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  • Popma, Christopher J.Beth Israel Deaconess Med Ctr, Dept Med, Div Cardiol, Boston, MA 02215 USA. (author)

Lack of Concordance Between Local Investigators, Angiographic Core Laboratory, and Clinical Event Committee in the Assessment of Stent Thrombosis Results From the TRACER Angiographic Substudy

  • Article/chapterEnglish2016

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  • 2016
  • printrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:uu-298907
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-298907URI
  • https://doi.org/10.1161/CIRCINTERVENTIONS.115.003114DOI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Background-Stent thrombosis (ST) is an important end point in cardiovascular clinical trials. Adjudication is traditionally based on clinical event committee (CEC) review of case report forms and source documentation rather than angiograms. However, the degree to which this method of adjudication is concordant with the review of independent angiographic core laboratories (ACLs) has not been studied. This report represents the first assessment of variability between local investigators (LIs), a CEC, and an ACL. Methods and Results-Serial angiograms of 329 patients with acute coronary syndrome without ST-segment-elevation who underwent percutaneous coronary intervention at entry in the Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRACER) and who met criteria for possible ST subsequent to the index event were reviewed by an ACL. The ACL was blinded to the assessment by both LIs and the CEC regarding the presence or absence of ST. CEC adjudication was based on Academic Research Consortium definitions of ST, using case report form data and source documents, including catheterization laboratory reports. The ACL, CEC, and LIs agreed on the presence or absence of ST in 52.9% events (kappa=0.32; 95% confidence interval, 0.26-0.39). The ACL and CEC agreed on 82.7% of events (kappa=0.57; 95% confidence interval, 0.47-0.67); the ACL and LIs agreed on 61.1% of events (kappa=0.25; 95% confidence interval, 0.16-0.34); and the CEC and LIs agreed on 62% of events (kappa=0.28; 95% confidence interval, 0.21-0.36). Conclusions-ST reporting by an ACL, a CEC, and LIs is discordant. The assessment of ST is more often detected by direct review of angiograms by an ACL.

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Added entries (persons, corporate bodies, meetings, titles ...)

  • Sheng, ShiHuazhong Univ Sci & Technol, Tongji Med Coll, Dept Vasc Surg, Union Hosp, Wuhan 430074, Peoples R China. (author)
  • Korjian, SergeBeth Israel Deaconess Med Ctr, Dept Med, Div Cardiol, Boston, MA 02215 USA. (author)
  • Daaboul, YazanBeth Israel Deaconess Med Ctr, Dept Med, Div Cardiol, Boston, MA 02215 USA. (author)
  • Chi, GeraldBeth Israel Deaconess Med Ctr, Dept Med, Div Cardiol, Boston, MA 02215 USA. (author)
  • Tricoci, PierluigiDuke Clin Res Inst, Durham, NC USA. (author)
  • Huang, ZhenDuke Clin Res Inst, Durham, NC USA. (author)
  • Moliterno, David J.Univ Kentucky, Dept Med, Gill Heart Inst, Lexington, KY 40506 USA. (author)
  • White, Harvey D.Auckland City Hosp, Green Lane Cardiovasc Serv, Dept Cardiol, Auckland, New Zealand. (author)
  • Van de Werf, FransUniv Leuven, Dept Cardiol, Leuven, Belgium. (author)
  • Harrington, Robert A.Stanford Univ, Dept Med, Stanford, CA 94305 USA. (author)
  • Wallentin, LarsUppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi(Swepub:uu)larswall (author)
  • Held, ClaesUppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi,Klinisk psykologi i hälso- och sjukvård(Swepub:uu)clahe947 (author)
  • Armstrong, Paul W.Univ Alberta, Dept Med, Div Cardiol, Edmonton, AB, Canada. (author)
  • Aylward, Philip E.Flinders Univ & Med Ctr, Cardiac & Crit Care Serv, Dept Med, South Australian Hlth & Med Res Inst, Adelaide, SA, Australia. (author)
  • Strony, JohnMerck & Co Inc, Merck Clin Res, Whitehouse Stn, NJ USA. (author)
  • Mahaffey, Kenneth W.Stanford Univ, Dept Med, Stanford, CA 94305 USA. (author)
  • Gibson, C. MichaelBeth Israel Deaconess Med Ctr, Dept Med, Div Cardiol, Boston, MA 02215 USA. (author)
  • Beth Israel Deaconess Med Ctr, Dept Med, Div Cardiol, Boston, MA 02215 USA.Huazhong Univ Sci & Technol, Tongji Med Coll, Dept Vasc Surg, Union Hosp, Wuhan 430074, Peoples R China. (creator_code:org_t)

Related titles

  • In:Circulation. Cardiovascular Interventions9:51941-76401941-7632

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