1. FAVOR II Europe-Japan FAVOR II E-J
Diagnostic Accuracy of On-line Quantitative Flow Ratio Functional Assessment by Virtual Online Reconstruction:
FAVOR II Europe-Japan
On behalf of the FAVOR II study group
Jelmer Westra
PCI Research
Aarhus University Hospital, Skejby ● Denmark

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Accuracy (%)
Affiliation/Financial Relationship
Company
Grant/Research Support
Consulting Fees/Honoraria
Medis medical imaging bv.
Funding
The study was funded by Aarhus University Hospital, Skejby and participating institutions.
Medis Medical Imaging bv. provided no funding for the study except limited travel arrangements for initiation and monitoring visits.
The QFR solution was made available for free during the study period.
SKEJBY
PCI Research
Aarhus University Hospital, Skejby ● Denmark
Aarhus University Hospital
FAVOR II Europe-Japan

3. Background FAVOR II E-J
In patients with angina pectoris, evaluation of coronary stenosis by costly invasive pressure wire measurements is the present gold standard.
In clinical practice, decision to treat a stenosis or not, is often based on angiographic evaluation.
Quantitative flow ratio (QFR) is a computational method for emulating pressure wire measurements that has showed good agreement with the current gold standard Fractional flow reserve (FFR)*
Feasibility and precision of QFR are unknown when performed during coronary angiography and in a multicenter setting.
*Tu et al.; JACC Cardiovasc Interv 2016
Westra et al.; WIFI II, TCT 2016
SKEJBY
PCI Research
Aarhus University Hospital, Skejby ● Denmark
Aarhus University Hospital
FAVOR II Europe-Japan

4. QFR analysis FAVOR II E-J QFR is an estimate of FFR based on:
Accuracy (%) mm
QFR is an estimate of FFR based on:
3-D reconstructions
theoretical fluid dynamics
QFR by Medis Suite, Medis medical imaging. CE-marked. Not approved for clinical use in the US.
SKEJBY
PCI Research
Aarhus University Hospital, Skejby ● Denmark
Aarhus University Hospital
FAVOR II Europe-Japan

5. FAVOR II E-J
Purpose
To evaluate the feasibility and precision of in-procedure QFR compared to standard quantitative angiographic assessment with FFR as reference standard
SKEJBY
PCI Research
Aarhus University Hospital, Skejby ● Denmark
Aarhus University Hospital
FAVOR II Europe-Japan

6. Primary endpoint FAVOR II E-J Sensitivity and specificity of :
QFR compared to two-dimensional quantitative coronary angiography (2D-QCA)
- in assessing functional stenosis relevance
with FFR as reference standard
SKEJBY
PCI Research
Aarhus University Hospital, Skejby ● Denmark
Aarhus University Hospital
FAVOR II Europe-Japan

7. Design FAVOR II E-J Investigator initiated study Observational study
Both acquisition of FFR and computation of QFR in all patients
Site specific protocol for effective blinding
Strict protocol for QFR analysis
More than one study vessel pr. patient allowed
Planned enrolment of 310 patients to ensure at least 274 study vessel in the final analysis
11 hospitals in Europe and Japan
Enrolment period: March 2017 to October 2017
SKEJBY
PCI Research
Aarhus University Hospital, Skejby ● Denmark
Aarhus University Hospital
FAVOR II Europe-Japan

8. Primary endpoint FAVOR II E-J QFR 2D-QCA Vessels (n=317) Sensitivity
Specificity
88% (80-93)
88% (83-92)
46% (36-55)
77% (70-82)
QFR
2D-QCA
Comparisons by McNemar’s test
SKEJBY
PCI Research
Aarhus University Hospital, Skejby ● Denmark
Aarhus University Hospital
FAVOR II Europe-Japan

9. Primary endpoint FAVOR II E-J FAVOR II E-J met the primary endpoint;
Vessels (n=317)
p<0.001
p<0.001
FAVOR II E-J met the primary endpoint;
QFR was superior to standard quantitative angiographic diagnosis
Sensitivity
Specificity
88% (80-93)
88% (83-92)
46% (36-55)
77% (70-82)
QFR
2D-QCA
Comparisons by McNemar’s test
SKEJBY
PCI Research
Aarhus University Hospital, Skejby ● Denmark
Aarhus University Hospital
FAVOR II Europe-Japan

10. Results – Time to QFR and FFR
FAVOR II E-J
Results – Time to QFR and FFR
4.8 m (IQR: )
7.0 m (IQR: )
P=<0.001
SKEJBY
PCI Research
Aarhus University Hospital, Skejby ● Denmark
Aarhus University Hospital
FAVOR II Europe-Japan

11. Conclusion FAVOR II E-J
QFR was superior to standard quantitative angiographic assesment for detection of stenosis requiring revascularization using FFR as reference standard
QFR performed during coronary angiography was feasible and was computed within the time of standard FFR measurements
Randomized trials are required to determine if a QFR based diagnostic strategy provides clinical outcome similar to pressure wire based strategies
SKEJBY
PCI Research
Aarhus University Hospital, Skejby ● Denmark
Aarhus University Hospital
FAVOR II Europe-Japan