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J Thorac Cardiovasc Surg 2007;134:1540-1547
© 2007 The American Association for Thoracic Surgery

Surgery for Acquired Cardiovascular Disease

The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial

^a Division of Cardiovascular Medicine, Department of Medicine, Duke University Medical Center, Durham, NC
^b Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC
^c Duke Clinical Research Institute, Durham, NC
^d Division of Cardiology, Mayo Clinic, Rochester, Minn
^e Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill
^f Division of Cardiovascular Medicine, Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, Calif
^g Division of Cardiology, Department of Medicine, Jefferson Medical College, Philadelphia, Pa
^h Division of Cardiology, Washington Hospital Center, Washington, DC
ⁱ National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md
^j Department of Medicine, University of Montreal, Montreal, Canada
^k Division of Cardiothoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC.

Received for publication March 28, 2007; accepted for publication May 11, 2007.

^_* Address for reprints: Eric J. Velazquez, MD, Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC 27715. (Email: eric.velazquez{at}duke.edu).

Objectives: The rationale and design of the Surgical Treatment for Ischemic Heart Failure trial is described. Before the Surgical Treatment for Ischemic Heart Failure trial, less than 1000 patients with ischemic cardiomyopathy had been studied in randomized comparisons of medical therapy versus coronary artery bypass grafting. Trial data reflect how these therapies were delivered more than 20 years ago and do not indicate the relative benefits of medical therapy versus coronary artery bypass grafting in contemporary practice.

Methods: Randomization of consenting patients with heart failure, left ventricular ejection fraction of 0.35 or less, and coronary artery disease is based on whether patients are judged by attending physicians to be candidates only for coronary artery bypass grafting or can be treated with medical therapy without coronary artery bypass grafting. Patients eligible for surgical ventricular reconstruction because of significant anterior wall akinesis or dyskinesis but ineligible for medical therapy are randomly assigned to coronary artery bypass grafting with or without surgical ventricular reconstruction. Patients eligible for medical therapy are randomly assigned between medical therapy only and medical therapy with coronary artery bypass grafting. Patients eligible for all 3 are randomly assigned evenly to medical therapy only, medical therapy and coronary artery bypass grafting, or medical therapy and coronary artery bypass grafting and surgical ventricular reconstruction. Major substudies will examine quality of life, cost-effectiveness, changes in left ventricular volumes, effect of myocardial viability, selected biomarkers, and selected polymorphisms on treatment differences.

Results: Enrollment is now complete in both STICH hypotheses. Follow-up will continue until sufficient end points are available to address both hypotheses with at least 90% power. The primary outcome of hypothesis 2 is expected to be reported in 2009. The primary outcome of hypothesis 1 is expected to be reported in 2011.

Conclusions: The Surgical Treatment for Ischemic Heart Failure trial is a National Heart, Lung, and Blood Institute–funded multicenter international randomized trial addressing 2 specific primary hypotheses: (1) coronary artery bypass grafting with intensive medical therapy improves long-term survival compared with survival with medical therapy alone, and (2) in patients with anterior left ventricular dysfunction, surgical ventricular reconstruction to a more normal left ventricular size plus coronary artery bypass grafting improves survival free of subsequent hospitalization for cardiac cause when compared with that with coronary artery bypass grafting alone.

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