Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/21/2016 |
| Start Date: | January 2002 |
| End Date: | April 2016 |
Surgical Treatment for Ischemic Heart Failure (STICH)
This study will compare medical therapy with coronary bypass surgery and/or surgical
ventricular restoration for patients with congestive heart failure and coronary artery
disease (CAD).
ventricular restoration for patients with congestive heart failure and coronary artery
disease (CAD).
BACKGROUND:
Congestive heart failure afflicts approximately five million Americans and is the leading
cause of hospitalization in Americans over the age of 65. Most cases of congestive heart
failure are due to CAD. Surprisingly little is known about the relative benefits of medical
versus surgical therapy for patients with obstructive coronary disease and congestive heart
failure. Randomized studies of medical therapy versus bypass surgery for obstructive
coronary disease were conducted in the 1970s and did not include the systematic use of
aspirin, arterial conduits, or lipid-lowering medications. In addition, patients with
ejection fractions below 35% were specifically excluded from the three large randomized
studies of medical therapy versus bypass surgery. While observational data from the 1970s
and early 1980s suggest a survival advantage associated with bypass surgery in patients with
low ejection fraction and congestive heart failure, biases favoring the referral of the
fittest of such patients for bypass surgery may have confounded these comparisons. In
addition, medical therapy for congestive heart failure has improved dramatically over the
past two decades. Thus, the choice of medical therapy versus bypass surgery for patients
with congestive heart failure and obstructive coronary disease is usually decided by
guesswork. This study is designed to provide a solid answer.
PURPOSE:
STICH is a multicenter, international, randomized trial that addresses two specific primary
hypotheses in patients with clinical heart failure (HF) and left ventricular (LV)
dysfunction who have coronary artery disease amenable to surgical revascularization. The
first hypothesis is that restoration of blood flow by means of coronary revascularization
recovers chronic LV dysfunction and improves survival, as compared to intensive medical
therapy alone. The second hypothesis is that surgical ventricular restoration (SVR) to a
more normal LV size improves survival free of subsequent hospitalization for cardiac cause
compared to CABG alone. Patients eligible for either medical therapy or CABG, but not
eligible for the SVR procedure (Stratum A), will be randomized in equal proportions to
medical therapy alone versus CABG plus medical therapy. Patients eligible for all three
therapies (Stratum B) will be randomized in equal proportions to medical therapy alone, CABG
plus medical therapy, and CABG plus SVR plus medical therapy. Patients whose severity of
angina or CAD makes them inappropriate for medical therapy alone (Stratum C) will be
randomized in equal proportions to CABG plus medical therapy versus CABG plus SVR plus
medical therapy. The overall target is to recruit 1200 patients into Hypothesis One and
1,000 patients into Hypothesis Two. Secondary endpoints include the role of myocardial
viability, morbidity, economics, and quality of life. Core laboratories for quality of
life/economics, cardiac magnetic resonance (CMR), echocardiography (ECHO),
neurohormonal/cytokine/genetic (NCG), and radionuclide (RN) studies ensure consistent
testing practices and standardization of data necessary to identify eligible patients and to
address specific questions related to the stated hypotheses.
IMPORTANCE OF RESEARCH:
The most common cause of HF is no longer hypertension or valvular heart disease as it was in
previous decades, but rather CAD. HF is a common worldwide disease and CAD is a frequent
cause of HF initiation and progression. HF is responsible for approximately 1 million
hospitalizations and 300,000 fatalities annually. The prevalence of HF is increasing,
largely due to enhanced survival following acute myocardial infarction and other
manifestations of CAD. No randomized trial has ever compared directly the long-term benefits
of surgical, medical, or combined surgical and medical treatment of patients with ischemic
HF. The STICH trial is the first trial to compare the long term benefits of surgical and
medical treatment in patients with ischemic HF. Although modern medical therapy for HF
modestly improves quality of life, a more aggressive approach with the surgical therapies
being studied in the STICH trial may produce even greater improvements. The common clinical
practice of not offering CABG to patients with LV dysfunction in regions found to be
nonviable on noninvasive studies is not evidence-based. Since only those patients for whom
intensive medical therapy is the only reasonable therapeutic alternative are excluded from
this study, the results of the STICH trial should be applicable to most patients with CAD,
HF, and systolic LV dysfunction. The results of the STICH trial will also establish whether
measurements of neurohormonal and cytokine levels and genetic profiling are useful for
directing patient management decisions, for monitoring the effectiveness of therapy, and for
refining the optimal approach for selecting the treatment strategy most likely to be
effective for the many of these patients.
