ARC Definitions of stent thrombosis

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ARC Definitions of stent thrombosis
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Current trial protocol definitions of stent
thrombosis

• CEC process for adjudication of
  definite/confirmed ST has been the same for all
  major trials of DES
• Acute myocardial ischemia (ECG major ST
  abnormality or any biomarker elevation) AND
• Angiographic or autopsy evidence of stent
  occlusion or thrombus
• Absence of intervening TLR
• Possible/presumed ST
• MI in target vessel territory without
  angiographic evidence of thrombus or other
  culprit
• Variably reported among different devices and
  within studies of same device

Cutlip DE. Presented at Transcatheter
Cardiovascular Therapeutics October 22-27, 2006
Washington DC.
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United States and European collaborationAcademia,
industry and regulatory
Academic Research Consortium
European investigators Cardialysis Erasmus MC,
Rotterdam Bern, Switzerland Paris, France
US investigators Harvard clinical research
institute Cardiovascular research foundation Duke
clinical research institute
Industry
FDA
Washington, DC March 2006 Dublin, Ireland July
2006
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ARC definitions of stent thrombosis

• Definite Stent Thrombosis
• Angiographic or pathologic confirmation of
  partial or total thrombotic occlusion within the
  peri-stent region
• AND at least ONE of the following, additional
  criteria
• Acute ischemic symptoms
• Ischemic ECG changes
• Elevated cardiac biomarkers
• Probable Stent Thrombosis
• Any unexplained death within 30 days of stent
  implantation
• Any myocardial infarction, which is related to
  documented acute ischemia in the territory of the
  implanted stent without angiographic confirmation
  of stent thrombosis and in the absence of any
  other obvious cause
• Possible Stent Thrombosis
• Any unexplained death beyond 30 days

Cutlip D et al. Circulation. 20071152344-2351
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Time frame of ARC definitions of stent thrombosis
1 month
1 year
Late gt 1 mo 1year
Early 1 mo
Very Late gt 1year
Acute 1d
Subacute gt1d - 1mo
0 day to 1 day Acute stent thrombosis gt1 day to 1
month Subacute stent thrombosis gt1 month to 1
year Late stent thrombosis gt 1 year Very late
stent thrombosis
Cutlip D et al. Circulation. 20071152344-2351