identified in the American College of Surgeons National Surgical Quality Improvement Program data base. The primary outcome was the incidence of major adverse cardiovascular events (defined as death, stroke, or myocardial infarction/arrhythmia) within 30 days. Propensity scoring was used to create 2 matching cohorts of patients using demographic and baseline variables. RESULTS: Between 2011 and 2018, among 1200 adult patients undergoing carotid artery stent placement, 23.8% did not have embolic protection devices. There was no trend toward increased embolic protection device use with time. Patients without embolic protection device use received preoperative antiplatelets less frequently (90.6% versus 94.6%, P ¼ .02), underwent more emergent carotid artery stent placement (7.2% versus 3.6%, P ¼ .01), and had a higher incidence of major adverse cardiovascular events (OR ¼ 1.81; 95% CI, 1.11-2.94) and stroke (OR ¼ 3.31; 95% CI, 1.71-6.39). After compensating for baseline imbalances using propensity-matched cohorts (n ¼ 261 for both), carotid artery stent placement without an embolic protection device remained associated with increased major adverse cardiovascular events (9.2% versus 4.2%; OR ¼ 2.30; 95% CI, 1.10-4.80) and stroke (6.5% versus 1.5%; OR ¼ 4.48; 95% CI, 1.49-13.49). CONCLUSIONS: Lack of embolic protection device use during carotid artery stent placement is associated with a 4-fold increase in the likelihood of perioperative stroke. Nevertheless, nearly one-quarter of patients in the American College of Surgeons National Surgical Quality Improvement Program underwent unprotected carotid artery stent placement. Efforts targeting improved embolic protection device use during carotid artery stent placement are warranted.
ACCF/SCAI/SVMB/SIR/ASITN 2007 Clinical Expert Consensus Document on Carotid Stenting
Journal of the American College of Cardiology, 2007
atic high-risk patients to determine the relative merits of CAS compared with best medical therapy. Training and Credentialing Operators should previously have achieved a high level of proficiency in catheter-based intervention, complete dedicated training in CAS, and be credentialed at their hospital. Detailed clinical documents on training and credentialing for CAS have been published by 2 multispecialty consensus groups. The elements for competency include requirements for cognitive, technical, and clinical skills, including cervicocerebral angiography and CAS. Hospitals are required to maintain independent oversight of CAS outcomes by a hospital-based oversight committee. The CMS has created facility credentialing requirements for CAS reimbursement. Individual operators and institutions are required by CMS to track their outcomes and to make their data available for submission to a national database.
Carotid artery stenting and patient outcomes: the CABANA surveillance study
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2014
The purpose of the prospective, multicenter, nonrandomized CABANA study was to evaluate periprocedural clinical outcomes in high surgical risk patients with carotid artery stenosis treated with the Carotid WALLSTENT plus FilterWire EZ Embolic Protection System by a diverse group of clinicians. There is a need for additional evidence evaluating carotid artery stenting (CAS) performed by operators with various experience and training levels. The study enrolled symptomatic (≥50% carotid artery stenosis) and asymptomatic (≥80% carotid stenosis) patients at high risk for carotid endarterectomy. Study centers were grouped into three tiers based on previous CAS experience while individual operators were grouped by their CAS training. The primary endpoint was the 30-day composite of major adverse events [MAEs; including stroke, death, and myocardial infarction (MI)]. Individual event rates were evaluated across the overall study, and by center experience and physician training tier. Of 1,09...
