title: Covered versus bare self-expanding stents for endovascular treatment of carotid artery stenosis: a stopped randomized trial.
abstract: OBJECTIVE
  To investigate whether filter-protected carotid artery stenting (CAS) using a covered self-expanding stent reduces the risk of cerebral embolization.
  
  
  METHODS
  Fourteen asymptomatic patients (13 men; median age 77 years, IQR 73-83) were enrolled in a randomized pilot trial comparing the rates of cerebral microembolism during and after filter-protected CAS using either a self-expanding covered (n=8) or a bare (n=6) carotid stent. Transcranial Doppler (TCD) monitoring was done during and for 90 minutes after the procedure. Diffusion-weighted magnetic resonance imaging (DW-MRI) was performed before and 24 hours after CAS. Patients were followed for 6 months for neurological events and occurrence of restenosis.
  
  
  RESULTS
  A significant reduction in ipsilateral microembolic signals by TCD was observed with the covered (median 1, IQR 0-4) versus the bare stent (median 6, IQR 3-8; p=0.043). Comparison of the preprocedural and 24-hour postprocedural DW-MRI images showed no new ipsilateral lesions but 1 new lesion in the contralateral hemisphere in the covered stent group, resulting in an overall 7% (95% CI 0%-20%) rate of new ischemic lesions. No neurological complications occurred up to 6 months. Restenosis (>70%) occurred in 3 (38%) of 8 patients with the covered versus none of the bare stents (p=0.21). The trial was stopped when the third restenosis of a covered stent was detected.
  
  
  CONCLUSIONS
  Self-expanding covered stents potentially reduce the risk of cerebral microembolism during and after carotid stenting. However, the problem of in-stent restenosis has to be resolved before these devices can be considered for further investigation.
authors.affiliation: Department of Angiology, Vienna Medical University, Viennia, Austria. martin.schillinger@meduniwien.ac.at
authors.forename: Martin
authors.initials: M
authors.lastname: Schillinger
authors.forename: Petra
authors.initials: P
authors.lastname: Dick
authors.forename: Gerald
authors.initials: G
authors.lastname: Wiest
authors.forename: Stephan
authors.initials: S
authors.lastname: Gentzsch
authors.forename: Schila
authors.initials: S
authors.lastname: Sabeti
authors.forename: Markus
authors.initials: M
authors.lastname: Haumer
authors.forename: Andrea
authors.initials: A
authors.lastname: Willfort
authors.forename: Christian
authors.initials: C
authors.lastname: Nasel
authors.forename: Christian
authors.initials: C
authors.lastname: Wöber
authors.forename: Josef
authors.initials: J
authors.lastname: Zeitlhofer
authors.forename: Erich
authors.initials: E
authors.lastname: Minar
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects*; D002343:Carotid Artery, Internal / Q000000981:diagnostic imaging; D016893:Carotid Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D038524:Diffusion Magnetic Resonance Imaging; D005260:Female; D006083:Graft Occlusion, Vascular / Q000175:diagnosis*; D006801:Humans; D020766:Intracranial Embolism / Q000000981:diagnostic imaging / Q000209:etiology*; D008297:Male; D010865:Pilot Projects; D011183:Postoperative Complications; D015607:Stents / Q000009:adverse effects*; D017585:Ultrasonography, Doppler, Transcranial