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

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 Jelmer.westra@clin.au.dk

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 Jelmer.westra@clin.au.dk

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 Jelmer.westra@clin.au.dk

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 Jelmer.westra@clin.au.dk

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 Jelmer.westra@clin.au.dk

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 Jelmer.westra@clin.au.dk

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 Jelmer.westra@clin.au.dk

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 Jelmer.westra@clin.au.dk

Results – Time to QFR and FFR FAVOR II E-J Results – Time to QFR and FFR 4.8 m (IQR: 3.5-6.0) 7.0 m (IQR: 5.0-10.0) P=<0.001 SKEJBY PCI Research Aarhus University Hospital, Skejby ● Denmark Aarhus University Hospital FAVOR II Europe-Japan Jelmer.westra@clin.au.dk

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 Jelmer.westra@clin.au.dk