TY - JOUR
T1 - The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial
AU - Velazquez, Eric J.
AU - Lee, Kerry L.
AU - O'Connor, Christopher M.
AU - Oh, Jae K.
AU - Bonow, Robert O.
AU - Pohost, Gerald M.
AU - Feldman, Arthur M.
AU - Mark, Daniel B.
AU - Panza, Julio A.
AU - Sopko, George
AU - Rouleau, Jean L.
AU - Jones, Robert H.
N1 - Funding Information:
The STICH trial is an investigator-initiated, international study funded by the NHLBI of the National Institutes of Health. The STICH Steering Committee is comprised of principal investigators at all enrolling sites. An executive council is empowered by the Steering Committee to make day-to-day decisions ( Appendix E1 ). However, all major executive council decisions are subject to review and approval of the Steering Committee.
PY - 2007/12
Y1 - 2007/12
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=36048937641&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=36048937641&partnerID=8YFLogxK
U2 - 10.1016/j.jtcvs.2007.05.069
DO - 10.1016/j.jtcvs.2007.05.069
M3 - Article
C2 - 18023680
AN - SCOPUS:36048937641
SN - 0022-5223
VL - 134
SP - 1540-1547.e4
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 6
ER -