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

Eric J. Velazquez, Kerry L. Lee, Christopher M. O'Connor, Jae Kuen Oh, Robert O. Bonow, Gerald M. Pohost, Arthur M. Feldman, Daniel B. Mark, Julio A. Panza, George Sopko, Jean L. Rouleau, Robert H. Jones

Research output: Contribution to journalArticle

142 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalJournal of Thoracic and Cardiovascular Surgery
Volume134
Issue number6
DOIs
StatePublished - Dec 2007

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Heart Failure
Coronary Artery Bypass
Therapeutics
Survival
National Heart, Lung, and Blood Institute (U.S.)
Left Ventricular Dysfunction
Random Allocation
Cardiomyopathies
Stroke Volume
Cost-Benefit Analysis
Coronary Artery Disease
Hospitalization
Biomarkers
Quality of Life

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

Cite this

The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. / Velazquez, Eric J.; Lee, Kerry L.; O'Connor, Christopher M.; Oh, Jae Kuen; Bonow, Robert O.; Pohost, Gerald M.; Feldman, Arthur M.; Mark, Daniel B.; Panza, Julio A.; Sopko, George; Rouleau, Jean L.; Jones, Robert H.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 134, No. 6, 12.2007.

Research output: Contribution to journalArticle

Velazquez, EJ, Lee, KL, O'Connor, CM, Oh, JK, Bonow, RO, Pohost, GM, Feldman, AM, Mark, DB, Panza, JA, Sopko, G, Rouleau, JL & Jones, RH 2007, 'The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial', Journal of Thoracic and Cardiovascular Surgery, vol. 134, no. 6. https://doi.org/10.1016/j.jtcvs.2007.05.069
Velazquez, Eric J. ; Lee, Kerry L. ; O'Connor, Christopher M. ; Oh, Jae Kuen ; Bonow, Robert O. ; Pohost, Gerald M. ; Feldman, Arthur M. ; Mark, Daniel B. ; Panza, Julio A. ; Sopko, George ; Rouleau, Jean L. ; Jones, Robert H. / The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. In: Journal of Thoracic and Cardiovascular Surgery. 2007 ; Vol. 134, No. 6.
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AU - Bonow, Robert O.

AU - Pohost, Gerald M.

AU - Feldman, Arthur M.

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