Diagnostic Agreement and Threshold Correspondence Between Resting Full-Cycle Ratio and Nicorandil-Based Fractional Flow Reserve in Intermediate Coronary Stenosis: A Prospective Single-Center Registry.

Yonghoon Shin, Onyou Kim, Gi Won Yu, Yun Won Lee, Jung-Joon Cha, Hyung Joon Joo, Jae Hyoung Park, Soon Jun Hong, Cheol Woong Yu
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Abstract

Background: RFR has shown good aggregate agreement with FFR, including in prior Asian cohorts using intracoronary nicorandil. Where RFR-FFR disagreement is concentrated relative to the FFR 0.80 decision boundary, and how the two binary thresholds correspond, remain incompletely characterized.

Methods: In a prospective single-center registry, 300 patients (399 lesions) underwent sequential RFR and nicorandil-based FFR measurement. Diagnostic accuracy was assessed with patient-level cluster bootstrap CIs across post hoc FFR and RFR strata. Threshold correspondence used ordinary least squares and Deming regression. Univariable logistic regression evaluated correlates of discordance (exploratory).

Results: Overall threshold-based agreement was 85.0% (95% CI 81.1%-88.5%; κ = 0.684) with AUC 0.932 (95% CI 0.906-0.954). RFR exceeded FFR by +0.067 (patient-mean limits of agreement -0.040 to +0.173). Agreement was 91.6-92.8% away from the FFR 0.80 decision boundary but 72.0-73.5% in the two flanking strata. RFR 0.89 corresponded to an FFR of approximately 0.823, similar with Deming regression. Agreement exceeded 92% outside RFR 0.87-0.91 but was 63.2% within this exploratory band and 68.8% within the 0.86-0.92 interval of previous hybrid strategies. LAD territory was an exploratory univariable correlate of discordance, which likely reflected the FFR distribution of LAD lesions.

Conclusions: RFR showed high agreement with nicorandil-based FFR, consistent with prior cohorts. Disagreement was concentrated near the FFR decision boundary, as expected for two correlated continuous indices dichotomized at fixed thresholds, and this study quantifies its frequency. Agreement was lowest near the RFR cut-off (0.87-0.91), an exploratory interval that overlaps with previous hybrid gray zones and requires validation in outcome studies.

中级冠状动脉狭窄的静息全周期比值和尼可地尔血流储备分数的诊断一致性和阈值对应:一项前瞻性单中心注册研究。
背景:RFR与FFR总体上表现出良好的一致性,包括先前使用冠状动脉内尼可地尔的亚洲队列。相对于FFR 0.80决策边界,RFR-FFR分歧集中在哪里,以及两个二值阈值如何对应,仍然没有完全表征。方法:在前瞻性单中心注册中,300例患者(399个病变)接受了顺序RFR和基于尼可地尔的FFR测量。诊断准确性通过患者水平的聚类自举CIs在事后FFR和RFR层进行评估。阈值对应采用普通最小二乘法和Deming回归。单变量逻辑回归评估了不一致的相关性(探索性)。结果:基于阈值的总体一致性为85.0% (95% CI 81.1%-88.5%; κ = 0.684), AUC为0.932 (95% CI 0.906-0.954)。RFR超过FFR +0.067(患者-平均一致限为-0.040至+0.173)。与FFR 0.80决定边界的一致性为91.6-92.8%,但与两侧地层的一致性为72.0-73.5%。RFR 0.89对应FFR约为0.823,与Deming回归相似。在RFR 0.87-0.91之外,一致性超过92%,但在该探索区间内,一致性为63.2%,在先前混合策略的0.86-0.92区间内,一致性为68.8%。LAD区域是不一致的探索性单变量相关,这可能反映了LAD病变的FFR分布。结论:RFR与基于尼可地尔的FFR高度一致,与先前的队列一致。分歧集中在FFR决策边界附近,正如在固定阈值处二分类的两个相关连续指标所期望的那样,本研究量化了其频率。在RFR截止点(0.87-0.91)附近,一致性最低,这是一个与之前的混合灰色地带重叠的探索性区间,需要在结果研究中进行验证。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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