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Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials.

Rutao WangHideyuki KawashimaHironori HaraChao GaoMasafumi OnoKuniaki TakahashiShengxian TuJuan Carlos ParodiScot GargRobert Jan van GeunsLing TaoWilliam WijnsYoshinobu OnumaPatrick W J C Serruys
Published in: Circulation. Cardiovascular quality and outcomes (2021)
In this event-level analysis, QFR based adjudication had a relatively low agreement with CEC adjudication with respect to whether revascularization events were CI or not. CEC adjudication appears to overestimate CI revascularization as compared with QFR adjudication. Direct comparison between these 2 strategies in terms of revascularization adjudication is warranted in future trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: TALENT trial: NCT02870140, DESSOLVE III trial: NCT02385279, SYNTAX II: NCT02015832, and PIONEER trial: NCT02236975.
Keyphrases
  • percutaneous coronary intervention
  • coronary artery bypass grafting
  • study protocol
  • phase iii
  • phase ii
  • clinical trial
  • randomized controlled trial
  • open label
  • systematic review
  • data analysis