Appendix FFR Clinical Benefit of FFR 1 Fractional Flow Reserve (FFR) Definition of FFR: “Maximum achievable blood flow in stenotic coronary artery divided by maximum blood flow in the same artery without stenosis” 2 FFR Measurement Correlates to the Likelihood of Ischemia Fractional Flow Reserve (FFR) is a lesion-specific, physiological index determining the hemodynamic severity of intracoronary lesions. FFR accurately identifies lesions responsible for ischemia that in many cases angiography or IVUS would not have undetected or correctly assessed. FFR measurement correlates to the likelihood of ischemia with a validated cut-off value of 0.75. 3 The FAME Study The objective of the FAME (FFR versus Angiography for Multivessel Evaluation) study was to determine if routine measurement of fractional flow reserve, when combined with angiography, improves outcomes in patients undergoing percutaneous coronary intervention (PCI). 4 FAME Study Design Chart Patient with lesions ≥ 50% in at least 2 of the 3 major epicardial vessels Indicate all lesions ≥ 50% amenable for stenting Randomization FFR-guided PCI Angiography-guided PCI Measure FFR in all arteries with ≥ 1 stenosis Stent only those stenoses with FFR ≤ 0.80 Stent all indicated stenoses 1, 2 and 5-year follow-up 5 Exclusion criteria: LM disease, Previous CABG MI < 5 days, unless cardiogenic shock Pregnancy, Life expectancy < 2 years FAME Study Angiographic stenosis severity vs. FFR values 6 Tonino PA, Fearon WF, De Bruyne B, et al. Angiographic versus functional severity of coronary artery stenoses in the FAME Study: Fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol. 2010;55;25:2816. The FAME Study Results¹’² Compared to angiography-only procedures, FAME one-year results show that FFR: Reduces MACE at one year by 28%. Reduces mortality and myocardial infarction at one year by 34%. Is cost saving and does not prolong procedure time. Decreases amount of contrast agent used. Results in similar, if not better, functional status. FAME two-year results show that FFR: Reduces mortality and myocardial infarction (combined) by 34%. Reduces myocardial infarction alone by 37%. Is cost saving and improves procedure outcomes. Saves on average $2,066 over one year. 1. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-24 2. TCT (Transcatheter Cardivascular Therapeutics) 2009, Late Breaking Clinical Trials 7 FAME: Economics Sub-Analysis and Comparisons Across Seven Countries Cost-Effective vs. Cost-Saving Cost-Effective: A treatment option that results in benefits sufficiently large compared to the costs, even if it does not save money. What is considered cost-effective (i.e. good value for the money) can differ from country to country. Cost-Saving A treatment option that decreases total costs and improves outcomes. 9 2 (example Germany) Cost Effectiveness Cost Effectiveness¹ (example Germany) Increm. Cost (€) 2000 -0.075 -0.050 -0.025 FFR is clearly both costsaving and cost-effective 1500 1000 ICER of 50,000 €/QALY 500 0 -0.000 -500 0.025 0.050 0.075 Increm. QALY -1000 -1500 -2000 1. Siebert U. Cost-Effectiveness and Public Health/Budget-Impact of FFR-Guided PCI in Multivessel Patients in Europe—Analysis of the FAME Study Data. EuroPCR, 2011. 10 Results Cost Effectiveness Planes: FFR vs.vs. Angio¹ Results Cost-Effectiveness Planes: FFR Angio -0.075 2000 1500 1000 500 ICER of 50,000 €/QALY 0 -0.050 -0.025 -0.000 0.025 0.050 0.075 -500 Increm. QALY -1000 -1500 ‘Dominant’: 11 1500 1000 500 ICER of 43,700 €/QALY (= 30,000 £/QALY) 2000 1500 1000 500 ICER of 50,000 €/QALY 0 0 -0.075 -0.050 -0.025 -0.000 0.025 0.050 0.075 -0.075 -0.050 -0.025 -0.000 0.025 0.050 0.075 -500 -500 Increm. QALY Increm. QALY -1000 -1000 -1500 52% -2000 Cost effective: Cost savings: 2000 Italy Increm. Cost (€) UK Increm. Cost (€) Increm. Cost (€) France 90% 900 €/pat. FFR is clearly both costsaving and cost-effective -2000 -1500 63% 90% 600 £/pat. -2000 65% 86% 300 €/pat. 1. Siebert U. Cost-Effectiveness and Public Health/Budget-Impact of FFR-Guided PCI in Multivessel Patients in Europe—Analysis of the FAME Study Data. EuroPCR, 2011. BudgetImpact ImpactAnalysis Analysis (example Germany) Budget (example Germany)¹ (€) 0 million -25 million -50 million Best-case Worst-case Mean -75 million -100 million -125 million 0 20 40 60 80 Degree of FFR penetration (%) FFR is both cost-effective and provides a positive budget impact in major European markets 12 1. Siebert U. Cost-Effectiveness and Public Health/Budget-Impact of FFR-Guided PCI in Multivessel Patients in Europe—Analysis of the FAME Study Data. EuroPCR, 2011. 100 Conclusion Average, FFR-guided PCI in patients with multivessel, coronary artery disease and an intermediate stenosis is cost saving and leads to better outcomes than angiography-guided PCI¹ Depending on market uptake, introduction of FFR-guided PCI could lead to: Reduction in death, MI and other major adverse cardiac events Improved quality of life of patients Reductions in expenditure Consistent results across Germany, France, UK and Italy² May be generalized to other Western European countries 1. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-24 2. Siebert U. Cost-Effectiveness and Public Health/Budget-Impact of FFRGuided PCI in Multivessel Patients in Europe—Analysis of the FAME Study Data. EuroPCR, 2011. 13 FAMECost-Effectiveness Cost-Effectiveness Analysis FAME Analysis - Outcomes¹ Outcomes 1. Siebert U. Cost-Effectiveness and Public Health/Budget-Impact of FFRGuided PCI in Multivessel Patients in Europe—Analysis of the FAME Study Data. EuroPCR, 2011. 14 New ESC Guidelines update September 2010 15 FFR Classification Upgraded to IA in the ESC/EACTS Guidelines 16 1. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-24 FFR Strongly Recommended Before Deciding on Treatment The new guidelines support measuring FFR before deciding to perform PCI or send the patient to surgery, in patients who come to the cath lab without a prior functional test and with a stenosis(es) of 50-90% by angiography,1 regardless of whether the patient has singlevessel disease, multivessel disease or if the vessel is especially important (e.g., proximal LAD or LMCA). 17 1. Wijns W, Kolh P, Danchin N, et al. Guidelines on myocardial revascularization: The task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2010;31(20):2501-55. Supported by ACC/AHA/SCAI Guidelines¹ – 2009 The AHA/ACC/SCAI guidelines are Class II A, Level of Evidence A, for determining whether PCI of a specific coronary lesion is warranted. 1. 18 Kushner FG, Hand M, Smith SC Jr, King SB 3rd, et al; 2009 focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update) a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009 Dec 1;54(23):2205-41. Rx Only Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Product referenced is approved for CE Mark. 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