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Myocardial Viability and Survival in Ischemic Left Ventricular Dysfunction Robert O. Bonow, MD April 4, 2011 On behalf of the STICH Trial Investigators PowerPoint PPT Presentation


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Myocardial Viability and Survival in Ischemic Left Ventricular Dysfunction Robert O. Bonow, MD April 4, 2011 On behalf of the STICH Trial Investigators. STICH Financial Disclosures. Background.

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Myocardial Viability and Survival in Ischemic Left Ventricular Dysfunction Robert O. Bonow, MD April 4, 2011 On behalf of the STICH Trial Investigators

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Myocardial Viability and Survival

in Ischemic Left Ventricular Dysfunction

Robert O. Bonow, MD

April 4, 2011

On behalf of the STICH Trial Investigators


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STICH Financial Disclosures


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Background

  • LV dysfunction in patients with CAD is not always an irreversible process, as LV function may improve substantially after CABG

  • Assessment of myocardial viability is often used to predict improvement in LV function after CABG and thus select patients for CABG

  • Numerous studies have suggested that identification of viable myocardium also predicts improved survival after CABG


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Limitations of Cohort Studies

  • Decision for CABG may have been influenced by viability status

  • No (or inadequate) adjustment for key baseline variables (age, comorbidities)

  • Cohort studies carried out before modern aggressive medical therapy


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STICH Revascularization Hypothesis

  • The first prospective randomized trial testing the hypothesis that CABG improves survival in patients with ischemic LV dysfunction compared to outcome with aggressive medical therapy

  • Provides the first opportunity to assess the interaction between myocardial viability and survival in randomized patients who were all eligible for medical management alone and eligible for CABG.


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STICH Revascularization Hypothesis

  • Hypothesis of viability testing:

  • In patients with CAD and LV dysfunction, assessment of myocardial viability will identify those patients who will have the greatest survival benefit from adding CABG to aggressive medical therapy


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STICH Revascularization Hypothesis

Viability testing:

  • All randomized patients were eligible for viability testing with SPECT myocardial perfusion imaging or dobutamine echo.

  • Viability testing was optional at enrolling sites using established SPECT and DE viability protocols.


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STICH Revascularization Hypothesis

  • SPECT protocols:

  • Thallium-201 stress-redistribution-reinjection

  • Thallium-201 rest-redistribution

  • Nitrate-enhanced Tc-99m perfusion imaging

  • Dobutamine echo protocols:

  • Staged increase in dobutamine starting at 5 μg/kg/min

  • Prespecified definition of viability:

  • SPECT: 17 segment model; ≥11 segments manifesting

  • viability based on relative tracer activity

  • DE: 16 segment model; ≥5 segments with dysfunction

  • at rest manifesting contractile reserve with dobutamine


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STICH Revascularization Hypothesis

Primary endpoint:

▪ All-cause mortality

Secondary endpoints:

▪ Mortality plus cardiovascular hospitalization

▪ Cardiovascular mortality

Intention-to-treat analysis


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Patients randomized in STICH Revascularization Hypothesis

1212

Patients with myocardial

viability test

Patients with no myocardial viability test

594

618

Unusable test

• Timing

• Poor quality

Patients with no usable myocardial viability test

17

611

Patients with usable myocardial

viability test

601


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Patients randomized in STICH Revascularization Hypothesis

1212

SPECT

n=471

Dobutamine echo

n=280

150

321

130

Patients with no usable myocardial viability test

611

Patients with usable myocardial

viability test

601

114

Nonviable

487

Viable


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Baseline Characteristics

Patients With and Without Myocardial Viability

*

*

Significant covariates in risk model: Age, renal function, heart failure,

ejection fraction, CAD index, mitral regurgitation, stroke


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Baseline Characteristics

Patients With and Without Myocardial Viability

LVEF

LVEDVI

LVESVI

Previous MI

p<0.001

p<0.001

p<0.001

p<0.001

100

50

200

180

80

40

160

140

30

120

60

100

Percent

Ejection Fraction (%)

LV Volume Index (ml / m2)

40

20

80

60

20

10

40

20

0

0

0

With myocardial viability

Without myocardial viability


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Myocardial Viability and Mortality

1.0

Without viability

With viability

Variables associated with mortality

0.8

HR 95% CI P

0.64 0.48,0.86 0.003

0.6

Mortality Rate

0.4

0.2

0.0

0

1

2

3

4

5

6

Years from Randomization

Without viability

With viability

114 99 85 80 63 36 16

487 432 409 371 294 188 102


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Myocardial Viability and Mortality


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Myocardial Viability and Cardiovascular Mortality

1.0

Without viability

With viability

0.8

HR 95% CI P

0.61 0.44,0.84 0.003

0.6

Cardiovascular Mortality Rate

0.4

0.2

0.0

0

1

2

3

4

5

6

Years from Randomization

Without viability

With viability

114 99 85 80 63 36 16

487 432 409 371 294 188 102


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Myocardial Viability and Mortality + CV Hospitalization

1.0

Without viability

With viability

0.8

HR 95% CI P

0.59 0.47,0.44 <0.001

0.6

Mortality and CV Hospitalization Rate

0.4

HR 95% CI P

0.59 0.47,0.44 <0.001

0.2

0.0

0

1

2

3

4

5

6

Years from Randomization

Without viability

With viability

114 56 41 34 22 14 5

487 327 284 238 166 94 41


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Patients with

viability tests

601

Patients with myocardial viability

487

114

Patients without myocardial viability

243

244

60

54

CABG

47.4%

MED

49.9%

CABG

50.1%

MED

52.6%


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Baseline Characteristics

*

*

*

Significant covariates in risk model: Age, renal function,

heart failure, ejection fraction, CAD index, MR, stroke


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Myocardial Viability and Mortality

Without Viability

With Viability

1.0

MED (95 deaths)

CABG (83 deaths)

MED (33 deaths)

CABG (25 deaths)

0.8

0.6

Mortality Rate

0.4

0.2

0.0

0

1

2

3

4

5

6

0

1

2

3

4

5

6

Years from Randomization

Years from Randomization

MED

CABG

60 51 44 39 29 14 4 243 219 206 179 146 94 51

54 48 41 41 34 22 12 244 213 203 192 148 94 51


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Myocardial Viability and Mortality

Without Viability

With Viability

1.0

MED (95 deaths)

CABG (83 deaths)

MED (33 deaths)

CABG (25 deaths)

0.8

0.6

Mortality Rate

0.4

0.2

0.0

0

1

2

3

4

5

6

0

1

2

3

4

5

6

Years from Randomization

Years from Randomization

Subgroup

Without viability

With viability

N Deaths HR 95% CI

114 58 0.70 0.41, 1.18

487 178 0.86 0.64, 1.16

Interaction

P value

0.528

0.25

0.5

1

2

CABG

better

MED

better


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Interaction of Viability and Treatment on CV Outcomes


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Limitations

  • Lack of viability data on all patients; patients represent a subpopulation of STICH

  • Analysis limited to SPECT and DE, not PET or cardiac MRI

  • Fundamental differences in viability information provided by SPECT and DE, and differences in analytic methods between the two methods


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STICH Revascularization Hypothesis

  • STICH represents the largest report to date relating myocardial viability to clinical outcomes of patients with CAD and LV dysfunction

  • … and is the first to assess these relationships prospectively among patients who were all eligible for CABG as well as optimal medical management alone


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STICH Revascularization Hypothesis

STICH results:

  • …demonstrate a significant association between myocardial viability and outcome, but this association is rendered non-significant when subjected to a multivariable analysis that includes other prognostic variables.

  • …fail to demonstrate a significant interaction between myocardial viability and medical versus surgical treatment with respect to mortality, whether assessed according to treatment assigned (intention to treat) or to the treatment actually received.


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STICH Revascularization Hypothesis

  • Implications of STICH:

  • In patients with CAD and LV dysfunction, assessment of myocardial viability does not identify patients who will have the greatest survival benefit from adding CABG to aggressive medical therapy

Full report available at www.NEJM.org


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