TY - JOUR
T1 - Quality Assurance for Carotid Stenting in the CREST-2 Registry
AU - Lal, Brajesh K.
AU - Roubin, Gary S.
AU - Rosenfield, Kenneth
AU - Heck, Donald
AU - Jones, Michael
AU - Jankowitz, Brian
AU - Jovin, Tudor
AU - Chaturvedi, Seemant
AU - Dabus, Guilherme
AU - White, Christopher J.
AU - Gray, William
AU - Matsumura, Jon
AU - Katzen, Barry T.
AU - Hopkins, L. Nelson
AU - Mayorga-Carlin, Minerva
AU - Sorkin, John D.
AU - Howard, George
AU - Meschia, James F.
AU - Brott, Thomas G.
N1 - Funding Information:
The authors acknowledge the contributions of the Earl & Nyda Swanson Neurosciences Research Fund and the Harley N. and Rebecca N. Hotchkiss Endowed Fund in Neuroscience Research, Honoring Ken and Marietta. The CREST-2 trial is funded by the National Institute of Neurological Disorders and Stroke (NINDS) through 2 U01 awards: U01 NS080168 and U01 NS08016; the CREST-2 registry is funded by NINDS–National Institutes of Health and by Abbott Vascular, Boston Scientific, Cordis-Cardinal, W. L. Gore and Associates, Medtronic, and Silk Road Medical. Dr. Roubin has received royalties from Cook Medical; and holds equity in Essential Medical. Dr. Rosenfield has served on Scientific Advisory Boards or as a consultant for Abbott Vascular, Access Vascular, BTG, Eximo, Volcano-Philips, Surmodics, Shockwave, Cruzar, Capture Vascular, Endospan, Magneto, MD Insider, Micell, Silk Road, Summa Therapeutics, Valcare, Thrombolex, and the University of Maryland; has received research grants from the National Institutes of Health and Boston Scientific; and holds equity in Access Closure, Access Vascular, Contego, Endospan, Embolitech, Eximo, JanaCare, PQ Bypass, Primacea, MD Insider, Shockwave, Silk Road, Summa Therapeutics, Cruzar Systems, Capture Vascular, Magneto, Micell, and Valcare. Dr. Heck has served as a consultant for Stryker. Dr. Jones has served as a speaker for Abbott Vascular. Dr. Jankowitz has served as a consultant for Medtronic and Stryker. Dr. Chaturvedi has received grant support from Boehringer Ingelheim. Dr. Dabus has received consulting honoraria from Medtronic and Microvention. Dr. Gray has served as a consultant for Abbott Vascular, Boston Scientific, and Medtronic. Dr. Matsumura has received grants from Abbott, W. L. Gore, Cook, Medtronic, and Endologix. Dr. Katzen has served on Advisory Boards for Boston Scientific, Philips Healthcare, and W. L. Gore. Dr. Hopkins has served as a consultant for Boston Scientific, Imperative Care, Cerebrotech, Silk Road, Endostream, and OstialNextgen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2019 American College of Cardiology Foundation
PY - 2019/12/24
Y1 - 2019/12/24
N2 - 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.
AB - 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.
KW - asymptomatic
KW - carotid
KW - registry
KW - stenosis
KW - stenting
KW - symptomatic
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U2 - 10.1016/j.jacc.2019.10.032
DO - 10.1016/j.jacc.2019.10.032
M3 - Article
C2 - 31856962
AN - SCOPUS:85076036316
SN - 0735-1097
VL - 74
SP - 3071
EP - 3079
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 25
ER -