Current status of carotid artery stenting
Journal of Vascular Surgery, 2006
This Clinical Update summarizes the results of larger case series, industry-sponsored registries, and randomized trials of carotid artery stenting (CAS). In >20 case series that studied >24,000 patients undergoing CAS, 51% of patients were symptomatic, most procedures (97%) resulted in successful stent deployment, and 30-day stroke rates varied from 1% to 8%, with a trend toward lower rates as experience and embolic protection device (EPD) use increased. In 12 industry-sponsored registries (none were published in peer-reviewed journals), 30-day stroke rates varied from 2% to 7%, and 30-day combined adverse events, including stroke, death, and myocardial infarction, were 3% to 9%. More than 12 randomized trials comparing CAS and carotid endarterectomy (CEA) have been initiated since 1998. Results have varied over time, depending on the population studied and the technology used. However, the largest and most recent results of the completed SAPPHIRE trial in high-risk patients undergoing CAS with the use of EPDs demonstrated that CAS is at least not inferior to CEA, with a 1-year combined adverse event rate of 12% for CAS and 20% for CEA (P ؍ .05). Other ongoing trials will address not only whether CAS could be superior to CEA in high-risk patients but also, more importantly, whether CAS is beneficial in other subgroups, such as low-risk and asymptomatic patients. ( J Vasc Surg 2006;43:406-11.) From the Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, a and the Department of Vascular Surgery, Beth Israel Deaconess Medical Center. b Competition of interest: none.
Carotid angioplasty and stenting, success relies on appropriate patient selection
Journal of Vascular Surgery, 2008
Objective: Carotid angioplasty and stenting (CAS) is a percutaneous alternative to carotid endarterectomy (CEA) for treating patients with carotid artery stenosis. This study sought to evaluate whether patients at increased perioperative risk for CEA may be treated with CAS while maintaining equivalent outcomes. Methods: This study was a nonblinded, retrospective analysis of data obtained from September 2002 to present in the CAS group and from January 1997 to present in the CEA group. Two hundred thirty-one CAS and 647 CEA procedures were performed. Patients were selected for CAS based on criteria that placed them at increased risk for standard CEA surgery. Except for percentage women treated, baseline demographics did not differ between patients treated with CAS and CEA: mean age (72.0 years [range 46-94] vs 70.5 years [range 42-92], P ؍ NS), mean follow-up (12.8 ؎ 11.8 months vs 8.7 ؎ 10.0 months, P ؍ NS) and percentage women treated (41.4% vs 32.3%, P ؍ .03). Cerebral protection devices were used in 228/231 patients treated with CAS, and each patient underwent an NIH Stroke Scale assessment 24 hours postoperatively and at 30 days follow-up by an independent observer. Results: Preoperative neurologic symptoms did not differ between patients treated with CAS and CEA: amaurosis fugax (6.06% vs 6.96%, P ؍ NS), transient ischemic attacks (13.4% vs 13.9%, P ؍ NS), strokes (19.9% vs 14.1%, P ؍ NS) and total symptoms (27.7% vs 30.5%, P ؍ NS). Due to the selection of patient groups based on predefined clinical characteristics, factors associated with an increased risk of complications from standard CEA surgery were generally more prevalent in patients treated with CAS: neck irradiation (6.06% vs 1.24%, P < .001), neck dissection for cancer therapy (7.8% vs 1.5%, P < .001), prior ipsilateral CEA (15.2% vs 3.4%, P < .001), contralateral carotid artery occlusion (12.1% vs 1.1%, P < .001), modified Goldman Cardiac Risk II-moderate risk (26.0% vs 11.3%, P < .001) and modified Goldman Cardiac Risk III-high risk (16.4% vs 2.1%, P < .001) in patients treated with CAS and CEA, respectively. Perioperative outcomes did not differ between patients treated with CAS and CEA: myocardial infarction (MI) (1.7% vs 2.6%, P ؍ NS), stroke without residual symptoms (1.3% vs 1.2%, P ؍ NS), stroke with residual symptoms (0.4% vs 0.8%, P ؍ NS), mortality (0.4% vs 0.6%, P ؍ NS), and total MI/stroke/mortality rate (3.9% vs 5.3%, P ؍ NS). Conclusions: The data in this study demonstrate that high-risk patients undergoing CAS had comparable outcomes to low-risk patients undergoing CEA. This study supports the use of CAS as a reasonable alternative for patients at increased perioperative risk for CEA. ( J Vasc Surg 2008;47:946-51.)