FAVOR IV-QVAS
A Multicenter, Prospective, Randomized, Blind, Controlled Clinical Study to Compare the Efficacy of Quantitative Flow Ratio Guided and Coronary Angiography Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease
Sponsor study identifier
interventional
792
1 country
12
Study Start
August 4, 2019
Actual (reported)Primary Completion
September 30, 2024
Actual (reported)Study Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a multicenter, prospective, randomized, blinded, controlled clinical study in patients with planned primary valvular surgery and comorbid coronary artery lesions with diameter stenosis of ≥ 50%, to compare the effectiveness of an Quantitative Flow Ratio (QFR)-guided revascularization strategy and a coronary angiography (CAG)-guided revascularization strategy in preventing the incidence of composite outcome (MACE-5, including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, and new renal failure requiring dialysis) within 30 days after surgery. The study hypothesis is that the QFR-guided strategy can reduce the incidence of the MACE-5 within 30 days after surgery, as compared with the CAG-guided strategy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 5, 2019
Actual (reported)June 6, 2019
Actual (reported)August 4, 2019
Actual (reported)September 30, 2024
Actual (reported)August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The 30-day incidence of composite outcome (MACE-5) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, and new renal failure requiring dialysis
within 30 days after surgery
The time from randomization to first occurrence of any of composite outcome (MACE-6) within 1 year
within 1 year after surgery
The incidence of 1-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)
at 1 year after surgery
The time from randomization to first occurrence of any of composite outcome (MACE-6) within 3 year
within 3 years after surgery
The incidence of 3-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)
at 3 years after surgery
Health-related quality of life
within 30 days, 1 year and 3 years after surgery
The number of grafts per person
at Day 0
The total circulatory time during the surgery
at Day 0
The total cross-clamp time during the surgery
at Day 0
In this study, the QFR-guided strategy will be applied to in the QFR group in which calculation of the QFR values of all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and with suitability to CABG revascularization will be carried out. If QFR ≤ 0.80, then simultaneous CABG revascularization of target blood vessels will be carried out. If QFR \> 0.80, then no CABG revascularization of target blood vessels will be carried out.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second XiangYa Hospital of Central South University
Changsha, Hunan, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Zhu Y, Cheng Z, Zhao Y, Han L, Zhang W, Zhang C, Yang S, Ma L, Qiao C, Guo Z, Zhu D, Zhang X, Chen L, Wang Z, Ye X, Zhou M, Li H, Qiu J, Xu H, Sun Y, Zhu J, Xu Z, Qin G, Wijns W, Redfors B, Sandner S, Gaudino M, Tu S, Zhao Q. Angiography-derived fractional flow reserve versus coronary angiography to guide coronary artery bypass grafting in patients undergoing surgical valve procedures with concomitant coronary artery disease in China (FAVOR IV-QVAS): a multicentre, triple-blind, randomised trial. Lancet. 2026 Mar 21;407(10534):1161-1170. doi: 10.1016/S0140-6736(25)02418-3.
Zhu J, Zhu Y, Zhang W, Wang Z, Ye X, Zhou M, Li H, Qiu J, Xu H, Sun Y, Kang L, Tu S, Zhao Q. Preliminary outcomes of quantitative flow ratio-guided coronary bypass grafting in primary valve surgery: A propensity score weighted analysis. JTCVS Open. 2024 Jun 25;21:90-108. doi: 10.1016/j.xjon.2024.06.008. eCollection 2024 Oct.
Qiang Zhao, MD.
Ruijin Hospital
Shengxian Tu, PhD.
Med-X Research Institute, Shanghai Jiao Tong University
Yunpeng Zhu, MD.
Ruijin Hospital
Mario Gaudino, MD
Weill Medical College of Cornell University
792 participants (actual enrollment reported by the registry).
First Submitted
June 5, 2019
First Posted
June 6, 2019
Study Start
August 4, 2019
Actual (reported)In this study, CAG-guided strategy will be used for the control group, i.e., in accordance with current guideline recommendations, all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and suited for CABG revascularization will undergo CABG revascularization.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Primary Completion
September 30, 2024
Actual (reported)Study Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 17, 2025
Record last verified: 2025-09
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