The FAVOR III China Study

NCT03656848 | Unknown DMC

• 1 other identifier: FAVOR III China - 2508
• Study Type: interventional
• Target: 3,847
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of the FAVOR III China trial is to investigate if a strategy of quantitative flow ratio (QFR)-guided percutaneous coronary intervention (PCI) yields superior clinical outcome and cost-effectiveness compared to a strategy of standard coronary angiography-guided PCI in evaluation of patients with coronary artery disease.

Conditions

Coronary Artery Disease; Myocardial Ischaemia; Coronary Circulation; Coronary Stenosis; Percutaneous Coronary Intervention

Keywords

Quantitative Coronary Angiography; Quantitative Flow Ratio; Coronary Artery Disease; Myocardial Ischaemia; Percutaneous Coronary Intervention; Coronary Circulation

Outcome Measures

Primary Outcomes (1)

• MACE

  A composite of all-cause mortality, any myocardial infarction and any ischemia-driven revascularization

  1 year

Secondary Outcomes (10)

• MACE excluding peri-procedural MI (Major secondary endpoint)

  1 year

• MACE

  1 month, 2 years, 3 years, 4 years and 5 years

• Death

  1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years

• MI

  1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years

• Target vessel revascularization (TVR)

  1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years

Study Arms (2)

QFR-guided PCI group

EXPERIMENTAL

If the patient is assigned to QFR-guided PCI, QFR is first measured in all coronary arteries with DS% ≥ 50% and ≤ 90%. Then PCI treatment is performed in lesions with QFR ≤ 0.80, and optimal medicine treatment is prescribed to those with QFR \> 0.80. It is strongly recommended to select the device size based on the 3D-QCA measurements in this group.

Diagnostic Test: QFR; Diagnostic Test: Angiography

Angiography-guided PCI group

ACTIVE COMPARATOR

If the patient is assigned to angiography-guided PCI, then the investigator performs PCI according to the stenosis severity based on visual assessment of the angiogram. No other functional tests such as FFR/iFR can be used for further assessment of the lesion before PCI.

Diagnostic Test: Angiography

Interventions

QFR DIAGNOSTIC_TEST

QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two angiographic projections.

Also known as: Quantitative Flow Ratio

QFR-guided PCI group

Angiography DIAGNOSTIC_TEST

Coronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries

Also known as: Coronary angiography

Angiography-guided PCI group; QFR-guided PCI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Stable or unstable angina pectoris, or post-acute myocardial infarction (≥ 72 hrs)
• Signed written informed consent
• Eligible for PCI by the operators
• At least one lesion is present of DS% ≥50% and ≤90% in one major native epicardial coronary artery and supplying viable myocardium
• Reference lumen diameter ≥ 2.5mm by visual assessment

You may not qualify if:

• Cardiogenic shock or severe heart failure (NYHA ≥III)
• Severely impaired renal function: creatinine \> 150μmol/L or Cockcroft-Gault calculated GFR \< 45 ml/kg/1.73 m2
• Allergy to iodine-containing contrast agents
• Pregnancy or intention to become pregnant during the course of the trial
• Life expectancy less than one year
• With only one coronary artery lesion（DS%\>90%）with TIMI flow \< 3
• Target stenoses are culprit lesions related with acute myocardial infarction
• Target stenoses in the vessel involving myocardial bridge
• Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast filling
• Severe overlap in the stenosed segment or severe tortuosity of any target vessel deemed unable for QFR measurement

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (16)

• Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.

  PMID: 27712739 BACKGROUND

• Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.

  PMID: 29980523 BACKGROUND

• Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.

  PMID: 29101020 BACKGROUND

• Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

  PMID: 19144937 BACKGROUND

• De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.

  PMID: 22924638 BACKGROUND

• Song L, Tu S, Sun Z, Wang Y, Ding D, Guan C, Xie L, Escaned J, Fearon WF, Kirtane AJ, Serruys PW, Wijns W, Windecker S, Leon MB, Stone GW, Qiao S, Xu B; FAVOR III China Investigators. Quantitative flow ratio-guided strategy versus angiography-guided strategy for percutaneous coronary intervention: Rationale and design of the FAVOR III China trial. Am Heart J. 2020 May;223:72-80. doi: 10.1016/j.ahj.2020.02.015. Epub 2020 Feb 24.

  PMID: 32179258 BACKGROUND

• Xu B, Tu S, Song L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Fu X, Liu J, Zhao Y, Escaned J, Wang Y, Fearon WF, Dou K, Kirtane AJ, Wu Y, Serruys PW, Yang W, Wijns W, Guan C, Leon MB, Qiao S, Stone GW; FAVOR III China study group. Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial. Lancet. 2021 Dec 11;398(10317):2149-2159. doi: 10.1016/S0140-6736(21)02248-0. Epub 2021 Nov 4.

  PMID: 34742368 RESULT

• Jin Z, Xu B, Yang X, Jia R, Meng S, Hu H, Deng Y, Cao X, Ruan Y, Han J, Liu J, Qu X, Zhou Y, Wang J, Fu G, Yu B, Wang Y, Guan C, Song L, Tu S, Qiao S, Stone GW; FAVOR III China Study Group. Coronary Intervention Guided by Quantitative Flow Ratio vs Angiography in Patients With or Without Diabetes. J Am Coll Cardiol. 2022 Sep 27;80(13):1254-1264. doi: 10.1016/j.jacc.2022.06.044.

