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Disclosure Statement of Financial Interest

Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients with Stable Coronary Disease: Results from the FAME 2 trial.

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Disclosure Statement of Financial Interest

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  1. Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients with Stable Coronary Disease: Results from the FAME 2 trial William Fearon, Bernard De Bruyne, NicoPijls, David Shilane, Derek Boothroyd, PimTonino, EmmanueleBarbato, Peter Juni, and Mark Hlatky on behalf of the FAME 2 Trial Investigators

  2. Disclosure Statement of Financial Interest Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit St. Jude Medical, NIH HeartFlow Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company FAME 2 was sponsored by St. Jude Medical

  3. Fractional Flow Reserve Proximal Pressure (Pa) Distal Pressure (Pd) FFR = Pd / Pa during maximal flow Pa Pd / Pa = 60 / 100 FFR = 0.60 Pd

  4. FAME 2 Trial Stable patients with 1, 2, or 3 vessel CAD evaluated for PCI with DES n=1220 FFR in all target lesions Registry Randomized Trial At least 1 stenosis with FFR ≤ 0.80 (n=888) All FFR > 0.80 (n=322) Randomization 1:1 MT MT PCI + MT 50% randomly assigned to follow-up Primary Endpoint: Death, MI, Urgent Revascularization at 2 years

  5. FAME 2 Trial Results % De Bruyne, et al. New Engl J Med 2012;367:991-1001.

  6. Results Quality of Life at 1 Month

  7. Cumulative Costs over 12 Months $2,508 $5,485 % of study population 100% 56% 11%

  8. FFR-Guided PCI Cost-Effectiveness In-trial results $2,500 / 0.047 QALY = $53,000 / QALY Three Year Projection $2,500 / 0.079 QALY = $32,000 / QALY

  9. Cost-Effectiveness CE Benchmarks: Hemodialysis ≈ $50,000 / QALY WHO GDP std ≈ $150,000 / QALY >$150,000 / QALY $50K-150K / QALY <$50,000 / QALY

  10. Conclusion: • FFR-Guided PCI has higher initial cost than medical therapy. • The cost gap narrows >50% by one year. • Angina and quality of life are significantly improved by PCI. • FFR-Guided PCI appears to be economically attractive in cost-effectiveness analysis

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