Background: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.Methods: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.Results:In total, 351 CEC-adjudicated repeat revascularization events occurred, with retrospective QFR analysis successfully performed in 212 (60.4%). According to QFR analysis, 104 events (QFR ≤0.80) were adjudicated as CI revascularizations and 108 (QFR >0.80) were not. The agreement between CEC and QFR based adjudication was just fair (κ=0.335). Between the 2 methods of adjudication, there was a disagreement of 26.4% and 7.1% in CI and non-CI revascularization, respectively. Overall, the concordance and discordance rates were 66.5% and 33.5%, respectively.Conclusions: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.

中文翻译：

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随机对照试验中血运重建事件的临床裁决与基于流量的裁决的比较

背景：在临床试验中，判断有临床或非临床指征 (CI) 的血运重建事件的最佳方法是使用独立的临床事件委员会 (CEC)。然而，Academic Research Consortium-2 目前建议使用生理评估。这些裁定方法之间的一致性水平仍然未知。方法：在 TALENT 试验中随访 2 年，在 DESSOLVE III、PIONEER 和 SYNTAX 中随访 3 年的 3457 名患者中，所有 CEC 裁定血运重建事件的数据II 试验由一个对常规 CEC 裁决结果不知情的独立核心实验室根据血管重建血管的定量流量比 (QFR) 分析收集和重新裁决。κ统计量用于评估两种方法之间的一致性水平。结果：总共发生了 351 例 CEC 判定的重复血运重建事件，其中 212 例 (60.4%) 成功进行了回顾性 QFR 分析。根据 QFR 分析，104 起事件（QFR ≤0.80）被判定为 CI 血运重建，108 起（QFR >0.80）未被判定。CEC 和基于 QFR 的裁决之间的协议是公平的（κ=0.335）。在两种判定方法之间，CI 和非 CI 血运重建的分歧分别为 26.4% 和 7.1%。总体而言，一致率和不一致率分别为 66.5% 和 33.5%。结论：在该事件水平分析中，基于 QFR 的裁决与 CEC 裁决在血运重建事件是否为 CI 方面的一致性相对较低。与 QFR 裁决相比，CEC 裁决似乎高估了 CI 血运重建。在未来的试验中，有必要在血运重建裁决方面直接比较这两种策略。注册：URL：https://www.clinicaltrials.gov；唯一标识符：TALENT 试验：NCT02870140，DESSOLVE III 试验：NCT02385279，SYNTAX II：NCT02015832，PIONEER 试验：NCT02236975。