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The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial
Eric J Velazquez1, Kerry L Lee, Christopher M O'Connor
1Division of Cardiovascular Medicine, Department of Medicine, Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC, USA.
Insights
The Surgical Treatment for Ischemic Heart Failure (STICH) trial investigated if coronary artery bypass grafting improves survival in patients with ischemic cardiomyopathy. Results are pending, but the trial design addresses contemporary treatment effectiveness.
Area of Science:
- Cardiology
- Cardiovascular Surgery
- Clinical Trials
Background:
- Ischemic cardiomyopathy affects numerous patients, with limited prior randomized data comparing medical therapy to coronary artery bypass grafting (CABG).
- Previous studies on CABG for ischemic heart failure were conducted over two decades ago, necessitating updated research on contemporary practices.
Purpose of the Study:
- To evaluate the efficacy of CABG combined with medical therapy versus medical therapy alone in improving survival for patients with ischemic heart failure.
- To assess the benefit of surgical ventricular reconstruction (SVR) in addition to CABG for patients with anterior left ventricular dysfunction.
Main Methods:
- The STICH trial is a multicenter international randomized trial enrolling patients with heart failure and ejection fraction ≤0.35.
- Patients were randomized into three groups: medical therapy alone, medical therapy plus CABG, or medical therapy plus CABG and SVR, based on physician judgment of eligibility.
- Substudies examine quality of life, cost-effectiveness, ventricular volumes, myocardial viability, biomarkers, and polymorphisms.
Main Results:
- Enrollment for both STICH hypotheses is complete.
- Follow-up is ongoing to gather sufficient data for primary outcome analysis.
- Primary outcomes for hypothesis 2 are expected in 2009, and for hypothesis 1 in 2011.
Conclusions:
- The STICH trial aims to determine if CABG with intensive medical therapy enhances long-term survival compared to medical therapy alone.
- It also investigates whether adding SVR to CABG improves event-free survival in patients with anterior left ventricular dysfunction.
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.