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Financial DisclosuresFinancial Disclosures
March 31, 2009March 31, 2009
Daniel B. Mark, MD, MPHDaniel B. Mark, MD, MPHProfessor of MedicineProfessor of Medicine
Director, Outcomes ResearchDirector, Outcomes ResearchDuke University Medical CenterDuke University Medical CenterDuke Clinical Research InstituteDuke Clinical Research Institute
Financial DisclosuresFinancial Disclosures
ConsultingConsultingAventisAventisAstra ZenecaAstra ZenecaMedtronic, Inc.Medtronic, Inc.NovartisNovartis
Research GrantsResearch GrantsNIHNIHProctor & GambleProctor & GamblePfizerPfizerMedtronic, Inc.Medtronic, Inc.
Alexion PharmaceuticalsAlexion PharmaceuticalsMedicureMedicureInnocollInnocollSt. JudeSt. Jude
Quality of Life and Economic Outcomes with Surgical Quality of Life and Economic Outcomes with Surgical Ventricular Reconstruction in Symptomatic Heart FailureVentricular Reconstruction in Symptomatic Heart Failure
March 31, 2009March 31, 2009
Daniel B. Mark, MD, MPHDaniel B. Mark, MD, MPHDuke Clinical Research InstituteDuke Clinical Research Institute
On behalf of the STICH Economics and Quality of LifeOn behalf of the STICH Economics and Quality of LifeResearch Team and the STICH InvestigatorsResearch Team and the STICH Investigators
Economics and Quality of Life portion of STICH Economics and Quality of Life portion of STICH supported by NHLBIsupported by NHLBI
The Surgical Treatment of Ischemic Heart Failure The Surgical Treatment of Ischemic Heart Failure (STICH) Research Program: Background of SVR Trial(STICH) Research Program: Background of SVR Trial
• Subset of ischemic cardiomyopathy pts develop Subset of ischemic cardiomyopathy pts develop progressive HF due to adverse LV remodelingprogressive HF due to adverse LV remodeling
• Surgical ventricular reconstruction (SVR) is novel Surgical ventricular reconstruction (SVR) is novel procedure to procedure to LV size, create more normal LV shape LV size, create more normal LV shape
• Observational studies of SVR have shown Observational studies of SVR have shown improvement in HF symptoms and QOLimprovement in HF symptoms and QOL
• Since SVR almost always done with CABG, unclear Since SVR almost always done with CABG, unclear what specific incremental benefits the procedure what specific incremental benefits the procedure provides. Also, economics of procedure unknown. provides. Also, economics of procedure unknown.
STICH 1° Hypothesis and Design OverviewSTICH 1° Hypothesis and Design Overview
11° Hypothesis: Adding SVR to CABG in ischemic HF pts will ° Hypothesis: Adding SVR to CABG in ischemic HF pts will death/ cardiac rehospitalizationdeath/ cardiac rehospitalization
1000 HF pts (2002-2006)1000 HF pts (2002-2006)CAD, EF CAD, EF ≤ .35, anterior LV ≤ .35, anterior LV wall scar amenable to SVRwall scar amenable to SVR
499499CABG onlyCABG only
501501CABG + SVRCABG + SVR
• 7% did not receive 7% did not receive operationoperation
• 9% did not receive 9% did not receive operationoperation
Median follow-upMedian follow-up48 months48 months
EQOL STICH Baseline CharacteristicsEQOL STICH Baseline Characteristics
CABG onlyCABG only
(n=499)(n=499)
6262
16%16%
10%10%
7%7%45%45%42%42%6%6%
87%87%
35%35%
CABG + SVRCABG + SVR
(n=501)(n=501)
6262
14%14%
8%8%
10%10%41%41%44%44%5%5%
87%87%
34%34%
Age (mean)Age (mean)
FemaleFemale
Race, nonwhiteRace, nonwhite
Current NYHA ClassCurrent NYHA Class I I II II III III IV IV
Previous MIPrevious MI
DiabetesDiabetes
STICH 1STICH 1° Composite Endpoint:° Composite Endpoint:Death or Cardiac RehospitalizationDeath or Cardiac Rehospitalization
Jones RH et al.Jones RH et al.NEJM 09NEJM 09
STICH Economics and Quality of Life Study:STICH Economics and Quality of Life Study:Key QuestionsKey Questions
• Does SVR added to CABG Does SVR added to CABG significantly improve functioning and significantly improve functioning and well-being in ischemic heart failure?well-being in ischemic heart failure?
• What are the economic implications What are the economic implications of adding SVR to CABG in patients of adding SVR to CABG in patients with ischemic heart failure?with ischemic heart failure?
