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Carotid artery stenting and patient outcomes: The CABANA surveillance study
Author(s) -
Hopkins L. Nelson,
White Christopher J.,
Foster Malcolm T.,
Powell Richard J.,
Zemel Gerald,
DiazCartelle Juan
Publication year - 2014
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.25578
Subject(s) - medicine , carotid endarterectomy , stroke (engine) , stenosis , carotid stenting , asymptomatic , cardiology , myocardial infarction , mortality rate , clinical endpoint , prospective cohort study , surgery , clinical trial , mechanical engineering , engineering
Objectives 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. Background There is a need for additional evidence evaluating carotid artery stenting (CAS) performed by operators with various experience and training levels. Methods 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. Results Of 1,097 enrolled patients, 1,025 were evaluable for 30‐day MAE rate. The stroke rate (3.3%) was a major contributing factor in the overall MAE rate (4.6%). Mortality was 1.3% and the MI rate was 0.5%. There was no statistically significant association between MAE rates among the center experience tiers ( P = 0.61) nor among the operator training categories ( P = 0.26). Conclusions CAS with the Carotid WALLSTENT and FilterWire EZ yielded a low 30‐day MAE rate that did not differ significantly across operator experience and training levels. Clinicaltrials.gov identifier: NCT00741091. © 2014 Wiley Periodicals, Inc.