Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China.
Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.
Am Heart J. 2020 May;223:72-80. doi: 10.1016/j.ahj.2020.02.015. Epub 2020 Feb 24.
Quantitative flow ratio (QFR) is a novel angiography-based approach enabling fast computation of fractional flow reserve without use of pressure wire or adenosine. The objective of this investigator-initiated, multicenter, patient- and clinical assessor-blinded randomized trial is to evaluate the efficacy and cost-effectiveness of a QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy for percutaneous coronary intervention (PCI) in patients with coronary artery disease.
Approximately 3,830 patients will be randomized in a 1:1 ratio to a QFR-guided or an angiography-guided strategy. Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter. Subjects assigned to the QFR-guided strategy will have QFR measured in each interrogated vessel and undergo PCI when QFR ≤0.80, with deferral for lesions with QFR >0.80. Those assigned to the angiography-guided strategy will undergo PCI based on angiography. Optimal medical therapy will be administered to all treated and deferred patients. The primary end point is the 1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization. The major secondary end point is 1-year MACE excluding periprocedural myocardial infarction. Other secondary end points include the individual components of MACE and cost-effectiveness end points. The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
The FAVOR III China study will be the first randomized trial to examine the effectiveness and cost-effectiveness of a QFR-guided versus an angiography-guided PCI strategy in coronary artery disease patients.
定量血流比（QFR）是一种新的基于血管造影的方法，可在不使用压力导丝或腺苷的情况下快速计算血流储备分数。这项由研究者发起的、多中心的、患者和临床评估者双盲随机试验的目的是评估 QFR 增强血管造影指导（QFR 指导）策略与仅血管造影指导（血管造影指导）策略在冠状动脉疾病患者中的疗效和成本效益。
大约 3830 名患者将以 1:1 的比例随机分为 QFR 指导组和血管造影指导组。纳入的受试者计划进行冠状动脉造影，至少有 1 处病变符合 PCI 标准，即狭窄程度为 50%-90%的动脉，参考直径≥2.5mm。被分配到 QFR 指导策略的受试者将在每个检查的血管中测量 QFR，并在 QFR≤0.80 时进行 PCI，对 QFR>0.80 的病变进行延迟处理。被分配到血管造影指导策略的患者将根据血管造影进行 PCI。所有接受治疗和延迟处理的患者将接受最佳的药物治疗。主要终点是 1 年时主要不良心脏事件（MACE）的发生率，复合终点包括全因死亡率、任何心肌梗死或任何缺血驱动的血运重建。主要次要终点是 1 年时不包括围手术期心肌梗死的 MACE。其他次要终点包括 MACE 的各个组成部分和成本效益终点。该样本量有 85%的效能证明 QFR 指导优于血管造影指导。
FAVOR III China 研究将是第一个随机试验，旨在检查 QFR 指导与血管造影指导的 PCI 策略在冠心病患者中的有效性和成本效益。
