Author + information
- Received June 17, 2019
- Revision received October 3, 2019
- Accepted October 15, 2019
- Published online December 16, 2019.
- Brajesh K. Lal, MDa,∗ (, )@MarylandSurgery,
- Gary S. Roubin, MD, PhDb,
- Kenneth Rosenfield, MDc,
- Donald Heck, MDd,
- Michael Jones, MDe,
- Brian Jankowitz, MDf,
- Tudor Jovin, MDg,
- Seemant Chaturvedi, MDh,
- Guilherme Dabus, MDi,
- Christopher J. White, MDj,
- William Gray, MDk,
- Jon Matsumura, MDl,
- Barry T. Katzen, MDm,
- L. Nelson Hopkins, MDn,
- Minerva Mayorga-Carlin, MPHa,
- John D. Sorkin, MD, PhDo,
- George Howard, DrPHp,
- James F. Meschia, MDq and
- Thomas G. Brott, MDq
- aDepartment of Vascular Surgery, University of Maryland, Baltimore, Maryland
- bDepartment of Cardiology, Cardiovascular Associates of the Southeast/Brookwood Baptist Medical Center, Birmingham, Alabama
- cDepartment of Cardiology, Massachusetts General Hospital, Boston, Massachusetts
- dDepartment of Radiology, Novant Health Clinical Research, Winston-Salem, North Carolina
- eDepartment of Cardiology, Baptist Health Lexington, Lexington, Kentucky
- fDepartment of Neurosurgery, UPMC Presbyterian University Hospital, Pittsburgh, Pennsylvania
- gDepartment of Neurology, UPMC Presbyterian University Hospital, Pittsburgh, Pennsylvania
- hDepartment of Neurology, University of Maryland, Baltimore, Maryland
- iDepartment of Interventional Neuroradiology, Miami Cardiac and Vascular Institute at Baptist Hospital of Miami, Miami, Florida
- jDepartment of Cardiology, Ochsner Health System, New Orleans, Louisiana
- kDepartment of Cardiology, Lankenau Medical Center, Wynnewood, Pennsylvania
- lDepartment of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin
- mDepartment of Interventional Radiology, Miami Cardiac and Vascular Institute, Miami, Florida
- nDepartment of Neurosurgery, SUNY Buffalo, Buffalo, New York
- oDepartment of Biostatistics and Informatics, Baltimore VA Medical Center, Baltimore, Maryland
- pDepartment of Biostatistics, University of Alabama at Birmingham, Birmingham, Alabama
- qDepartment of Neurology, Mayo Clinic, Jacksonville, Florida
- ↵∗Address for correspondence:
Dr. Brajesh K. Lal, 22 South Green Street, S10-B00, Baltimore, Maryland 21201.
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.
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.
- Received June 17, 2019.
- Revision received October 3, 2019.
- Accepted October 15, 2019.
- 2019 American College of Cardiology Foundation
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