EQOL STICH:EQOL STICH:Quality of Life (QOL) Methods OverviewQuality of Life (QOL) Methods Overview
• QOL structured interviews at baseline and QOL structured interviews at baseline and 4, 12, 24, and 36 months post-4, 12, 24, and 36 months post-randomizationrandomization
• 991 (99%) of 1000 main STICH pts in QOL991 (99%) of 1000 main STICH pts in QOL
• 4136 (92%) expected QOL contacts 4136 (92%) expected QOL contacts collectedcollected
EQOL STICH:EQOL STICH:Selected QOL Assessment InstrumentsSelected QOL Assessment Instruments
InstrumentInstrument
Kansas City CardiomyopathyKansas City CardiomyopathyQuestionnaire (KCCQ)Questionnaire (KCCQ)
Seattle Angina QuestionnaireSeattle Angina Questionnaire
SF-36 scales, SF-12SF-36 scales, SF-12
Center for Epidemiologic StudiesCenter for Epidemiologic Studies-Depression (CES-D) Scale-Depression (CES-D) Scale
Euro-QoL 5DEuro-QoL 5D
QOL DomainQOL Domain
Heart Failure-specific health Heart Failure-specific health statusstatus
Angina symptomsAngina symptoms
Psychological well-being (MHI-5), Psychological well-being (MHI-5), role function, social function, role function, social function, vitality, overall health statusvitality, overall health status
Depressive symptomsDepressive symptoms
Patient utilitiesPatient utilities
Kansas City Cardiomyopathy Questionnaire Kansas City Cardiomyopathy Questionnaire (KCCQ): Overview(KCCQ): Overview
• 23-item disease specific QOL assessment 23-item disease specific QOL assessment instrumentinstrument
• Used to measure effects of heart failure Used to measure effects of heart failure symptoms on functional limitations, social symptoms on functional limitations, social limitations, self efficacy, and patient satisfaction limitations, self efficacy, and patient satisfaction with overall QOLwith overall QOL
• Overall summary score plus 6 component scoresOverall summary score plus 6 component scores
• Scores 1-100 (higher=better), difference Scores 1-100 (higher=better), difference >> 5 5 points clinically significantpoints clinically significant
Green CP JACC 2000Spertus J AHJ 2005
STICH QOL 1STICH QOL 1 Outcome: Outcome:KCCQ Overall Summary ScoreKCCQ Overall Summary Score
53
7984 84 85
54
79 82 84 84
0
20
40
60
80
100
Baseline 4 Mos 12 Mos 24 Mos 36 Mos
P= .26P= .76 P= .89
CABGCABGCABG + SVRCABG + SVR
KC
CQ
Ove
rall
Su
mm
ary
(0-
100)
KC
CQ
Ove
rall
Su
mm
ary
(0-
100)
Score 0-100Score 0-100higher = betterhigher = better
P= .53
Clinically significantClinically significant >> 5 points 5 points
P= .89
STICH QOL Outcomes:STICH QOL Outcomes:KCCQ Quality of Life Satisfaction ScoreKCCQ Quality of Life Satisfaction Score
42
75 75 75 75
33
75 75 7583
0
20
40
60
80
100
Baseline 4 Mos 12 Mos 24 Mos 36 Mos
P= .47 P= .87 P= .84
KC
CQ
QO
L S
core
(0
-100
)K
CC
Q Q
OL
Sco
re
(0-1
00)
Score 0-100Score 0-100higher = betterhigher = better
P= .70
Clinically significantClinically significant >> 5 points 5 points
P= .82
CABGCABGCABG + SVRCABG + SVR
STICH QOL Outcomes:STICH QOL Outcomes:Seattle Angina Questionnaire- FrequencySeattle Angina Questionnaire- Frequency
70
100 100 100 100
80
100 100 100 100
0
20
40
60
80
100
Baseline 4 Mos 12 Mos 24 Mos 36 Mos
P= .74 P= .77 P= .46
SA
Q A
ng
ina
Fre
qu
ency
(0
-100
)S
AQ
An
gin
a F
req
uen
cy
(0-1
00)
Score 0-100Score 0-100higher =lower freqhigher =lower freq
P= .01
Clinically significantClinically significant >> 5 points 5 points
P= .27
CABGCABGCABG + SVRCABG + SVR
STICH QOL Outcomes:STICH QOL Outcomes:CES-D Depression ScaleCES-D Depression Scale
51
3024
2821
53
27 27 24 25
0
20
40
60
80
100
Baseline 4 Mos 12 Mos 24 Mos 36 Mos
P= .42 P= .41 P= .25
% D
epre
ssed
% D
epre
ssed P= .40
P= .25
CABGCABGCABG + SVRCABG + SVR
STICH QOL Outcomes:STICH QOL Outcomes:Other Secondary Comparisons by ITTOther Secondary Comparisons by ITT
• No treatment-related difference in:No treatment-related difference in:
Additional KCCQ subscalesAdditional KCCQ subscalesAdditional SAQ scalesAdditional SAQ scalesSF-12 Physical and Mental ComponentsSF-12 Physical and Mental ComponentsSF-36 subscalesSF-36 subscalesCardiac Self-EfficacyCardiac Self-Efficacy0-100 self rating0-100 self ratingEuro-QoLEuro-QoL
STICH Economic Substudy: STICH Economic Substudy: Methods Overview Methods Overview
• Resource use data from CRF and medical billsResource use data from CRF and medical bills
• Bills collected on 196 of 200 (98%) U.S. patientsBills collected on 196 of 200 (98%) U.S. patients
• Costs estimated using hospital bills, Medicare Costs estimated using hospital bills, Medicare correction factors, and Medicare fee schedulecorrection factors, and Medicare fee schedule
• Outpatient care, medications, productivity costs, Outpatient care, medications, productivity costs, non-medical costs not includednon-medical costs not included
• Cost effectiveness not performed (SVR arm not Cost effectiveness not performed (SVR arm not clinically superior to CABG alone)clinically superior to CABG alone)
• Results reported in 2008 US$Results reported in 2008 US$
STICH Economic Substudy:STICH Economic Substudy:Selected Medical Resource Use in US Cohort by ITTSelected Medical Resource Use in US Cohort by ITT
CABGCABG
5.7 hours5.7 hours
3.4 days3.4 days
6.0 days6.0 days
9.5 days9.5 days
13.5 days 13.5 days
CABG + SVRCABG + SVR
6.8 hours6.8 hours
7.6 days7.6 days
9.9 days9.9 days
13.4 days13.4 days
16.8 days 16.8 days
Resource UseResource Use
OR timeOR time
Post-op time in Post-op time in ICU/CCUICU/CCU
Total ICU timeTotal ICU time
Post-op LOSPost-op LOS
Total LOSTotal LOS
P-valueP-value
<0.001<0.001
<0.001<0.001
0.00020.0002
<0.001<0.001
0.03 0.03
STICH Economic Substudy:STICH Economic Substudy:Selected ICU Medical Resource Use in US Cohort by ITTSelected ICU Medical Resource Use in US Cohort by ITT
CABGCABG
17.8%17.8%
11.9%11.9%
38.6%38.6%
CABG + SVRCABG + SVR
27.6%27.6%
32.7%32.7%
62.2%62.2%
Other Resource UseOther Resource Use
PA catheterPA catheter
IABP for low CO IABP for low CO
Inotropes for low COInotropes for low CO
P-valueP-value
0.100.10
0.00030.0003
0.00080.0008
STICH Economic Substudy:STICH Economic Substudy:Index Hospitalization Costs in US Cohort by ITTIndex Hospitalization Costs in US Cohort by ITT
$0
$10,000
$20,000
$30,000
$40,000
$50,000
$60,000
$70,000
$80,000
CABG CABG + SVR
$50,939
$ 5,183
$64,202
$ 6,515$56,122$56,122
$70,717$70,717
2008 US Dollars2008 US Dollars P=0.004P=0.004
Index HospIndex Hosp
Physician FeesPhysician Fees
EQOL STICH:EQOL STICH:LimitationsLimitations
• Unblinded treatment assignment, Unblinded treatment assignment, participation in RCT may distort careparticipation in RCT may distort care
• Resource use and cost patterns seen in Resource use and cost patterns seen in the U.S. cohort do not reflect patterns in the U.S. cohort do not reflect patterns in other participating countriesother participating countries
STICH Economic and Quality of Life Outcomes:STICH Economic and Quality of Life Outcomes:SummarySummary
• STICH is first RCT comparing 2 cardiac surgical STICH is first RCT comparing 2 cardiac surgical treatment strategiestreatment strategies
• Adding SVR to CABG does not provide any Adding SVR to CABG does not provide any incremental improvements in QOL out to 3 years incremental improvements in QOL out to 3 years post-surgerypost-surgery
• SVR SVR ↑ complexity of post-operative care and ↑ complexity of post-operative care and significantly ↑ costs of the procedure over CABG significantly ↑ costs of the procedure over CABG alonealone
• No benefit for continued routine use of this No benefit for continued routine use of this procedure in STICH-eligible ptsprocedure in STICH-eligible pts
American Heart JournalAmerican Heart Journal 2009 March 31;0:1-8.e3. 2009 March 31;0:1-8.e3.