title: Carotid artery stenting and patient outcomes: the CABANA surveillance study.
abstract: OBJECTIVE
  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.
authors.affiliation: University at Buffalo, State University of New York, and Jacobs Institute, Buffalo, New York.
authors.forename: L Nelson
authors.initials: LN
authors.lastname: Hopkins
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: White
authors.forename: Malcolm T
authors.initials: MT
authors.lastname: Foster
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Powell
authors.forename: Gerald
authors.initials: G
authors.lastname: Zemel
authors.forename: Juan
authors.initials: J
authors.lastname: Diaz-Cartelle
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D058070:Asymptomatic Diseases; D016893:Carotid Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D057505:Embolic Protection Devices; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
keywords: carotid artery; carotid stenosis; embolic protection; stent; stroke