Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.
Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (CAG). Lesions are often quantified by visual assessment of the angiogram, but physiological assessment of the functional significance by fractional flow reserve has been shown to improve clinical outcome, to reduce number of stents implanted, and has obtained the highest recommendation in European guidelines. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during medical induced maximum blood flow (hyperaemia). The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy but the need for interrogating the stenosis by a pressure wire, the small risks associated hereto, the cost of the wire, and the drug inducing hyperaemia has limited more widespread adoption. Quantitative Flow Ratio is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on computation of two angiographic projections. Two multi-center studies, the FAVOR II Europe-Japan and China studies evaluated the feasibility and diagnostic performance of in-procedure QFR, showing very good agreement between QFR and FFR. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy yields non-inferior 12-month clinical outcome compared to a standard pressure-wire guided strategy in evaluation of patients with stable angina pectoris and intermediate coronary stenosis. Primary hypothesis: A QFR based diagnostic strategy results in non-inferior clinical outcome, assessed by a composite endpoint of all cause death, non-fatal myocardial infarction (MI) and unplanned revascularization after one year, compared to a strategy of pressure wire-based FFR for assessment of physiological significance of intermediate coronary artery stenosis. Methods: Investigator initiated, 1:1 randomized, prospective, clinical outcome, non-inferiority, multi-center trial performed at up to 40 international sites with inclusion of 2000 patients. Patients with stable angina pectoris or need for evaluation of non-culprit lesions after acute MI are enrolled. At least two angiographic projections are acquired during resting conditions. If the angiographic criteria are met, the patient is randomized to either a QFR- or an FFR-based diagnostic strategy. Revascularization is performed according to best standard by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Patient follow-up is continued until 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
2,001
Novel computer based calculation of lesion severity. Pressure wire-free and adenosine-free
Standard FFR based diagnostic method. Pressure drop across the stenosis is measured with a pressure wire during medical induced hyperaemic conditions
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus N, Denmark
Gentofte Hospital
Hellerup, Denmark
Institut Arnault Tzanck
Saint-Laurent-du-Var, Nice, France
GCS ES Axium - Parc Rambot
Aix-en-Provence, France
CHU de Lille, Lille University Hospital
Patient oriented composite endpoint (PoCE)
A composite endpoint of 1) all-cause mortality, 2) any myocardial infarction, and 3) any unplanned revascularization
Time frame: 12 months
Target vessel failure
A composite of cardiac death, target vessel myocardial infarction and ischemic driven target vessel revascularization.
Time frame: 1 month
Target vessel failure
A composite of cardiac death, target vessel myocardial infarction and ischemic driven target vessel revascularization.
Time frame: 12 months
Target vessel failure
A composite of cardiac death, target vessel myocardial infarction and ischemic driven target vessel revascularization.
Time frame: 24 months
All-cause mortality
Total death includes cardiac death and other fatal categories such as cerebrovascular death, death from other cardiovascular disease (i.e. pulmonary embolism, dissection aortic aneurism will be included in this category), death from malignant disease, death from suicide, violence or accident, or death from other reasons.
Time frame: 1 month
All-cause mortality
Total death includes cardiac death and other fatal categories such as cerebrovascular death, death from other cardiovascular disease (i.e. pulmonary embolism, dissection aortic aneurism will be included in this category), death from malignant disease, death from suicide, violence or accident, or death from other reasons.
Time frame: 12 months
All-cause mortality
Total death includes cardiac death and other fatal categories such as cerebrovascular death, death from other cardiovascular disease (i.e. pulmonary embolism, dissection aortic aneurism will be included in this category), death from malignant disease, death from suicide, violence or accident, or death from other reasons.
Time frame: 24 months
Cardiac death
Encompasses death due to coronary heart disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related the cardiac procedure within 28 days from the procedure. If death is not clearly attributable to other non-cardiac causes it is adjudicated as cardiac death
Time frame: 1 month
Cardiac death
Encompasses death due to coronary heart disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related the cardiac procedure within 28 days from the procedure. If death is not clearly attributable to other non-cardiac causes it is adjudicated as cardiac death
Time frame: 12 months
Cardiac death
Encompasses death due to coronary heart disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related the cardiac procedure within 28 days from the procedure. If death is not clearly attributable to other non-cardiac causes it is adjudicated as cardiac death
Time frame: 24 months
Myocardial infarction
Procedure and non-procedure related myocardial infarction. Protocol defined.
Time frame: 1 month
Myocardial infarction
Procedure and non-procedure related myocardial infarction. Protocol defined.
Time frame: 12 months
Myocardial infarction
Procedure and non-procedure related myocardial infarction. Protocol defined.
