22Oct 2021
Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials

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

In clinical trials, the optimal method of adjudicating revascularization events as clinically or nonclinically indicated (CI) is to use an independent Clinical Events Committee (CEC). However, the Academic Research Consortium-2 currently recommends using physiological assessment. The level of agreement between these methods of adjudication remains unknown. Data for all CEC adjudicated revascularization events among the 3457 patients followed-up for 2-years in the TALENT trial, and 3-years in the DESSOLVE III, PIONEER, and SYNTAX II trial were collected and readjudicated according to a quantitative flow ratio (QFR) analysis of the revascularized vessels, by an independent core lab blinded to the results of the conventional CEC adjudication. The κ statistic was used to assess the level of agreement between the 2 methods...

  • #cardiology

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