PCIs on Intermediate Lesions NCDR Cath-PCI Registry

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1 Practical Application Of Coronary Physiology in The Cath Lab Talal T Attar, MD, MBA, FACC PCIs on Intermediate Lesions NCDR Cath-PCI Registry Fraction of stenoses 50-70% treated with PCI without further physiologic evaluation NCDR data. Fraction of total # of PCIs over respective rolling 4 quarters For distribution in the USA only Medtronic, Inc. All rights reserved. UC EN 06/15 1

2 Fractional Flow Reserve (FFR) 3 Fractional Flow Reserve (FFR) FFR is the ratio of the maximum achievable blood flow distal to a stenotic lesion divided by maximum blood flow in the same artery with no stenosis Proximal Pressure (P a) Distal Pressure (P d) FFR = mean P d / mean P a during maximal hyperemia P a = Aortic pressure, measured through coronary guide P d = Pressure distal to lesion, measured with pressure sensor FFR = 1.00 Normal blood flow; no reduction in blood flow distal to target lesion(s) FFR = 0.69 During maximum hyperemia, 69% of normal blood flow is able to reach myocardium distal to target lesion(s). 2

3 Unique Aspects of FFR Normal value of FFR = 1.0 in all patients Independent of the microvasculature Specific for the epicardial vessels Not affected by hemodynamic changes Accounts for collateral flow Reproducible Fearon WF, Fractional Flow Reserve Guided Percutaneous Coronary Intervention, in Coronary Stenting: A Companion to Topol's Textbook of Interventional Cardiology (Price MJ, Ed) FAME 2: Study Design FFR-Guided PCI vs. Medical Therapy in Stable CAD Stable CAD patients with 1, 2 or 3 vessel CAD evaluated for PCI with DES N = 1220 Randomized Trial FFR in all target lesions Registry At least 1 stenosis with FFR 0.80 (n=888) When all FFR >0.80 (n=332) Randomization 1:1 PCI + MT 73% MT 27% MT 50% randomly assigned to FU Primary Endpoint: Death, MI, or urgent revascularization at 2 Years Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years Clinicaltrials.gov identifier: NCT De Bruyne et al. N Engl J Med. 2012;367: For distribution in the USA only Medtronic, Inc. All rights reserved. UC EN 06/15 3

4 FAME 2: Primary Endpoint at 2 Years MACE (Death, MI, Revascularization) Cumulative Incidence (%) PCI+MT vs MT: HR 0.39 (95% CI ) P<0.001 PCI+MT vs Registry: HR 0.90 (95% CI ) P=0.72 MT vs Registry: HR 2.34 (95% CI ) P= % 9.0% 8.1% No. at risk MT PCI+MT Registry Months After Randomization MT alone PCI+MT Registry De Bruyne et al. N Engl J Med. 2014;371: For distribution in the USA only Medtronic, Inc. All rights reserved. UC EN 06/15 FAME 2: Death or MI to 2 Years Landmark Analysis at 7 Days Cumulative Incidence (%) Cumulative Incidence (%) PCI+MT vs MT: 0-7 days: HR 9.01 (95% CI ) P for interaction days-2 years: HR 0.56 (95% CI ) Days After Randomisation Months After Randomisation P= % 4.6% MT alone PCI+MT De Bruyne et al. N Engl J Med. 2014;371: For distribution in the USA only Medtronic, Inc. All rights reserved. UC EN 06/15 4

5 Functional vs. Angiographic Lesion Severity FAME Trial Frequency (%) of FFR 0.80 Diameter Stenosis by Angiography 65% of lesions with angiographic severity of 50-70% were functionally non-significant by FFR Tonino PA et al. JACC. 2010;55: For distribution in the USA only Medtronic, Inc. All rights reserved. UC EN 06/15 Incorporating Physiology Into Risk Assessment Reduces Complexity SYNTAX Score FSS Score* Low 163 (32%) 167 (34%) 167 (34%) Medium High 101 (20%) 106 (21%) 290 (59%) Using FFR, 32% of patients moved from a higher-risk group to a lower-risk group *FSS=Functional Syntax Score calculated by separately adding the individual SYNTAX scores of lesions with a FFR 0.80 and ignoring lesions with FFR >0.80 Nam, C-W, et al. J Am Coll Cardiol. 2011;58:

6 ACC Guidelines FFR is reasonable to assess angiographic intermediate coronary lesions (50% to 70% diameter stenosis) and can be useful for guiding revascularization decisions in patients with SIHD Class 2 A 11 Appropriate Use Criteria FFR is A Key Element In Guidance for Indeterminate Stenosis and No Non-invasive Testing Patients without Prior Bypass Surgery Indication Appropriate Use Score (1 9) CCS Angina Class Asymptomatic I or II II III or IV 21. One- or 2-vessel CAD with borderline stenosis 50% to 60% Not rated I (2) I (3) No noninvasive testing performed No further invasive evaluation performed (i.e., FFR, IVUS) 22. One- or 2-vessel CAD with borderline stenosis 50% to 60% I (3) U (6) A (7) No noninvasive testing performed or equivocal test results present FFR less than or equal to 0.80* and/or IVUS with significant reduction in cross-sectional area 23. One- or 2-vessel CAD with borderline stenosis 50% to 60% No noninvasive testing performed or equivocal test results present FFR or IVUS findings do not meet criteria for significant stenosis I (1) I (2) I (2) Patel MR et al. J Am Coll Cardiol. 2012;59(9):

7 Can We Make Things Even Simpler?

8 15 How About (IFR) Instantaneous Wave-Free Ratio 16 8

9 IFR concept Coronary pressure is simple to measure P = Q X R P Q X R

10 19 20 Johnson, N et al, JACC, 2013, 61, (13)

11 21 Johnson, N et al, JACC, 2013, 61, (13) Johnson, N et al, JACC, 2013, 61, (13)

12 An IFR cut point of 0.89 matches an FFR cut point of 0.8 FFR and IFR have a different scale Celsius & Fahrenheit both measure temperature, but have a different scale FFR Treat Defer 0.8 IFR Treat Defer Johnson, N et al, JACC, 2013, 61, (13)

13 Comparison of IFR to FFR 25 Comparison of IFR to FFR 26 13

14 27 The hybrid IFR/FFR Approach 94.0% match to FFR1 65.1% of patients may be free from hyperemic agents 28 14

15 29 While We are At It Is there Something Called CFR? 30 15

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17 33 One More Practical Question. Adenosine. IC or IV? 34 17

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20 Take Home Lessons 39 Take Home Points FFR becoming the gold standard for symptomatic CAD management when there are no objective evidence of ischemia IFR is a reasonable alternative with 94% correlation with FFR and 65% Adenosine free rate CFR is a helpful research tool. Might have a use in the evaluation of Micro Vascular ischemia Equipment's do not practice medicine. Doctors do!! Tests Do Not Replace Clinical Judgment 40 20

21 FFR as a Continuous Marker of Risk Conceptual Relationship Between FFR and Outcomes Highest Medically treated Subsequent Event Rate (%) Medium Low PCI decreases event rate most at low FFR Revascularized Optimal threshold PCI probably increases events at high FFR Low Threshold High 1.0 Fractional Flow Reserve (FFR) Lesions with lower FFR values receive larger absolute benefits from revascularization. Johnson NP, et al. J Am Coll Cardiol. 2014;64(16): For distribution in the USA only Medtronic, Inc. All rights reserved. UC EN 06/15 21