Lei Song1, Shengxian Tu2, Zhongwei Sun3, Yang Wang4, Daixin Ding2, Changdong Guan3, Lihua Xie3, Javier Escaned5, William F Fearon6, Ajay J Kirtane7, Patrick W Serruys8, William Wijns9, Stephan Windecker10, Martin B Leon7, Gregg W Stone11, Shubin Qiao12, Bo Xu13. 1. Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. 2. Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China. 3. Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. 4. Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China. 5. Hospital Clinico San Carlos, Madrid, Spain. 6. Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA. 7. New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY. 8. National Heart and Lung Institute, Imperial College London, London, United Kingdom. 9. The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, Ireland. 10. Bern University Hospital, Bern, Switzerland. 11. Cardiovascular Research Foundation, New York, NY; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY. 12. Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: qsbfw@sina.com. 13. Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: bxu@citmd.com.
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.
RCT Entities:
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 diseasepatients.
Authors: Mina Ghobrial; Hazel Arfah Haley; Rebecca Gosling; Vignesh Rammohan; Patricia V Lawford; D Rod Hose; Julian P Gunn; Paul D Morris Journal: Heart Date: 2021-01-08 Impact factor: 5.994