stich qol mark

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 supported Economics and Quality of Life portion of STICH supported by NHLBIby 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 improvement in Observational studies of SVR have shown improvement in HF symptoms and QOLHF symptoms and QOL

• Since SVR almost always done with CABG, unclear what Since SVR almost always done with CABG, unclear what specific incremental benefits the procedure provides. Also, specific incremental benefits the procedure provides. Also, economics of procedure unknown. 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 significantly Does SVR added to CABG significantly improve functioning and well-being in improve functioning and well-being in ischemic heart failure?ischemic heart failure?

• What are the economic implications of What are the economic implications of adding SVR to CABG in patients with adding SVR to CABG in patients with ischemic heart failure?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 statusHeart Failure-specific health status

Angina symptomsAngina symptoms

Psychological well-being (MHI-5), Psychological well-being (MHI-5), role function, social function, vitality, role function, social function, vitality, overall health statusoverall 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

Sum

mar

y (

0-10

0)K

CC

Q O

vera

ll S

umm

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


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


P= .82


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


P= .74 P= .77 P= .46

SA

Q A

ngin

a F

requ

ency

(0

-100

)S

AQ

Ang

ina

Fre

quen

cy

(0-1

00)

Score 0-100Score 0-100higher =lower freqhigher =lower freq

P= .01


P= .27


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


P= .42 P= .41 P= .25

% D

epre

ssed

% D

epre

ssed P= .40

P= .25


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


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%


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.

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