STICH Trial Radionuclide Core Laboratory

DESCRIPTION (provided by applicant):The Surgical Treatment for Ischemic Heart Failure (STICH) multicenterinternational randomized trial addresses two specific primary hypotheses inpatients with clinical heart failure (HF) and left ventricular (LV)dysfunction who have coronary artery disease (CAD) amenable to surgicalrevascularization: 1) Coronary artery bypass grafting (CABG) with intensivemedical therapy (MED) improves long-term survival compared to MED alone;2) In patients with anterior LV dysfunction, surgical ventricular restoration(SVR) to a more normal LV size improves survival free of subsequenthospitalization for cardiac cause in comparison to CABG alone. Importantsecondary endpoints include morbidity, economics, and quality of life. Corelaboratories for cardiac magnetic resonance (CMR), echocardiography (ECHO),neurohormonal/ cytokine/genetic (NCG), and radionuclide (RN) studies willensure consistent testing practices and standardization of data necessary toidentify eligible patients and to address specific questions related to theprimary hypotheses.Over three years, 50 clinical sites will recruit 2,800 consenting patientswith HF, LV ejection fraction (EF) <.35, and CAD amenable to CABG. Thesepatients first will be characterized by angina intensity or presence of leftmain coronary stenosis as appropriate for only surgical therapy or eithermedical or surgical therapy. All patients will be evaluated further forappropriateness of SVR indicated by an end-systolic volume index (ESVI) >60ml/m2 and akinesia >35% of the anterior LV wall. The 600 patients estimatedto be eligible for SVR but ineligible for randomization to medical therapywill be evenly randomized to CABG with or without SVR. Of the 2,200consenting patients eligible for medical or surgical therapy, the 1,600 notSVR eligible will be evenly randomized between MED only and MED with CABG.The remaining 600 patients also eligible for SVR will be randomized betweenthree treatments of MED only, or MED + CABG, or MED + CABG + SVR. Registriesof clinical information will be maintained on eligible patients who declinetrial entry. At four-month intervals for a minimum of three years, allrandomized patients will be followed by a clinical visit and registry patientswill be followed by telephone. Appropriate subgroups of randomized patientswill have core laboratory studies repeated at specified follow-up intervals.In the patients randomized to MED with or without CABG, CABG with MED ishypothesized to demonstrate a >20% reduction in the primary endpoint of all-causedeath with an 89% power from the projected 25% three-year mortality forMED. In the SVR-eligible patients, CABG + SVR is hypothesized to show a 20%advantage with 90% power in the endpoint of survival free of hospitalizationfor cardiac cause projected to be 50% at three years in patients receivingCABG without SVR. Definition of efficacy of potential therapies and theirmechanisms of benefit by the STICH Trial is certain to inform future choice oftherapy and thereby extend and improve the quality of lives of millions ofpatients who now suffer from ischemic HF.