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Financial Disclosures March 31, 2009 Daniel B. Mark, MD, MPH Professor of Medicine Director, Outcomes Research Duke University Medical Center Duke Clinical Research Institute Financial Disclosures Consulting Aventis Astra Zeneca Medtronic, Inc. Novartis Research Grants NIH Proctor & Gamble Pfizer Medtronic, Inc. Alexion Pharmaceuticals Medicure Innocoll St. Jude
Quality of Life and Economic Outcomes with Surgical Ventricular Reconstruction in Symptomatic Heart Failure March 31, 2009 Daniel B. Mark, MD, MPH Duke Clinical Research Institute On behalf of the STICH Economics and Quality of Life Research Team and the STICH Investigators Economics and Quality of Life portion of STICH supported by NHLBI
The Surgical Treatment of Ischemic Heart Failure (STICH) Research Program: Background of SVR Trial ,[object Object],[object Object],[object Object],[object Object]
STICH 1° Hypothesis and Design Overview 1 ° Hypothesis: Adding SVR to CABG in ischemic HF pts will    death/ cardiac rehospitalization 1000 HF pts (2002-2006) CAD, EF  ≤ .35, anterior LV wall scar amenable to SVR 499 CABG only 501 CABG + SVR ,[object Object],[object Object],Median follow-up 48 months
EQOL STICH Baseline Characteristics CABG only (n=499) 62 16% 10% 7% 45% 42% 6% 87% 35% CABG + SVR (n=501) 62 14% 8% 10% 41% 44% 5% 87% 34% Age (mean) Female Race, nonwhite Current NYHA Class   I   II   III   IV Previous MI Diabetes
STICH 1 ° Composite Endpoint: Death or Cardiac Rehospitalization Jones RH et al. NEJM 09
STICH Economics and Quality of Life Study: Key Questions ,[object Object],[object Object]
EQOL STICH: Quality of Life (QOL) Methods Overview ,[object Object],[object Object],[object Object]
EQOL STICH: Selected QOL Assessment Instruments Instrument Kansas City Cardiomyopathy Questionnaire (KCCQ) Seattle Angina Questionnaire SF-36 scales, SF-12 Center for Epidemiologic Studies -Depression (CES-D) Scale Euro-QoL 5D QOL Domain Heart Failure-specific health status Angina symptoms Psychological well-being (MHI-5), role function, social function, vitality, overall health status Depressive symptoms Patient utilities
Kansas City Cardiomyopathy Questionnaire (KCCQ): Overview ,[object Object],[object Object],[object Object],[object Object],Green CP JACC 2000 Spertus J AHJ 2005
STICH QOL 1   Outcome: KCCQ Overall Summary Score P=  .26 P=  .76 P=  .89 CABG CABG + SVR KCCQ Overall Summary  (0-100) Score 0-100 higher = better P=  .53 Clinically significant    >  5 points P=  .89
STICH QOL Outcomes: KCCQ Quality of Life Satisfaction Score P=  .47 P=  .87 P=  .84 KCCQ QOL Score  (0-100) Score 0-100 higher = better P=  .70 Clinically significant    >  5 points P=  .82 CABG CABG + SVR
STICH QOL Outcomes: Seattle Angina Questionnaire- Frequency P=  .74 P=  .77 P=  .46 SAQ Angina Frequency  (0-100) Score 0-100 higher =lower freq P=  .01 Clinically significant    >  5 points P=  .27 CABG CABG + SVR
STICH QOL Outcomes: CES-D  Depression Scale P=  .42 P=  .41 P=  .25 % Depressed P=  .40 P=  .25 CABG CABG + SVR
STICH QOL Outcomes: Other Secondary Comparisons by ITT ,[object Object]
STICH Economic Substudy:   Methods Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
STICH Economic Substudy: Selected Medical Resource Use in US Cohort by ITT CABG 5.7 hours 3.4 days 6.0 days 9.5 days 13.5 days  CABG + SVR 6.8 hours 7.6 days 9.9 days 13.4 days 16.8 days  Resource Use OR time Post-op time in  ICU/CCU Total ICU time Post-op LOS Total LOS P-value <0.001 <0.001 0.0002 <0.001 0.03
STICH Economic Substudy: Selected ICU Medical Resource Use in US Cohort by ITT CABG   17.8% 11.9% 38.6% CABG + SVR 27.6% 32.7% 62.2% Other Resource Use PA catheter IABP for low CO  Inotropes for low CO P-value 0.10 0.0003 0.0008
STICH Economic Substudy: Index Hospitalization Costs in US Cohort by ITT $50,939 $ 5,183 $64,202 $ 6,515 $56,122 $70,717 2008 US Dollars P=0.004 Index Hosp Physician Fees
EQOL STICH: Limitations ,[object Object],[object Object]
STICH Economic and Quality of Life Outcomes: Summary ,[object Object],[object Object],[object Object],[object Object]
American Heart Journal  2009 March 31;0:1-8.e3.
