title: Carotid artery stenting with emboli protection surveillance study: outcomes at 1 year.
abstract: OBJECTIVE
  The CASES-PMS (Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study) multicenter, prospective, single-arm, surveillance study was designed to assess the safety and efficacy of carotid artery stenting (CAS) when performed by physicians with varied experience in CAS utilizing a formal training program. Whether the excellent results achieved at 30 days would be sustained to 1 year was the subject of the current investigation.
  
  
  BACKGROUND
  Previously, the pivotal SAPPHIRE (Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy) trial demonstrated that CAS was not inferior to carotid endarterectomy (CEA) when performed by physicians experienced in carotid stenting.
  
  
  METHODS
  High surgical-risk patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in native carotid arteries were enrolled at participating centers. Inclusion and exclusion criteria matched those of the SAPPHIRE trial. The primary end point was a composite of 30-day major adverse events (MAE) including death, any stroke, or myocardial infarction.
  
  
  RESULTS
  A total of 1,492 patients were enrolled at 73 sites. The primary end point of 30-day MAE was 5.0%, meeting criteria for noninferiority to the prespecified objective performance criteria (OPC) established by the SAPPHIRE trial. The 1-year cumulative percentage of MAE was 12.5% by Kaplan-Meier analysis. All strokes to 30 days plus ipsilateral stroke between 31 and 360 days with CASES-PMS (5.4%) was similar to the rate seen with the SAPPHIRE trial stent cohort (4.9%). There were no significant differences in outcomes at 1 year by symptom status and high-risk status.
  
  
  CONCLUSIONS
  With the formalized training program utilized in this study, physicians with varied experience in carotid stenting can achieve similar short- and longer-term results to the highly experienced SAPPHIRE Investigators. (Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study [CASES-PMS]; NCT00231231).
authors.affiliation: Harper University Hospital, Detroit, Michigan, USA. tschreib@dmc.org
authors.forename: Theodore L
authors.initials: TL
authors.lastname: Schreiber
authors.forename: Neil
authors.initials: N
authors.lastname: Strickman
authors.forename: Thomas
authors.initials: T
authors.lastname: Davis
authors.forename: Vinay
authors.initials: V
authors.lastname: Kumar
authors.forename: Greg
authors.initials: G
authors.lastname: Mishkel
authors.forename: Malcolm
authors.initials: M
authors.lastname: Foster
authors.forename: Dennis
authors.initials: D
authors.lastname: Donohoe
authors.forename: Suzanne
authors.initials: S
authors.lastname: Britto
authors.forename: Gary
authors.initials: G
authors.lastname: Ansel
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002339:Carotid Arteries; D002340:Carotid Artery Diseases / Q000517:prevention & control*; D016893:Carotid Stenosis / Q000628:therapy; D002983:Clinical Competence; D004617:Embolism / Q000517:prevention & control*; D016894:Endarterectomy, Carotid; D005260:Female; D006801:Humans; D008297:Male; D010043:Outcome and Process Assessment, Health Care; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome