Myocardial Viability - the STICH Trial NEJM May 2011
Original ArticleMyocardial Viability and Survival inIschemic 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
BackgroundLeft ventricular dysfunction secondary in patients withcoronary artery disease is not always an irreversibleprocess LV function can improve substantially in patients after CABGIdentifying this subgroup of patients remains the holygrail of viability researchThe common clinical practice of not offering CABG topatients with LV dysfunction and nonviable scar onnoninvasive studies in not justified by published data
ObjectiveIn this substudy of the STICH trial, we report theoutcome of patients who were randomlyassigned to receive medical therapy alone ormedical therapy + CABG who also underwentassessment of myocardial viability
Viability HypothesisIn this prospective substudy, we tested thehypothesis that assessment of myocardialviability identifies patients with CAD and LVdysfunction who have the greatest survivalbenefit with CABG compared to aggressivemedical therapy
Study PatientsPatients with angiographic documentation of coronary arterydisease amenable to surgical revascularization and with LVsystolic dysfunction (EF < 35%).Exclusion criteria - left main coronary artery stenosis fo morethan 50%, cardiogenic shock, myocardial infarction within 3months, and a need for aortic-valve surgery.Patients were randomly assigned to receive medical therapyalone or medical therapy plus CABG.A risk at randomization (RAR) score was calculated for eachpatient with the use of an equation derived in an independentdata set that predicts 5-year risk of death without CABG
Study ProceduresInitial design of the STICH trial, viability testing with SPECT wasrequired for the enrollment of patients This was eventually expanded to make viability testing optional and allow the use of either SPECT or dobutamine echocardiographyInvestigators at all study centers were strongly encouraged to performviability testing in every patient, but the decision to perform the testwas left up to the recruiting investigatorsFor SPECT, patients with viability were degined as those with 11 ormore viable segments on the basis of relative tracer activityFor dobutamine echo, patients with viability were defined as those with5 or more segments with abnormal resting systolic function butmanifesting contractile reserve during dobutamine administration
Patient Follow-up andOutcomesPatients were followed every 4 months for the first yearand every 6 months thereafterPrimary outcome was death from any causeSecondary end points Death from cardiovascular cause Composite of death from any cause Hospitalization for cardiovascular causesIntention-to-treat analysis
ResultsOf 1212 patient enrolled in the hypothesis 1 comparison, 601 whounderwent assessment of viability were included in the analysisDifferences 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
Viability and MortalityDuring a median of 5.1 years of followup 39% of the total population died 51% of deaths occurred in patients without myocardial viability 37% of deaths occurred in patients with viabilityHowever, after adjustment for othersignificant baseline prognosticvariables in a multivariate, viabilitystatus was no longer significantlyassociated with the rate of death(p=0.21)
Secondary endpointsPatients with viability also had lower rates ofsecondary 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
Study LimitationsViability study was not performed in enrolledpatients in STICHViability studies were limited to dobutamine andSPECT, while MRI and PET studies wereexcluded
ConclusionsStudy demonstrated a significant associationbetween myocardial viability and outcome, butthis association was non-siginificant whensubjected to a multivariate analysisStudy failed to demonstrate a significantinteraction between myocardial viability andmedical versus surgical treatment
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