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Saint Luke’s Mid America Heart Institute University of Missouri-Kansas City Kansas City, Missouri

Health Related Quality of Life and U.S. Economic Outcomes of PCI with Drug-Eluting Stents vs. Bypass Surgery: 1-Year Results from the SYNTAX Trial.

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Saint Luke’s Mid America Heart Institute University of Missouri-Kansas City Kansas City, Missouri

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  1. Health Related Quality of Life and U.S. Economic Outcomes of PCI with Drug-Eluting Stents vs. Bypass Surgery: 1-Year Results from the SYNTAX Trial David J. Cohen, Tara A. Lavelle, Patrick W. Serruys, Friedrich W. Mohr, Haiyan Li, Yang Lei, Kaijun Wang, Kate Robertus, Elizabeth M. Mahoney, Yueping Zhu, Keith D. Dawkins, A. Pieter Kappetein on behalf of the SYNTAX Investigators Saint Luke’s Mid America Heart InstituteUniversity of Missouri-Kansas CityKansas City, Missouri

  2. Disclosures SYNTAX was funded by a research grant from Boston Scientific, Inc. SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 2

  3. Background Recently 1-year results from the SYNTAX trial have demonstrated that for patients with left main and/or 3-vessel disease, CABG results in lower rates of MACCE than PCI with DES–- driven by a significant reduction in the need for repeat revascularization Since there were no overall differences in irreversible endpoints, however, quality of life and economic factors should be important considerations in determining the optimal treatment for these highly prevalent conditions To address these issues, both quality of life and health economic analyses were included in the design of the SYNTAX trial SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 3

  4. Methods: Quality of Life Assessments performed by self-administered questionnaires at baseline, 1, 6, and 12 months Primary endpoint: SAQ-Angina Frequency Scale SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 4

  5. Cost-Effectiveness Analysis Analytic Perspective US healthcare system Patient Population All patients with complete 1 yr follow-up, regardless of country of origin General approach Multiply counts of resources derived from trial population by price weights derived from a comparable US population SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 5

  6. Cath lab and OR costs based on measured resource utilization (procedure duration, balloons, stents, wires, etc.) and current unit costs Drug-eluting stent cost =$2000/stent Ancillary hospital costs based on event-based (rather than resource-based) regression models of SYNTAX-eligible U.S. patients using 2006 MedPAR data Avoids distortions due to marked differences in LOS across different health care systems Costs also included for-- other CV and non-CV hospitalizations, MD fees, outpatient CV care/testing, cardiac rehabilitation, and outpatient medications Costing Methods:Revascularization Procedures/Hospitalizations SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 6

  7. Primary Endpoints Total 1-year medical care costs Incremental Cost-Effectiveness Ratio ($/QALY gained) Secondary Endpoints Individual components of cost Disease-specific C/E ratios ($/repeat revascularization avoided, $/death, MI, or stroke avoided) Prespecified Subgroups Left main vs. 3-vessel disease Diabetes SYNTAX score tertiles Economic Analysis Plan SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 7

  8. Baseline QOL P=NS for all comparisons SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 8

  9. Primary QOL Endpoint: SAQ-Angina Frequency ACC 2009 · Orlando, FL · 9

  10. SAQ-AF: Substantial Improvement* * Defined as improvement ≥ 20 points vs. baseline SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 10

  11. SAQ-AF: Angina-Free* * Defined as SAQ-AF score = 100 SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 11

  12. Generic QOL and Utilities SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 12

  13. Initial Hospitalization Costs RevascularizedPopulation ACC 2009 · Orlando, FL · 13

  14. Follow-up Costs Total F/U Costs PCI $8425 CABG $6144 D = $2282 p<0.001 SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 14

  15. Total 1-Year Costs ACC 2009 · Orlando, FL · 15

  16. Cost-Effectiveness of CABG vs. PCI*Overall Population  Cost QALYs  Cost QALYs  Cost QALYs SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 16

  17. Subgroup Analysis: SYNTAX Score Tertiles SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 17

  18. Cost-Effectiveness of CABG vs. PCI ($/QALY)SYNTAX Score Tertiles SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 18

  19. Analysis performed from a US perspective  results likely to differ in other healthcare systems because of differences in patterns of resource use and costs DES cost: US- $2000 UK- $1200 GER- $800 Hosp. day: US- $1500 UK- $400 GER- $320 1-year time horizon does not fully capture differences in long-term survival and QOL 5 yr economic and QOL analyses planned Limitations SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 19

  20. Summary: QOL Among patients undergoing revascularization for left main or 3-vessel CAD, angina relief was slightly better with CABG than DES at 6 and 12 months. The magnitude of benefit was smaller than in previous CABG vs. PCI comparisons, however, and below the threshold that most patients would find clinically meaningful All other QOL endpoints favored PCI at 1 month, although these differences were transient and largely resolved by 6 months SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 20

  21. Summary: Cost-Effectiveness Despite substantially higher procedural costs for PCI, initial treatment costs were ~$6000/pt higher with CABG – mainly due to differences in LOS, complications, and physician costs Follow-up costs were ~$2500/pt lower with CABG, driven largely by differences in the need for additional revascularization procedures and lower medication costs Although total 1-year costs remained significantly lower with PCI, the overall cost-effectiveness of PCI vs. CABG differed substantially according to pt characteristics-– particularly angiographic complexity SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 21

  22. Summary: Cost-Effectiveness (2) Longer-term follow-up is essential (and planned) to fully assess both QOL and cost-effectiveness for these challenging populations SYNTAX · Health Economics/Quality of Life ACC 2009 · Orlando, FL · 22

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