 

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Stich Qol Mark

  • 1. Financial Disclosures March 31, 2009 Daniel B. Mark, MD, MPH Professor of Medicine Director, Outcomes Research Duke University Medical Center Duke Clinical Research Institute Financial Disclosures Consulting Aventis Astra Zeneca Medtronic, Inc. Novartis Research Grants NIH Proctor & Gamble Pfizer Medtronic, Inc. Alexion Pharmaceuticals Medicure Innocoll St. Jude
  • 2. Quality of Life and Economic Outcomes with Surgical Ventricular Reconstruction in Symptomatic Heart Failure March 31, 2009 Daniel B. Mark, MD, MPH Duke Clinical Research Institute On behalf of the STICH Economics and Quality of Life Research Team and the STICH Investigators Economics and Quality of Life portion of STICH supported by NHLBI
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  • 5. EQOL STICH Baseline Characteristics CABG only (n=499) 62 16% 10% 7% 45% 42% 6% 87% 35% CABG + SVR (n=501) 62 14% 8% 10% 41% 44% 5% 87% 34% Age (mean) Female Race, nonwhite Current NYHA Class I II III IV Previous MI Diabetes
  • 6. STICH 1 ° Composite Endpoint: Death or Cardiac Rehospitalization Jones RH et al. NEJM 09
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  • 9. EQOL STICH: Selected QOL Assessment Instruments Instrument Kansas City Cardiomyopathy Questionnaire (KCCQ) Seattle Angina Questionnaire SF-36 scales, SF-12 Center for Epidemiologic Studies -Depression (CES-D) Scale Euro-QoL 5D QOL Domain Heart Failure-specific health status Angina symptoms Psychological well-being (MHI-5), role function, social function, vitality, overall health status Depressive symptoms Patient utilities
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  • 11. STICH QOL 1  Outcome: KCCQ Overall Summary Score P= .26 P= .76 P= .89 CABG CABG + SVR KCCQ Overall Summary (0-100) Score 0-100 higher = better P= .53 Clinically significant  > 5 points P= .89
  • 12. STICH QOL Outcomes: KCCQ Quality of Life Satisfaction Score P= .47 P= .87 P= .84 KCCQ QOL Score (0-100) Score 0-100 higher = better P= .70 Clinically significant  > 5 points P= .82 CABG CABG + SVR
  • 13. STICH QOL Outcomes: Seattle Angina Questionnaire- Frequency P= .74 P= .77 P= .46 SAQ Angina Frequency (0-100) Score 0-100 higher =lower freq P= .01 Clinically significant  > 5 points P= .27 CABG CABG + SVR
  • 14. STICH QOL Outcomes: CES-D Depression Scale P= .42 P= .41 P= .25 % Depressed P= .40 P= .25 CABG CABG + SVR
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  • 17. STICH Economic Substudy: Selected Medical Resource Use in US Cohort by ITT CABG 5.7 hours 3.4 days 6.0 days 9.5 days 13.5 days CABG + SVR 6.8 hours 7.6 days 9.9 days 13.4 days 16.8 days Resource Use OR time Post-op time in ICU/CCU Total ICU time Post-op LOS Total LOS P-value <0.001 <0.001 0.0002 <0.001 0.03
  • 18. STICH Economic Substudy: Selected ICU Medical Resource Use in US Cohort by ITT CABG 17.8% 11.9% 38.6% CABG + SVR 27.6% 32.7% 62.2% Other Resource Use PA catheter IABP for low CO Inotropes for low CO P-value 0.10 0.0003 0.0008
  • 19. STICH Economic Substudy: Index Hospitalization Costs in US Cohort by ITT $50,939 $ 5,183 $64,202 $ 6,515 $56,122 $70,717 2008 US Dollars P=0.004 Index Hosp Physician Fees
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  • 22. American Heart Journal 2009 March 31;0:1-8.e3.
  • 23.