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Lack of Concordance Between Local Investigators, Angiographic Core Laboratory, and Clinical Event Committee in the

Christopher J Popma1, Shi Sheng1, Serge Korjian1

  • 1From the Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (C.J.P., S.K., Y.D., G.C., C.M.G.); Department of Vascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (S.S.); Duke Clinical Research Institute, Durham, NC (P.T., Z.H.); Department of Medicine, Gill Heart Institute, University of Kentucky, Lexington (D.J.M.); Department of Cardiology, Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); Department of Cardiology, University of Leuven, Leuven, Belgium (F.V.d.W.); Department of Medicine, Stanford University, CA (R.A.H., K.W.M.); Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (L.W., C.H.); Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Canada (P.W.A.); Cardiac and Critical Care Services, Department of Medicine, South Australian Health and Medical Research Institute, Flinders University and Medical Centre, Adelaide, Australia (P.E.A.); and Merck Clinical Research, Merck & Co, Whitehouse Station, NJ (J.S.).

Circulation. Cardiovascular Interventions
|May 11, 2016
PubMed

Insights

Stent thrombosis adjudication varies significantly between local investigators, clinical event committees, and angiographic core laboratories. Direct angiogram review by core laboratories more frequently detects stent thrombosis.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Medical Imaging

Background:

  • Stent thrombosis (ST) is a critical endpoint in cardiovascular trials.
  • Traditional ST adjudication relies on clinical event committee (CEC) review, not angiograms.
  • Variability in ST assessment between different review methods is unstudied.

Purpose of the Study:

  • To assess the concordance of stent thrombosis (ST) adjudication among local investigators (LIs), a clinical event committee (CEC), and an independent angiographic core laboratory (ACL).

Main Methods:

  • Serial angiograms from 329 patients in the TRACER trial with possible ST were reviewed by an ACL.
  • The ACL was blinded to LI and CEC assessments.
  • CEC adjudication used Academic Research Consortium definitions based on case report forms and source documents.

Main Results:

  • Overall agreement on ST presence/absence among ACL, CEC, and LIs was low (52.9%, κ=0.32).
  • Agreement between ACL and CEC was higher (82.7%, κ=0.57).
  • Agreement between ACL and LIs (61.1%) and CEC and LIs (62%) was also limited.

Conclusions:

  • Stent thrombosis reporting is discordant among ACL, CEC, and LIs.
  • Angiographic core laboratory review of angiograms detects ST more often.
Abstract

Keywords:
angiographyclinical trialinterobserver variabilitystentthrombosis

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