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

Abstract

BACKGROUND:

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.

METHODS:

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.

CONCLUSIONS:

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.

• Authors: Lei Song, Shengxian Tu, Zhongwei Sun, Yang Wang, Daixin Ding, Changdong Guan, Lihua Xie, Javier Escaned, William F Fearon, Ajay J Kirtane, Patrick W Serruys, William Wijns, Stephan Windecker, Martin B Leon, Gregg W Stone, Shubin Qiao, Bo Xu, FAVOR III China Investigators
• Journal: American heart journal (Am Heart J) Vol. 223 Pg. 72-80 (05 2020) ISSN: 1097-6744 [Electronic] United States
• PMID: 32179258 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 Elsevier Inc. All rights reserved.

Topics

• Coronary Angiography
• Coronary Artery Disease (diagnostic imaging, physiopathology, surgery)
• Double-Blind Method
• Fractional Flow Reserve, Myocardial
• Humans
• Multicenter Studies as Topic (methods)
• Percutaneous Coronary Intervention (methods)
• Prospective Studies
• Randomized Controlled Trials as Topic (methods)
• Surgery, Computer-Assisted