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Published on: September 14, 2009
Autopsy validation study of the academic research consortium stent thrombosis definition
Donald E Cutlip1, Gaku Nakazawa, Mitchell W Krucoff
1Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, USA. dcutlip@bidmc.harvard.edu
Insights
The Academic Research Consortium (ARC) criteria for stent thrombosis have poor sensitivity when strictly applied. Modifying the "possible" classification improves accuracy for late stent thrombosis detection in autopsy studies.
Area of Science:
- Cardiovascular Research
- Pathology
- Medical Device Analysis
Background:
- The Academic Research Consortium (ARC) criteria are widely used for classifying stent thrombosis.
- Validation of ARC criteria against autopsy findings is lacking.
Purpose of the Study:
- To validate the sensitivity and specificity of ARC stent thrombosis classification.
- To compare clinical adjudication with autopsy-confirmed stent thrombosis.
Main Methods:
- Utilized an autopsy registry of 139 patients with coronary stents.
- Performed histopathological analysis for stent thrombosis confirmation.
- Adjudicated cases using ARC criteria, including a modified 'possible' classification for late deaths.
Main Results:
- Autopsy confirmed 51 cases of stent thrombosis.
- Definite and definite plus probable ARC criteria showed high specificity but low sensitivity.
- Including the modified 'possible' classification significantly improved sensitivity to 92% but decreased specificity to 34%.
Conclusions:
- Strict ARC criteria (definite/probable) under-report confirmed stent thrombosis cases.
- A modified 'possible' classification may better estimate late and very late stent thrombosis rates.
- Autopsy validation highlights limitations in current clinical classifications.
Objectives:
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.
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