Current Research & Innovations Cardiac

STICH Trial: Optimizing Management of Complex Heart Disease Patients

Physician-scientists at NewYork-Presbyterian Hospital/Columbia University Medical Center (NewYork-Presbyterian/Columbia) are participating in a new and exciting clinical research effort through the collaborative efforts of the Departments of Surgery and Medicine. The Surgical Treatment of Ischemic Heart Failure (STICH) Trial is a multi-national, randomized National Institutes of Health (NIH) funded project to test treatment alternatives for patients with left ventricular dysfunction and coronary artery disease that is amenable to surgical revascularization (bypass surgery). Deborah Ascheim, MD, Assistant Professor of Medicine (and Public Health) at Columbia University College of Physicians & Surgeons, is the principal investigator of the trial at Columbia.

The STICH trial will address two primary questions concerning the surgical therapeutic options in these complex patients:

Will coronary artery bypass grafting (CABG) surgery combined with intensive medical therapy improve long-term survival compared to medical therapy alone?
In patients with left ventricular akinesia (lack of movement) and dilatation, will left ventricular shape and size optimization by surgical ventricular restoration (SVR) combined with CABG and medical therapy improve long-term survival free of cardiac hospitalization compared to CABG and medical therapy without SVR?

Over the next three years, 50 centers will recruit 2,800 patients for the randomized trial. It is estimated that an additional 3,400 patients will enroll in the STICH trial registry, the non-randomized, follow-up-only alternative to the trial. Secondary endpoints to be addressed in the study include cardiac mortality and morbidity, health resource utilization, cost effectiveness, quality of life, and exercise capacity. Follow-up data collection for all trial participants will continue for three to six years.

Researchers at NewYork-Presbyterian/Columbia are hopeful that by addressing the role of CABG and SVR in the growing population of patients with ischemic cardiomyopathy, the STICH trial will positively impact clinical practice in the same manner as previous landmark cardiothoracic surgery trials.

STICH Trial Inclusion Criteria:

NYHA Class I–IV
LVEF < 35%
Coronary anatomy suitable for revascularization
Age > 18 and competent to give informed consent

STICH Trial Exclusion Criteria:

Primary valvular disease clearly defined with the need for valve repair/replacement
Cardiogenic shock (within 72 hours of randomization) requiring inotropic or intra-aortic balloon support
Percutaneous coronary intervention planned for coronary artery disease treatment
Acute myocardial infarction within 30 days
More than one prior cardiac operation
Non-cardiac illness with life expectancy < 3 years or imposing substantial operative mortality
Refractory potentially lethal ventricular arrythmias
Previous major organ transplantation
Other conditions likely to lead to poor treatment adherence (non-compliance)
Current participation in any other clinical trial in which the subject is taking an investigational drug or receiving an investigational device

For more information on the STICH clinical trial (IRB# 5625), please contact Dr. Ascheim at 212.305.9264.