title: Autopsy validation study of the academic research consortium stent thrombosis definition.
abstract: OBJECTIVE
  This study sought to validate the sensitivity and specificity of the Academic Research Consortium's (ARC) classification of stent thrombosis.
  
  
  BACKGROUND
  Classification of stent thrombosis according to ARC criteria has become widely accepted. The criteria have not been validated against an autopsy standard.
  
  
  METHODS
  An autopsy registry of 139 subjects with prior coronary stenting underwent detailed histopathological analysis to assess for stent thrombosis. Based on clinical data only, cases were adjudicated according to ARC stent thrombosis criteria, including a proposed modification of the possible classification to include death beyond 30 days due only to sudden death or acute ischemia.
  
  
  RESULTS
  Autopsy results confirmed 51 cases as positive and 88 as negative for stent thrombosis. Clinical adjudication classified 105 cases as definite (10), probable (31), or possible (64) ARC stent thrombosis. Specificity was high for definite (99%) and definite plus probable (83%) criteria, but sensitivity was poor at 18% and 51%, respectively. Including the possible cases improved sensitivity to 92% but reduced specificity to 34% (58 false positives). The modified possible criteria eliminated 13 false positive cases (specificity = 49%) and was the best approximation of a hypothetical gold standard in a sensitivity analysis if late death represented at least 20% of all stent thrombosis cases.
  
  
  CONCLUSIONS
  In a selected autopsy sample, restricting ARC stent thrombosis to definite or definite plus probable criteria results in substantial under-reporting of confirmed cases. Inclusion of a modified possible classification may provide the best estimate of late and very late stent thrombosis rates.
authors: Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, USA. dcutlip@bidmc.harvard.edu
authors: Donald E
authors: DE
authors: Cutlip
authors: Gaku
authors: G
authors: Nakazawa
authors: Mitchell W
authors: MW
authors: Krucoff
authors: Marc
authors: M
authors: Vorpahl
authors: Roxana
authors: R
authors: Mehran
authors: Aloke V
authors: AV
authors: Finn
authors: Pascal
authors: P
authors: Vranckx
authors: Carey
authors: C
authors: Kimmelstiel
authors: Clifford
authors: C
authors: Berger
authors: John L
authors: JL
authors: Petersen
authors: Theresa
authors: T
authors: Palabrica
authors: Renu
authors: R
authors: Virmani