Quality Assurance for Carotid Stenting in the CREST-2 Registry
Brajesh K. LalGary S. RoubinKenneth RosenfieldDonald HeckMichael R. JonesBrian T. JankowitzTudor G. JovinSeemant ChaturvediGuilherme DabusChristopher J. WhiteWilliam A. GrayJon S. MatsumuraBarry T. KatzenL. Nelson HopkinsMinerva Mayorga‐CarlinJohn D. SorkinGeorge HowardJames F. MeschiaThomas G. Brott
Key result
Carotid artery stenting by credentialed operators achieves a 2.0% 30-day stroke and death rate.
- n=2,141
Why the study?
To report periprocedural outcomes in a cohort undergoing carotid artery stenting for asymptomatic and symptomatic carotid stenosis under a national registry credentialing interventionists.
Does carotid artery stenting achieve low periprocedural stroke and death rates in patients with asymptomatic or symptomatic carotid stenosis?
Key Points
- This research aims to evaluate periprocedural outcomes in carotid artery stenting (CAS) for symptomatic and asymptomatic carotid stenosis patients.
- Cohort of 2,141 patients with carotid artery stenosis enrolled in the CREST-2 Registry.
- Interventionists were credentialed, focusing on experience and procedural techniques.
- Primary endpoint was a composite of stroke and death within 30 days; secondary outcomes included myocardial infarction and access-site complications.
- 30-day stroke and death rates were 1.4% for asymptomatic, 2.8% for symptomatic, and 2.0% overall.
- CAS procedures performed by 187 interventionists across 98 sites with a diverse patient demographic.
- Use of U.S. FDA-approved stents and embolic protection devices contributed to low complication rates.
Study Design
Type
Observational (n=2,141)
Multicenter
Yes
Structured PICO
Does carotid artery stenting achieve low periprocedural stroke and death rates in patients with asymptomatic or symptomatic carotid stenosis?
P
Population
2,141 patients (2,219 procedures) with primary atherosclerosis, asymptomatic (≥70% stenosis) or symptomatic (≥50% stenosis), ≤80 years of age, and at standard or high risk for carotid endarterectomy. Mean age 68 years, 65% male, 92% white.
I
Intervention
Carotid artery stenting (CAS)
O
Outcome
Composite of stroke and death (S/D) in the 30-day periprocedural periodcomposite
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“It is reassuring that when the trial results come out we will be dealing with probably the best possible transfemoral stenting outcomes that can be achieved.”
“The findings represent the lowest 30-day stroke or death rates that have ever been reported in the carotid stenting published research.”
Implication
Carotid artery stenting performed by credentialed operators in a national registry achieved very low 30-day periprocedural stroke and death rates (2.0% overall).
Abstract
BACKGROUND The CREST-2 Registry (C2R) was approved by National Institute of Neurological Disorders and Stroke-National Institutes of Health in September 2014 with Centers for Medicare & Medicaid Services, U.S. Food and Drug Administration, and industry collaboration to enroll patients undergoing CAS. The registry credentials interventionists and promotes optimal patient selection, procedural-technique, and outcomes. OBJECTIVES This study reports periprocedural outcomes in a cohort of carotid artery stenting (CAS) performed for asymptomatic and symptomatic carotid stenosis. METHODS Asymptomatic patients with ≥70% and symptomatic patients with ≥50% carotid stenosis, ≤80 years of age, and at standard or high risk for carotid endarterectomy are eligible for enrollment. Interventionists are credentialed by a multispecialty committee that reviews experience, lesion selection, technique, and outcomes. The primary endpoint was a composite of stroke and death (S/D) in the 30-day periprocedural period. Myocardial infarction and access-site complications were assessed as secondary outcomes. RESULTS As of December 2018, 187 interventionists from 98 sites in the United States performed 2,219 CAS procedures in 2,141 patients with primary atherosclerosis (78 were bilateral). The mean age of the cohort was 68 years, 65% were male, and 92% were white; 1,180 (55%) were for asymptomatic disease, and 961 (45%) were for symptomatic disease. All U.S. Food and Drug Administration-approved stents and embolic protection devices were represented. The 30-day rate of S/D was 1.4% for asymptomatic, 2.8% for symptomatic, and 2.0% for all patients. CONCLUSIONS C2R is the first national registry for CAS cosponsored by federal and industry partners. CAS was performed by experienced operators using appropriate patient selection and optimal technique. In that setting, a broad group of interventionists achieved very low periprocedural S/D rates for asymptomatic and symptomatic patients.
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Cite This Study
Lal et al. (2019) conducted an observational in Asymptomatic and symptomatic carotid stenosis (n=2,141). Carotid artery stenting (CAS) was evaluated on Composite of stroke and death (S/D) in the 30-day periprocedural period. Carotid artery stenting performed by credentialed operators in the CREST-2 Registry achieved a 30-day stroke and death rate of 2.0% overall (1.4% asymptomatic, 2.8% symptomatic).