Transcript Quality of Life and Economic Outcomes with

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.
March 31, 2009
Alexion Pharmaceuticals
Medicure
Innocoll
St. Jude
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
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.
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
Median follow-up
48 months
499
CABG only
501
CABG + SVR
• 7% did not receive
operation
• 9% did not receive
operation
EQOL STICH Baseline Characteristics
CABG only CABG + SVR
(n=499)
(n=501)
62
62
Female
16%
14%
Race, nonwhite
10%
8%
Current NYHA Class
I
II
III
IV
7%
45%
42%
6%
10%
41%
44%
5%
Previous MI
87%
87%
Diabetes
35%
34%
Age (mean)
STICH 1° Composite Endpoint:
Death or Cardiac Rehospitalization
Jones RH et al.
NEJM 09
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?
EQOL STICH:
Quality of Life (QOL) Methods Overview
• QOL structured interviews at baseline and
4, 12, 24, and 36 months postrandomization
• 991 (99%) of 1000 main STICH pts in QOL
• 4136 (92%) expected QOL contacts
collected
EQOL STICH:
Selected QOL Assessment Instruments
Instrument
QOL Domain
Kansas City Cardiomyopathy
Questionnaire (KCCQ)
Heart Failure-specific health
status
Seattle Angina Questionnaire
Angina symptoms
SF-36 scales, SF-12
Psychological well-being (MHI-5),
role function, social function,
vitality, overall health status
Center for Epidemiologic Studies
-Depression (CES-D) Scale
Depressive symptoms
Euro-QoL 5D
Patient utilities
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 1-100 (higher=better), difference > 5
points clinically significant
Green CP JACC 2000
Spertus J AHJ 2005
KCCQ Overall Summary (0-100)
STICH QOL 1 Outcome:
KCCQ Overall Summary Score
100
80
60
P= .26
79
79
P= .76
84
82
P= .89
P= .89
84
85
84
84
P= .53
53
54
40
20
0
Baseline
4 Mos
CABG
CABG + SVR
12 Mos
24 Mos
Score 0-100
higher = better
36 Mos
Clinically significant
 > 5 points
STICH QOL Outcomes:
KCCQ Quality of Life Satisfaction Score
P= .82
KCCQ QOL Score (0-100)
100
P= .47
75
80
60
75
P= .87
P= .84
83
75
75
75
75
75
P= .70
42
40
33
20
0
Baseline
4 Mos
CABG
CABG + SVR
12 Mos
Score 0-100
higher = better
24 Mos
36 Mos
Clinically significant
 > 5 points
SAQ Angina Frequency (0-100)
STICH QOL Outcomes:
Seattle Angina Questionnaire- Frequency
100
80
P= .01
P= .74
100 100
P= .77
100 100
P= .46
100 100
P= .27
100 100
4 Mos
12 Mos
24 Mos
36 Mos
80
70
60
40
20
0
Baseline
CABG
CABG + SVR
Score 0-100
higher =lower freq
Clinically significant
 > 5 points
STICH QOL Outcomes:
CES-D Depression Scale
100
% Depressed
80
P= .40
60
51
53
P= .42
40
30
27
P= .41
24
27
P= .25
28
24
P= .25
21
25
20
0
Baseline
4 Mos
CABG
CABG + SVR
12 Mos
24 Mos
36 Mos
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
0-100 self rating
Euro-QoL
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$
STICH Economic Substudy:
Selected Medical Resource Use in US Cohort by ITT
CABG
CABG + SVR
P-value
OR time
5.7 hours
6.8 hours
<0.001
Post-op time in
ICU/CCU
3.4 days
7.6 days
<0.001
Total ICU time
6.0 days
9.9 days
0.0002
Post-op LOS
9.5 days
13.4 days
<0.001
13.5 days
16.8 days
0.03
Resource Use
Total LOS
STICH Economic Substudy:
Selected ICU Medical Resource Use in US Cohort by ITT
CABG
CABG + SVR
P-value
PA catheter
17.8%
27.6%
0.10
IABP for low CO
11.9%
32.7%
0.0003
Inotropes for low CO
38.6%
62.2%
0.0008
Other Resource Use
STICH Economic Substudy:
Index Hospitalization Costs in US Cohort by ITT
2008 US Dollars
P=0.004
$80,000
$70,000
$70,717
$56,122
$ 6,515
$60,000
$50,000
$40,000
$30,000
Physician Fees
$ 5,183
Index Hosp
$50,939
$64,202
CABG
CABG + SVR
$20,000
$10,000
$0
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
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
American Heart Journal 2009 March 31;0:1-8.e3.