title: A meta-analysis of proximal occlusion device outcomes in carotid artery stenting.
abstract: BACKGROUND
  The clinical risk predictors for adverse events in carotid stenting using distal embolic protection devices are well established and include patient age and symptomatic status. The risk predictors for adverse events with proximal occlusion devices are not as well established. This study is a meta-analysis of available data on proximal occlusion devices to determine the risk predictors of adverse events in carotid stenting.
  
  
  METHODS
  Study-specific results on 2,397 patients from six independent databases of two different proximal occlusion devices were meta-analyzed by an independent statistical analysis organization for predictors of 30-day major adverse clinical events including stroke, myocardial infarction, and death using random effects models. The primary endpoint was the composite of total stroke, myocardial infarction, and death at 30 days.
  
  
  RESULTS
  The incidence of stroke was 1.71%. The incidence of myocardial infarction was 0.02%. The incidence of death was 0.40%. The composite primary endpoint at 30 days was 2.25%. Age and diabetic status were found to be the only significant independent risk predictors; however, total stroke rates remained below 2.6% in all subgroups, including symptomatic octogenarians. The other baseline demographic variables including patient gender, symptomatic status, and contralateral carotid occlusion were not found to be independent risk predictors.
  
  
  CONCLUSIONS
  A meta-analysis of CAS procedures performed with proximal occlusion devices demonstrated a very low incidence of adverse events at 30 days. The only independent risk predictors were age and diabetes. Patient gender, symptomatic status, and other baseline characteristics were not found to be risk predictors for CAS using proximal occlusion devices.
authors.affiliation: Department of Cardiology, Swedish Medical Center, Seattle, Washington, USA. robert.bersin@swedish.org
authors.forename: Robert M
authors.initials: RM
authors.lastname: Bersin
authors.forename: Eugenio
authors.initials: E
authors.lastname: Stabile
authors.forename: Gary M
authors.initials: GM
authors.lastname: Ansel
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Clair
authors.forename: Alberto
authors.initials: A
authors.lastname: Cremonesi
authors.forename: L Nelson
authors.initials: LN
authors.lastname: Hopkins
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Nikas
authors.forename: Bernhard
authors.initials: B
authors.lastname: Reimers
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Paolo
authors.initials: P
authors.lastname: Rubino
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002340:Carotid Artery Diseases / Q000401:mortality / Q000628:therapy*; D002561:Cerebrovascular Disorders / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D002986:Clinical Trials as Topic; D015897:Comorbidity; D016208:Databases, Factual; D003920:Diabetes Mellitus / Q000453:epidemiology; D057505:Embolic Protection Devices; D005260:Female; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control; D017711:Nonlinear Dynamics; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D020521:Stroke / Q000453:epidemiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome