Myocardial Viability - the STICH Trial NEJM May 2011
1. Original Article
Myocardial Viability and Survival in
Ischemic Left Ventricular Dysfunction
Robert O. Bonow, M.D., Gerald Maurer, M.D., Kerry L. Lee, Ph.D., Thomas A.
Holly, M.D., Philip F. Binkley, M.D., Patrice Desvigne-Nickens, M.D., Jaroslaw
Drozdz, M.D., Ph.D., Pedro S. Farsky, M.D., Arthur M. Feldman, M.D., Torsten
Doenst, M.D., Ph.D., Robert E. Michler, M.D., Daniel S. Berman, M.D., Jose C.
Nicolau, M.D., Ph.D., Patricia A. Pellikka, M.D., Krzysztof Wrobel, M.D., Nasri
Alotti, M.D., Ph.D., Federico M. Asch, M.D., Liliana E. Favaloro, M.D., Lilin She,
Ph.D., Eric J. Velazquez, M.D., Robert H. Jones, M.D., and Julio A. Panza, M.D.
for the STICH Trial Investigators
2. Background
Left ventricular dysfunction secondary in patients with
coronary artery disease is not always an irreversible
process
LV function can improve substantially in patients after
CABG
Identifying this subgroup of patients remains the holy
grail of viability research
The common clinical practice of not offering CABG to
patients with LV dysfunction and nonviable scar on
noninvasive studies in not justified by published data
3. Objective
In this substudy of the STICH trial, we report the
outcome of patients who were randomly
assigned to receive medical therapy alone or
medical therapy + CABG who also underwent
assessment of myocardial viability
4. Viability Hypothesis
In this prospective substudy, we tested the
hypothesis that assessment of myocardial
viability identifies patients with CAD and LV
dysfunction who have the greatest survival
benefit with CABG compared to aggressive
medical therapy
5. Study Patients
Patients with angiographic documentation of coronary artery
disease amenable to surgical revascularization and with LV
systolic dysfunction (EF < 35%).
Exclusion criteria - left main coronary artery stenosis fo more
than 50%, cardiogenic shock, myocardial infarction within 3
months, and a need for aortic-valve surgery.
Patients were randomly assigned to receive medical therapy
alone or medical therapy plus CABG.
A risk at randomization (RAR) score was calculated for each
patient with the use of an equation derived in an independent
data set that predicts 5-year risk of death without CABG
6. Study Procedures
Initial design of the STICH trial, viability testing with SPECT was
required for the enrollment of patients
This was eventually expanded to make viability testing optional and
allow the use of either SPECT or dobutamine echocardiography
Investigators at all study centers were strongly encouraged to perform
viability testing in every patient, but the decision to perform the test
was left up to the recruiting investigators
For SPECT, patients with viability were degined as those with 11 or
more viable segments on the basis of relative tracer activity
For dobutamine echo, patients with viability were defined as those with
5 or more segments with abnormal resting systolic function but
manifesting contractile reserve during dobutamine administration
7. Viability Study
SPECT protocols
Thallium-201 stress-redistribution-reinjection
Thallium 201 rest-redistribution
Nitrate-enhanced Tc99m perfusion imaging
Dobutamine echo protocols
Stages increase in dobutamine starting at 5 µg/
kg/min
8. Patient Follow-up and
Outcomes
Patients were followed every 4 months for the first year
and every 6 months thereafter
Primary outcome was death from any cause
Secondary end points
Death from cardiovascular cause
Composite of death from any cause
Hospitalization for cardiovascular causes
Intention-to-treat analysis
9. Results
Of 1212 patient enrolled in the hypothesis 1 comparison, 601 who
underwent assessment of viability were included in the analysis
Differences between two groups
Higher percentage of white patients and lower patients of Asian
patients underwent viability study
Patient in the viability study were more likely
To have hyperlipidemia,
To be on optimal medical therapy,
Have lower LVEF and higher LVEDV and LVESV
Have lower blood pressure
15. Viability and Mortality
During a median of 5.1 years of follow
up
39% of the total population died
51% of deaths occurred in
patients without myocardial
viability
37% of deaths occurred in
patients with viability
However, after adjustment for other
significant baseline prognostic
variables in a multivariate, viability
status was no longer significantly
associated with the rate of death
(p=0.21)
17. Secondary endpoints
Patients with viability also had lower rates of
secondary endpts
Death from CV causes (hazard ratio, 0.61; 95% CI,
0.44 to 0.84; P=0.003)
Not significant on multivariate analysis
Composite of death or hospitlization for CV causes
(hazard ratio, 0.59; 95% CI, 0.47 to 0.74; P<0.001)
Significant on multivariate analysis
20. Study Limitations
Viability study was not performed in enrolled
patients in STICH
Viability studies were limited to dobutamine and
SPECT, while MRI and PET studies were
excluded
21. Conclusions
Study demonstrated a significant association
between myocardial viability and outcome, but
this association was non-siginificant when
subjected to a multivariate analysis
Study failed to demonstrate a significant
interaction between myocardial viability and
medical versus surgical treatment