1. Financial Disclosures
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
March 31, 2009

2. Quality of Life and Economic Outcomes with Surgical Ventricular Reconstruction in Symptomatic Heart Failure
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
March 31, 2009

3. The Surgical Treatment of Ischemic Heart Failure (STICH) Research Program: Background of SVR Trial
Subset of ischemic cardiomyopathy pts develop progressive HF due to adverse LV remodeling
Surgical ventricular reconstruction (SVR) is novel procedure to  LV size, create more normal LV shape
Observational studies of SVR have shown improvement in HF symptoms and QOL
Since SVR almost always done with CABG, unclear what specific incremental benefits the procedure provides. Also, economics of procedure unknown.

4. STICH 1° Hypothesis and Design Overview
1° Hypothesis: Adding SVR to CABG in ischemic HF pts will  death/ cardiac rehospitalization
1000 HF pts ( )
CAD, EF ≤ .35, anterior LV wall scar amenable to SVR
499
CABG only
501
CABG + SVR
Median follow-up
48 months
7% did not receive operation
9% did not receive operation

5. EQOL STICH Baseline Characteristics
Age (mean)
Female
Race, nonwhite
Current NYHA Class I II III IV
Previous MI
Diabetes
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%

6. STICH 1° Composite Endpoint: Death or Cardiac Rehospitalization
Jones RH et al.
NEJM 09

7. STICH Economics and Quality of Life Study: Key Questions
Does SVR added to CABG significantly improve functioning and well-being in ischemic heart failure?
What are the economic implications of adding SVR to CABG in patients with ischemic heart failure?

8. EQOL STICH: Quality of Life (QOL) Methods Overview
QOL structured interviews at baseline and 4, 12, 24, and 36 months post-randomization
991 (99%) of 1000 main STICH pts in QOL
4136 (92%) expected QOL contacts collected

9. EQOL STICH: Selected QOL Assessment Instruments
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

10. Kansas City Cardiomyopathy Questionnaire (KCCQ): Overview
23-item disease specific QOL assessment instrument
Used to measure effects of heart failure symptoms on functional limitations, social limitations, self efficacy, and patient satisfaction with overall QOL
Overall summary score plus 6 component scores
Scores (higher=better), difference > 5 points clinically significant
Green CP JACC 2000
Spertus J AHJ 2005

11. STICH QOL 1 Outcome: KCCQ Overall Summary Score
P= .76
P= .89
P= .89
P= .26
P= .53
KCCQ Overall Summary (0-100)
CABG
Score 0-100
higher = better
Clinically significant
 > 5 points
CABG + SVR

12. STICH QOL Outcomes: KCCQ Quality of Life Satisfaction Score
P= .82
P= .87
P= .84
P= .47
P= .70
KCCQ QOL Score (0-100)
CABG
Score 0-100
higher = better
Clinically significant
 > 5 points
CABG + SVR

13. STICH QOL Outcomes: Seattle Angina Questionnaire- Frequency
P= .74
P= .77
P= .46
P= .27
P= .01
SAQ Angina Frequency (0-100)
CABG
Score 0-100
higher =lower freq
Clinically significant
 > 5 points
CABG + SVR

14. STICH QOL Outcomes: CES-D Depression Scale
% Depressed
P= .42
P= .41
P= .25
P= .25
CABG
CABG + SVR

15. STICH QOL Outcomes: Other Secondary Comparisons by ITT
No treatment-related difference in: Additional KCCQ subscales Additional SAQ scales SF-12 Physical and Mental Components SF-36 subscales Cardiac Self-Efficacy self rating Euro-QoL

16. STICH Economic Substudy: Methods Overview
Resource use data from CRF and medical bills
Bills collected on 196 of 200 (98%) U.S. patients
Costs estimated using hospital bills, Medicare correction factors, and Medicare fee schedule
Outpatient care, medications, productivity costs, non-medical costs not included
Cost effectiveness not performed (SVR arm not clinically superior to CABG alone)
Results reported in 2008 US$

17. STICH Economic Substudy: Selected Medical Resource Use in US Cohort by ITT
OR time
Post-op time in ICU/CCU
Total ICU time
Post-op LOS
Total LOS
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
P-value
<0.001
0.0002
0.03

18. STICH Economic Substudy: Selected ICU Medical Resource Use in US Cohort by ITT
Other Resource Use
PA catheter
IABP for low CO
Inotropes for low CO
CABG
17.8%
11.9%
38.6%
CABG + SVR
27.6%
32.7%
62.2%
P-value
0.10
0.0003
0.0008

19. STICH Economic Substudy: Index Hospitalization Costs in US Cohort by ITT
2008 US Dollars
P=0.004
$70,717
$56,122
$ 6,515
Physician Fees
$ 5,183
Index Hosp
$50,939
$64,202

20. EQOL STICH: Limitations
Unblinded treatment assignment, participation in RCT may distort care
Resource use and cost patterns seen in the U.S. cohort do not reflect patterns in other participating countries

21. STICH Economic and Quality of Life Outcomes: Summary
STICH is first RCT comparing 2 cardiac surgical treatment strategies
Adding SVR to CABG does not provide any incremental improvements in QOL out to 3 years post-surgery
SVR ↑ complexity of post-operative care and significantly ↑ costs of the procedure over CABG alone
No benefit for continued routine use of this procedure in STICH-eligible pts

22. American Heart Journal 2009 March 31;0:1-8.e3.