Time frame: 24 months
Target vessel myocardial infarction
As "any myocardial infarction", but with culprit lesion in index vessel.
Time frame: 1 month
Target vessel myocardial infarction
As "any myocardial infarction", but with culprit lesion in index vessel.
Time frame: 12 months
Target vessel myocardial infarction
As "any myocardial infarction", but with culprit lesion in index vessel.
Time frame: 24 months
Any unplanned revascularization
Coronary artery bypass grafting (CABG) or PCI of any lesion. Planned Revascularization: Revascularization is considered planned when it is decided at the time of the index procedure, based on the results of angiography and functional testing. Planned revascularization could be performed at the time of the index procedure or within 60 days. Such revascularization is considered as "primary" revascularization and is not considered as an endpoint. The "planned" status of the revascularization is adjudicated. Unplanned Revascularization: Revascularization is considered "unplanned" when not performed as part of standard care during the index procedure or if it is not planned as a staged procedure to occur within 60 days.
Time frame: 1 month
Any unplanned revascularization
Coronary artery bypass grafting (CABG) or PCI of any lesion. Planned Revascularization: Revascularization is considered planned when it is decided at the time of the index procedure, based on the results of angiography and functional testing. Planned revascularization could be performed at the time of the index procedure or within 60 days. Such revascularization is considered as "primary" revascularization and is not considered as an endpoint. The "planned" status of the revascularization is adjudicated. Unplanned Revascularization: Revascularization is considered "unplanned" when not performed as part of standard care during the index procedure or if it is not planned as a staged procedure to occur within 60 days.
Time frame: 12 months
Any unplanned revascularization
Coronary artery bypass grafting (CABG) or PCI of any lesion. Planned Revascularization: Revascularization is considered planned when it is decided at the time of the index procedure, based on the results of angiography and functional testing. Planned revascularization could be performed at the time of the index procedure or within 60 days. Such revascularization is considered as "primary" revascularization and is not considered as an endpoint. The "planned" status of the revascularization is adjudicated. Unplanned Revascularization: Revascularization is considered "unplanned" when not performed as part of standard care during the index procedure or if it is not planned as a staged procedure to occur within 60 days.
Time frame: 24 months
Any ischemia driven de novo revascularization
Coronary artery bypass grafting or PCI of a vessel that was not evaluated nor treated during the index procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI
Time frame: 1 month
Any ischemia driven de novo revascularization
Coronary artery bypass grafting or PCI of a vessel that was not evaluated nor treated during the index procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI
Time frame: 12 months
Any ischemia driven de novo revascularization
Coronary artery bypass grafting or PCI of a vessel that was not evaluated nor treated during the index procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI
Time frame: 24 months
Ischemia driven target vessel revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI
Time frame: 1 month
Ischemia driven target vessel revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI
Time frame: 12 months
Ischemia driven target vessel revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI
Time frame: 24 months
Ischemia driven treated target lesion revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia that was treated during index or planned staged procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI
Time frame: 1 month
Ischemia driven treated target lesion revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia that was treated during index or planned staged procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI
Time frame: 12 months
Ischemia driven treated target lesion revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia that was treated during index or planned staged procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI
Time frame: 24 months
Ischemia driven, measured segment revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR but not treated. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI.
Time frame: 1 month
Ischemia driven, measured segment revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR (both treated and not treated). In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI.
Time frame: 12 months
Ischemia driven, measured segment revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR but not treated. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI.
Time frame: 24 months
Ischemia driven measured segment de novo revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR but not treated. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI.
Time frame: 1 month
Ischemia driven measured segment de novo revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR but not treated. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI.
Time frame: 12 months
Ischemia driven measured segment de novo revascularization
Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR but not treated. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI.
Time frame: 24 months
Feasibility of QFR
Percentage of successful QFR in patients allocated to a QFR based diagnostic strategy
Time frame: 1 hour
Feasibility of FFR
Percentage of successfully performed FFR measurements in vessels with attempted FFR (vessel level) Percentages of patients with successful FFR measurements (all attempted)
Time frame: 1 hour
Number of lesion interrogated
Total number of lesions diagnosed with either QFR or FFR during the procedure
Time frame: 1 hour
Procedure time
Time from introduction of the sheet until the sheet for coronary access is removed from the patient
Time frame: 1 hour
Contrast volume
Total volume of contrast used in the procedure
Time frame: 1 hour
Fluoroscopy time
Total fluoroscopy time for the procedure
Time frame: 1 hour
Number of stents implanted
Total number of stents implanted during the procedure. Stents implanted in a staged procedure are included
Time frame: 1 hour
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lille, France
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Massy, France
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Pessac, France
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Quincy, France
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