  PMID: 36137676 RESULT

• Song L, Xu B, Tu S, Guan C, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Yang J, Liu X, Guo L, Shen C, Zhang Y, Zhang Q, Pan H, Zhang R, Liu J, Zhao Y, Wang Y, Dou K, Kirtane AJ, Wu Y, Wijns W, Yang W, Leon MB, Qiao S, Stone GW; FAVOR III China Study Group. 2-Year Outcomes of Angiographic Quantitative Flow Ratio-Guided Coronary Interventions. J Am Coll Cardiol. 2022 Nov 29;80(22):2089-2101. doi: 10.1016/j.jacc.2022.09.007. Epub 2022 Sep 19.

  PMID: 36424680 RESULT

• Zhang R, Wang HY, Song L, Guan C, Yin D, Zhu C, Feng L, Jin Z, Yu B, Fu G, Zhou Y, Wang J, Chen Y, Pu J, Chen L, Qu X, Zhao Y, Wang Y, Liu W, Qiao S, Tu S, Wijns W, Dou K; FAVOR III China Study Group. Rationales Behind Physiology-Guided Revascularization: Diagnostic Impact of Quantitative Flow Ratio in the FAVOR III China Trial. JACC Cardiovasc Interv. 2025 Nov 20:S1936-8798(25)02702-5. doi: 10.1016/j.jcin.2025.10.042. Online ahead of print.

  PMID: 41263729 DERIVED

• Ding S, Zhou Z, Zou Z, Cheng F, Sheng X, Liu X, Guo L, Shen C, Zhang Y, Pan H, Xu Y, Chu M, Wang Y, Guan C, Tu S, Kirtane AJ, Qiao S, Song L, Stone GW, Pu J; FAVOR III China Study Group. Two-year outcomes of quantitative flow ratio-based physiology-guided percutaneous coronary intervention in patients with low-risk acute coronary syndrome: a prespecified secondary analysis of FAVOR III China. EClinicalMedicine. 2025 Aug 30;88:103461. doi: 10.1016/j.eclinm.2025.103461. eCollection 2025 Oct.

  PMID: 40926902 DERIVED

• Geng Y, Guan C, Jiang Y, Yang W, Yu B, Fu G, Pu J, Qu X, Zhang Q, Zhao Y, Yu L, Huang Y, Tu S, Qiao S, Song L. Prognostic impact of guideline-directed medical therapy after functionally complete revascularisation in patients with obstructive coronary artery diseases. Heart. 2025 Aug 7:heartjnl-2025-325670. doi: 10.1136/heartjnl-2025-325670. Online ahead of print.

  PMID: 40780826 DERIVED

• Dai J, Guan C, Xu X, Hou J, Jia H, Yu H, Jin Z, Fu G, Wu X, Wang L, Huang R, Shen Z, Zhao Y, Jin Y, Song L, Tu S, Qiao S, Yu B, Xu B, Stone GW; FAVOR III China study group. Angiographic Quantitative Flow Ratio-Guided Treatment of Patients With Physiologically Intermediate Coronary Lesions. J Am Heart Assoc. 2025 Apr;14(7):e035756. doi: 10.1161/JAHA.124.035756. Epub 2025 Mar 21.

  PMID: 40118790 DERIVED

• Zhao Y, Guan C, Wang Y, Jin Z, Yu B, Fu G, Chen Y, Guo L, Qu X, Zhang Y, Dou K, Wu Y, Yang W, Tu S, Escaned J, Fearon WF, Qiao S, Cohen DJ, Krumholz HM, Xu B, Song L; FAVOR III China Study Group. Cost-effectiveness of angiographic quantitative flow ratio-guided coronary intervention: A multicenter, randomized, sham-controlled trial. Chin Med J (Engl). 2025 May 20;138(10):1186-1193. doi: 10.1097/CM9.0000000000003484. Epub 2025 Mar 3.

  PMID: 40025631 DERIVED

• Chen Y, Gao L, Vogel B, Tian F, Jin Q, Guo J, Sun Z, Yang W, Jin Z, Yu B, Fu G, Pu J, Qu X, Zhang Q, Zhao Y, Yu L, Guan C, Tu S, Qiao S, Xu B, Mehran R, Song L; FAVOR III China Study Group. Sex Differences in Clinical Outcomes Associated With Quantitative Flow Ratio-Guided Percutaneous Coronary Intervention. JACC Asia. 2023 Nov 28;4(3):201-212. doi: 10.1016/j.jacasi.2023.09.012. eCollection 2024 Mar.

  PMID: 38463683 DERIVED

• Tu S, Xu B, Chen L, Hong H, Wang Z, Li C, Chu M, Song L, Guan C, Yu B, Jin Z, Fu G, Liu X, Yang J, Chen Y, Ge J, Qiao S, Wijns W; FAVOR III China Study Group. Short-Term Risk Stratification of Non-Flow-Limiting Coronary Stenosis by Angiographically Derived Radial Wall Strain. J Am Coll Cardiol. 2023 Feb 28;81(8):756-767. doi: 10.1016/j.jacc.2022.11.056.

  PMID: 36813375 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Interventions

Angiography; Coronary Angiography

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Cardiac Imaging Techniques; Heart Function Tests

Study Officials

• Bo Xu, MBBS

  Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Shubin Qiao, MD

  Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a blinded clinical trial. Subjects and clinical assessor will be blinded to the assignment results. All the study site personnel will receive training for the blinding measures before the trial initiating. In addition to standard procedural sedation, music-playing headphones will be worn by the patient during the whole procedure, and patients in both groups will be preset a 10 minutes delay for QFR calculation before the PCI procedure, a lesion/device evaluation form is required to fill in during the period in both groups, to reduce the possibility of unblinding. All the study site personnel will be trained not to disclose the treatment assignment to the subject in any unplanned time. Subject blinding should be maintained until the one-year follow-up visit for all registered subjects is completed.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Catheterization Laboratories

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 4, 2018
• Study Start: December 25, 2018
• Primary Completion: February 19, 2021
• Study Completion: February 19, 2025
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)