Quantitative flow ratio–guided strategy versus angiography-guided strategy for percutaneous coronary intervention: Rationale and design of the FAVOR III China trial

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 ef...

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Bibliographic Details
Published in:The American heart journal 2020-05, Vol.223, p.72-80
Main Authors: Song, Lei, Tu, Shengxian, Sun, Zhongwei, Wang, Yang, Ding, Daixin, Guan, Changdong, Xie, Lihua, Escaned, Javier, Fearon, William F., Kirtane, Ajay J., Serruys, Patrick W., Wijns, William, Windecker, Stephan, Leon, Martin B., Stone, Gregg W., Qiao, Shubin, Xu, Bo
Format: Article
Language:English
Subjects:
Accuracy
Adenosine
Angina pectoris
Angiography
Angioplasty
Approximation
Blood vessels
Cardiovascular disease
Clinical outcomes
Clinical trials
Coronary Angiography
Coronary artery
Coronary artery disease
Coronary Artery Disease - diagnostic imaging
Coronary Artery Disease - physiopathology
Coronary Artery Disease - surgery
Coronary vessels
Cost analysis
Diameters
Double-Blind Method
Fractional Flow Reserve, Myocardial
Heart attacks
Heart diseases
Heart rate
Humans
Ischemia
Lesions
Medical imaging
Multicenter Studies as Topic - methods
Myocardial infarction
Patients
Percutaneous Coronary Intervention - methods
Physiology
Prospective Studies
Randomized Controlled Trials as Topic - methods
Stenosis
Stents
Strategy
Surgery, Computer-Assisted
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Summary: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.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2020.02.015