The Surgical Treatment for Ischemic Heart Failure (STICH) multicenter international randomized trial addresses two specific primary hypotheses in patients with clinical heart failure (HF) and left ventricular (LV) dysfunction who have coronary artery disease (CAD) amenable to surgical revascularization: 1) Coronary artery bypass grafting (CABG) with intensive medical 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 subsequent hospitalization for cardiac cause in comparison to CABG alone. Important secondary endpoints include morbidity, economics, and quality of life. Core laboratories for cardiac magnetic resonance (CMR), echocardiography (ECHO), neurohormonal/cytokine/genetic (NCG), and radionuclide (RN) studies will insure consistent testing practices and standardization of data necessary to identify eligible patients and to address specific questions related to the primary hypotheses. Over three years, 50 clinical sites will recruit 2,800 consenting patients with HF, LV ejection fraction (EF) < .35, and CAD amenable to CABG. These patients first will be characterized by angina intensity or presence of left main coronary stenosis as appropriate for only surgical therapy or either medical or surgical therapy. All patients will be evaluated further for appropriateness of SVR indicated by an end-systolic volume index (ESVI) > 60 ml/m2 and akinesia >35% of the anterior LV wall. The 600 patients estimated to be eligible for SVR but ineligible for randomization to medical therapy will be evenly randomized to CABG with or without SVR. Of the 2,200 consenting patients eligible for medical or surgical therapy, the 1,600 not SVR eligible will be evenly randomized between MED only and MED with CABG. The remaining 600 patients also eligible for SVR will be randomized between three treatments of MED only, or MED + CABG, or MED + CABG + SVR. Registries of clinical information will be maintained on eligible patients who decline trial entry. At four- month intervals for a minimum of three years, all randomized patients will be followed by a clinic visit and registry patients will be followed by telephone. Appropriate subgroups of randomized patients will have core laboratory studies repeated at specified follow-up intervals. Nuclear cardiology testing in STICH will prospectively test the hypothesis that imaging to assess myocardial ischemia and/or viability in patients with CAD and HF identifies a subset of patients in whom MED + CABG provides a survival benefit over MED and another subset in whom CABG provides no such benefit. In addition, in patients in the trial who do not undergo cardiac magnetic resonance imaging, gated perfusion imaging will be performed to measure LV EF and ESVI and will serve to determine which of these patients are candidates for SVR. The LV volume and function data in these patients will also be used to test the hypothesis that LV ESVI at baseline, and changes in ESVI after medical or surgical therapy (with and without SVR) at 4 months, are important predictors of subsequent survival. The myocardial perfusion images in STICH will be submitted to the nuclear cardiology core coordinating center at Northwestern University, which will serve as the core laboratory for qualitative interpretation of the images. The nuclear core coordinating center will also be responsible for transmission of images to the LV function core laboratory at Cedars- Sinai Medical Center, transmission of the images to the quantitative perfusion core laboratory at the University of Virginia, and transmission of data to the STICH Coordinating Center.
