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 ensure 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 clinical 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. In the patients randomized to MED with or without CABG, CABG with MED is hypothesized to demonstrate a >20% reduction in the primary endpoint of all-cause death with an 89% power from the projected 25% three-year mortality for MED. In the SVR-eligible patients, CABG + SVR is hypothesized to show a 20% advantage with 90% power in the endpoint of survival free of hospitalization for cardiac cause projected to be 50% at three years in patients receiving CABG without SVR. Definition of efficacy of potential therapies and their mechanisms of benefit by the STICH Trial is certain to inform future choice of therapy and thereby extend and improve the quality of lives of millions of patients who now suffer from ischemic HF.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HL069011-01
Application #
6429930
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Sopko, George
Project Start
2002-01-01
Project End
2008-12-31
Budget Start
2002-01-01
Budget End
2002-12-31
Support Year
1
Fiscal Year
2002
Total Cost
$321,141
Indirect Cost
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705
Feldman, Arthur M; She, Lilin; McNamara, Dennis M et al. (2015) Genetic variants are not associated with outcome in patients with coronary artery disease and left ventricular dysfunction: results of the Genetic Substudy of the Surgical Treatment for Ischemic Heart Failure (STICH) trials. Cardiology 130:69-81
Bonow, Robert O; Castelvecchio, Serenella; Panza, Julio A et al. (2015) Severity of Remodeling, Myocardial Viability, and Survival in Ischemic LV Dysfunction After Surgical Revascularization. JACC Cardiovasc Imaging 8:1121-9
Mark, Daniel B; Knight, J David; Velazquez, Eric J et al. (2014) Quality-of-life outcomes with coronary artery bypass graft surgery in ischemic left ventricular dysfunction: a randomized trial. Ann Intern Med 161:392-9
Feldman, Arthur M; Mann, Douglas L; She, Lilin et al. (2013) Prognostic significance of biomarkers in predicting outcome in patients with coronary artery disease and left ventricular dysfunction: results of the biomarker substudy of the Surgical Treatment for Ischemic Heart Failure trials. Circ Heart Fail 6:461-72
Bonow, Robert O; Maurer, Gerald; Lee, Kerry L et al. (2011) Myocardial viability and survival in ischemic left ventricular dysfunction. N Engl J Med 364:1617-25
Mark, Daniel B; Knight, J David; Velazquez, Eric J et al. (2009) Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial. Am Heart J 157:837-44, 844.e1-3