title: Carotid stenting with distal protection in high-surgical-risk patients: one-year results of the ASTI trial.
abstract: OBJECTIVE
  This prospective, multicenter, nonrandomized study evaluated the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt Carotid Stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation, Natick, MA).
  
  
  METHODS
  The study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid endarterectomy due to prespecified anatomical criteria and/or medical comorbidities. Thirty-day and 1-year follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments. One-year endpoints included the composite rate of major adverse events (MAE), defined as death, stroke, and myocardial infarction (MI) and the rates of late ipsilateral stroke (31-365 days), target lesion revascularization, and in-stent restenosis.
  
  
  RESULTS
  Of the 100 enrolled patients, technical success was achieved in 90.9 % (90/99). The 30-day MAE rate (5.1 %) consisted of major stroke (2.0 %) and minor stroke (3.1 %); no deaths or MIs occurred. The 1-year MAE rate (12.2 %) consisted of death, MI, and stroke rates of 4.4, 3.3, and 8.9 %, respectively. Late ipsilateral stroke (31-365 days) rate was 1.1 %. Symptomatic patients had higher rates of death (11.1 vs. 1.7 %) and MI (7.4 vs. 1.7 %), but lower rates of major (7.4 vs. 10.0 %) and minor stroke (0.0 vs. 6.7 %), compared with asymptomatic patients.
  
  
  CONCLUSIONS
  Results through 1 year postprocedure demonstrated that carotid artery stenting with Adapt Carotid Stent and FilterWire EZ is safe and effective in high-risk-surgical patients.
authors.affiliation: Department of Vascular Surgery, A.Z. Sint-Blasius, Kroonveldlaan 50, 9200, Dendermonde, Belgium, marc.bosiers@telenet.be.
authors.forename: Marc
authors.initials: M
authors.lastname: Bosiers
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Klaus
authors.initials: K
authors.lastname: Mathias
authors.forename: Ralf
authors.initials: R
authors.lastname: Langhoff
authors.forename: Harald
authors.initials: H
authors.lastname: Mudra
authors.forename: Juan
authors.initials: J
authors.lastname: Diaz-Cartelle
mesh_terms: D000368:Aged; D001530:Belgium / Q000453:epidemiology; D016893:Carotid Stenosis / Q000453:epidemiology / Q000628:therapy*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000453:epidemiology; D011446:Prospective Studies; D018570:Risk Assessment; D013030:Spain / Q000453:epidemiology; D015607:Stents; D020521:Stroke / Q000453:epidemiology; D016896:Treatment Outcome