Clinical trial NCT03656848: The FAVOR III China Study
Official title: Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease (The FAVOR III China Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2018-09-04
Enrollment: 3847
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: The FAVOR III China is a prospective, multicenter, blinded, randomized, superiority clinical trial comparing the clinical outcome and cost-effectiveness of the two PCI strategies, QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only-guided (angiography-guided) strategy , in evaluation of patients with coronary artery disease (CAD). The study is adequately powered to detect if the primary outcome by the QFR-guided PCI strategy is superior to the standard angiography-guided PCI strategy. The hypothesis is that a QFR-guided PCI strategy results in superior clinical outcome, assessed by rate of Major Adverse Cardiac Events (MACE) defined as a composite of all-cause mortality, any myocardial infarction (MI) and any ischemia-driven revascularization at 1 year, compared to a standard angiography-guided PCI strategy. If QFR-guided strategy is shown to be superior to the angiography-guided strategy, the lower clinical costs and better clinical outcome by QFR may suggest it to be the preferred strategy for invasive functional evaluation of coronary artery stenosis.

The primary and major secondary endpoints will be analyzed in prespecified subgroups, including age, sex, diabetes, smoking status, acute coronary syndrome, body mass index, left ventricular ejection fraction, lesion location, length and reference vessel diameter, stenosis severity, multivessel disease, calcified lesion, bifurcation, tandem and bending/tortuous lesion, QFR gray zone (0.75-0.85), QFR based functional and residual functional SYNTAX score, residual QFR, center experience for invasive physiology, and learning experience with QFR.

For the purpose of protecting trial subjects and study personnel while maintaining trial data integrity during the coronavirus disease 2019 (COVID-19) pandemic, we particularly arranged an unscheduled telephone follow-up for all the participants, to evaluate the potential impact of the pandemic. Using a special designed follow-up questionnaire, all subjects were required to report the presence of COVID-19 infection and its related complications, any possible ischemia symptom, any hospitalization or outpatient visit, and interruption of cardiovascular medicine during this time (from Jan 20, 2019 to May 1, 2020). Clinical event committees (CEC) will update the working protocol to enable the re-adjudication of events from the onset of the pandemic to the end of the trial. All the events will be classified as related, possibly related, or not related to COVID-19 infection. To identify the interaction between COVID-19 pandemic and randomized revascularization strategy in the current study, several prespecified subsets will be added to the subgroups analysis, including COVID-19 positive vs. negative subjects, pre-pandemic vs. during pandemic vs. post-pandemic subjects, and the sites located at the high-risk region vs. low- to mediate-risk region.

Eligibility criteria: Inclusion Criteria:

General inclusion criteria:

* 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

Angiographic inclusion criteria:

* 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

Exclusion Criteria:

General exclusion criteria:

* 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

Angiographic exclusion criteria:

* 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

Primary outcomes:
measure: MACE
timeFrame: 1 year
Secondary outcomes:
measure: MACE excluding peri-procedural MI (Major secondary endpoint)
timeFrame: 1 year
measure: MACE
timeFrame: 1 month, 2 years, 3 years, 4 years and 5 years
measure: Death
timeFrame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
measure: MI
timeFrame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
measure: Target vessel revascularization (TVR)
timeFrame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
measure: Any coronary artery revascularization
timeFrame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
measure: Definite or probable stent thrombosis
timeFrame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years
measure: The PCI strategy changes based on the QFR and 3D-QCA
timeFrame: During the procedure
measure: Cost during 1-year follow-up
timeFrame: 1 month, 6 months, 1 year
measure: Quality-adjusted-life-years (QALYs) index
timeFrame: 1 month, 6 months, 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
name: Bo Xu, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
name: Shubin Qiao, MD
role: PRINCIPAL_INVESTIGATOR
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