title: Protected carotid stenting in high-surgical-risk patients: the ARCHeR results.
abstract: BACKGROUND
  Carotid endarterectomy is the standard of care for most patients with severe extracranial carotid bifurcation disease. However, its safety and efficacy in patients with significant surgical risk are unclear. The ARCHeR (ACCULINK for Revascularization of Carotids in High-Risk patients) trial was performed to determine whether carotid artery stenting with embolic protection is a safe and effective alternative to endarterectomy in high-surgical-risk patients.
  
  
  METHODS
  The ARCHeR trial is a series of three sequential, multicenter, nonrandomized, prospective studies. Forty-eight sites enrolled 581 high-surgical-risk patients between May 2000 and September 2003. Patients with severe carotid artery stenosis (angiographically defined, symptomatic > or =50%, or asymptomatic > or =80%) had an ACCULINK nitinol stent implanted. The ACCUNET filter embolic protection system was added to the procedure in the final 2 studies (422 patients). The primary efficacy end point was a composite of periprocedural (< or =30 days) death, stroke, and myocardial infarction, plus ipsilateral stroke between days 31 and 365.
  
  
  RESULTS
  The 30-day rate of death/stroke/myocardial infarction was 8.3% (95% confidence interval [CI], 6.2%-10.8%), and that of stroke/death was 6.9% (95% CI, 5.0%-9.3%). Most (23/32) strokes were minor, of which more than half (12/23) returned to baseline National Institutes of Health Stroke Scale scores within 30 days. The 30-day major/fatal stroke rate was 1.5% (95% CI, 0.7%-2.9%). No hemorrhagic strokes were observed in the study. Ipsilateral cerebrovascular accident occurred in 1.3% between 30 days and 1 year, thus giving a primary composite end point of 30-day death/stroke/myocardial infarction plus ipsilateral stroke at 1 year of 9.6% (95% CI, 7.2%-12.0%), which is below the 14.4% historical control comparator. Target lesion revascularization at 12 months and 2 years was 2.2% and 2.9%, respectively.
  
  
  CONCLUSIONS
  The ARCHeR results demonstrate that extracranial carotid artery stenting with embolic filter protection is not inferior to historical results of endarterectomy and suggest that carotid artery stenting is a safe, durable, and effective alternative in high-surgical-risk patients.
authors.affiliation: Columbia University Medical Center, New York, NY 10032, USA. wg2131@columbia.edu
authors.forename: William A
authors.initials: WA
authors.lastname: Gray
authors.forename: L Nelson
authors.initials: LN
authors.lastname: Hopkins
authors.forename: Sanjay
authors.initials: S
authors.lastname: Yadav
authors.forename: Thomas
authors.initials: T
authors.lastname: Davis
authors.forename: Mark
authors.initials: M
authors.lastname: Wholey
authors.forename: Richard
authors.initials: R
authors.lastname: Atkinson
authors.forename: Alberto
authors.initials: A
authors.lastname: Cremonesi
authors.forename: Ronald
authors.initials: R
authors.lastname: Fairman
authors.forename: Gary
authors.initials: G
authors.lastname: Walker
authors.forename: Patrick
authors.initials: P
authors.lastname: Verta
authors.forename: Jeff
authors.initials: J
authors.lastname: Popma
authors.forename: Renu
authors.initials: R
authors.lastname: Virmani
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
mesh_terms: D000800:Angioplasty, Balloon / Q000379:methods*; D016893:Carotid Stenosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D002986:Clinical Trials as Topic; D016894:Endarterectomy, Carotid; D006801:Humans; D015201:Meta-Analysis as Topic; D009203:Myocardial Infarction / Q000209:etiology; D011183:Postoperative Complications; D015607:Stents; D020521:Stroke / Q000209:etiology; D016019:Survival Analysis; D016306:Vena Cava Filters