title: Safety of unprotected carotid artery stent placement in symptomatic and asymptomatic patients: a retrospective analysis of 30-day combined adverse outcomes.
abstract: OBJECTIVE
  To retrospectively evaluate the outcome of carotid artery stent placement (CAS) without the use of embolic protection devices (EPDs) in a large cohort of patients.
  
  
  METHODS
  Institutional review board approval and informed consent from all patients were obtained. Preprocedure color Doppler ultrasonography (US), magnetic resonance (MR) imaging, or computed tomography (CT) were used to evaluate stenosis severity (70% or greater). Clinical findings and combined 30-day complication rates in 400 patients (289 men, 111 women; mean age, 73 years +/- 8 [standard deviation]) who underwent unprotected CAS for asymptomatic (n = 156; 39%) or symptomatic (n = 244, 61%) stenoses were analyzed. Follow-up at 30 days included neurologic evaluation and color Doppler US.
  
  
  RESULTS
  Self-expanding stents were successfully deployed in 397 of 400 (99.25%) patients. Among the 397 patients, nine (2.27%) major complications (all in patients with prior symptoms) had occurred at 30 days, including three (0.76%) major (all in patients who had stopped antiplatelet prophylaxis) and six (1.5%) minor strokes--three intraprocedural and three delayed. Minor complications included 16 (4%) transient ischemic attacks, four in asymptomatic and 12 in symptomatic patients. The 30-day combined adverse outcomes (transient ischemic attack, ipsilateral stroke, death) were significantly correlated with prior presence of symptoms (symptomatic, 8.6%; asymptomatic, 2.6%; P < .03).
  
  
  CONCLUSIONS
  Stent placement without EPD was performed with a high technical success rate. For asymptomatic patients, the combined 30-day adverse-outcomes rate was within the limits recommended by the American Heart Association for carotid endarterectomy and compared favorably with results reported for CAS with EPD. When a transient ischemic attack is excluded, the 30-day combined death and stroke rate among patients with prior symptoms also compared favorably with published results.
authors.affiliation: Department of Radiology, IRCCS Galeazzi Orthopaedic Institute, Via Riccardo Galeazzi 4, 20161 Milan, Italy. franco.perona@yahoo.it
authors.forename: Franco
authors.initials: F
authors.lastname: Perona
authors.forename: Giorgio
authors.initials: G
authors.lastname: Castellazzi
authors.forename: Luca
authors.initials: L
authors.lastname: Valvassori
authors.forename: Edoardo
authors.initials: E
authors.lastname: Boccardi
authors.forename: Laura
authors.initials: L
authors.lastname: de Girolamo
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Cornalba
authors.forename: Krishna
authors.initials: K
authors.lastname: Kandarpa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015901:Angiography, Digital Subtraction; D016893:Carotid Stenosis / Q000175:diagnosis / Q000628:therapy*; D002533:Cerebral Angiography; D004867:Equipment Design; D005260:Female; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000517:prevention & control*; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000517:prevention & control*; D008279:Magnetic Resonance Imaging; D008297:Male; D010043:Outcome and Process Assessment, Health Care; D012008:Recurrence; D012189:Retrospective Studies; D015607:Stents; D014057:Tomography, X-Ray Computed; D018615:Ultrasonography, Doppler, Color