Amsterdam UMC-location AMC, Department of Cardiology, University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.
Amsterdam UMC-location AMC, Department of Biomedical Engineering and Physics, Amsterdam, the Netherlands.
Am Heart J. 2020 Apr;222:139-146. doi: 10.1016/j.ahj.2019.08.018. Epub 2019 Sep 1.
It remains uncertain if invasive coronary physiology beyond fractional flow reserve (FFR) can refine lesion selection for revascularization or provide additional prognostic value. Coronary flow reserve (CFR) equals the ratio of hyperemic to baseline flow velocity and has a wealth of invasive and noninvasive data supporting its validity. Because of fundamental physiologic relationships, binary classification of FFR and CFR disagrees in approximately 30%-40% of cases. Optimal management of these discordant cases requires further study.
The aim of the study was to determine the prognostic value of combined FFR and CFR measurements to predict the 24-month rate of major adverse cardiac events. Secondary end points include repeatability of FFR and CFR, angina burden, and the percentage of successful FFR/CFR measurements which will not be excluded by the core laboratory.
This prospective, nonblinded, nonrandomized, and multicenter study enrolled 455 subjects from 12 sites in Europe and Japan. Patients underwent physiologic lesion assessment using the 0.014" Philips Volcano ComboWire XT that provides simultaneous pressure and Doppler velocity sensors. Intermediate coronary lesions received only medical treatment unless both FFR (≤0.8) and CFR (<2.0) were below thresholds. The primary outcome is a 24-month composite of death from any cause, myocardial infarction, and revascularization.
The DEFINE-FLOW study will determine the prognostic value of invasive CFR assessment when measured simultaneously with FFR, with a special emphasis on discordant classifications. Our hypothesis is that lesions with an intact CFR ≥ 2.0 but reduced FFR ≤ 0.8 will have a 2-year outcome with medical treatment similar to lesions with FFR> 0.80 and CFR ≥ 2.0. Enrollment has been completed, and final follow-up will occur in November 2019.
目前仍不清楚，血流储备分数（FFR）以外的有创冠状动脉生理学检查是否可以改善血运重建的病变选择，或者提供额外的预后价值。冠状动脉血流储备（CFR）等于充血状态与基础状态下血流速度的比值，有大量的有创和无创数据支持其有效性。由于基本的生理关系，FFR 和 CFR 的二分法分类在大约 30%-40%的病例中不一致。这些不一致病例的最佳处理方法需要进一步研究。
本研究旨在确定联合 FFR 和 CFR 测量值预测 24 个月主要不良心脏事件发生率的预后价值。次要终点包括 FFR 和 CFR 的可重复性、心绞痛负担以及不会被核心实验室排除的成功 FFR/CFR 测量百分比。
这项前瞻性、非盲法、非随机、多中心研究纳入了来自欧洲和日本 12 个中心的 455 名患者。患者使用 0.014"飞利浦 Volcano ComboWire XT 进行生理病变评估，该设备提供压力和多普勒速度传感器。除非 FFR（≤0.8）和 CFR（<2.0）均低于阈值，否则对中间冠状动脉病变仅给予药物治疗。主要终点是任何原因导致的死亡、心肌梗死和血运重建的 24 个月复合终点。
DEFINE-FLOW 研究将确定同时测量 FFR 时，有创 CFR 评估的预后价值，特别强调不一致的分类。我们的假设是，具有完整 CFR≥2.0 但 FFR≤0.8 的病变，与 FFR>0.80 且 CFR≥2.0 的病变相比，药物治疗的 2 年结局相似。目前已完成入组，最终随访将于 2019 年 11 月进行。