ACCOMPLISHMENTS AND OTHER ISSUES:
The study is currently in an extended follow-up mode for patients enrolled in Hypothesis 1
(H01). The last patient follow-up is anticipated in late fall of 2015. Patient recruitment
into Hypothesis 2 (H02) was completed in January 2006, with 1,000 patients enrolled
worldwide. All recruitment ended on May 4, 2007, with total of 2,212 patients enrolled, and
1,212 patients enrolled into Hypothesis One (H01). To date, the study has already recruited
more patients (815) than the number of patients enrolled in a landmark clinical trial of
bypass surgery known as the Coronary Artery Surgery Study (CASS). The CASS trial, conducted
almost 30 years ago, was the largest trial of bypass surgery until the current STICH trial.
Congestive heart failure afflicts approximately five million Americans and is the leading
cause of hospitalization in Americans over the age of 65. Most cases of congestive heart
failure are due to CAD. Surprisingly little is known about the relative benefits of medical
versus surgical therapy for patients with obstructive coronary disease and congestive heart
failure. Randomized studies of medical therapy versus bypass surgery for obstructive
coronary disease were conducted in the 1970s and did not include the systematic use of
aspirin, arterial conduits, or lipid-lowering medications. In addition, patients with
ejection fractions below 35% were specifically excluded from the three large randomized
studies of medical therapy versus bypass surgery. While observational data from the 1970s
and early 1980s suggest a survival advantage associated with bypass surgery in patients with
low ejection fraction and congestive heart failure, biases favoring the referral of the
fittest of such patients for bypass surgery may have confounded these comparisons. In
addition, medical therapy for congestive heart failure has improved dramatically over the
past two decades. Thus, the choice of medical therapy versus bypass surgery for patients
with congestive heart failure and obstructive coronary disease is usually decided by
guesswork. This study is designed to provide a solid answer.
PURPOSE:
STICH is a multicenter, international, randomized trial that addresses two specific primary
hypotheses in patients with clinical heart failure (HF) and left ventricular (LV)
dysfunction who have coronary artery disease amenable to surgical revascularization. The
first hypothesis is that restoration of blood flow by means of coronary revascularization
recovers chronic LV dysfunction and improves survival, as compared to intensive medical
therapy alone. The second hypothesis is that surgical ventricular restoration (SVR) to a
more normal LV size improves survival free of subsequent hospitalization for cardiac cause
compared to CABG alone. Patients eligible for either medical therapy or CABG, but not
eligible for the SVR procedure (Stratum A), will be randomized in equal proportions to
medical therapy alone versus CABG plus medical therapy. Patients eligible for all three
therapies (Stratum B) will be randomized in equal proportions to medical therapy alone, CABG
plus medical therapy, and CABG plus SVR plus medical therapy. Patients whose severity of
angina or CAD makes them inappropriate for medical therapy alone (Stratum C) will be
randomized in equal proportions to CABG plus medical therapy versus CABG plus SVR plus
medical therapy. The overall target is to recruit 1200 patients into Hypothesis One and
1,000 patients into Hypothesis Two. Secondary endpoints include the role of myocardial
viability, morbidity, economics, and quality of life. Core laboratories for quality of
life/economics, cardiac magnetic resonance (CMR), echocardiography (ECHO),
neurohormonal/cytokine/genetic (NCG), and radionuclide (RN) studies ensure consistent
testing practices and standardization of data necessary to identify eligible patients and to
address specific questions related to the stated hypotheses.
IMPORTANCE OF RESEARCH:
The most common cause of HF is no longer hypertension or valvular heart disease as it was in
previous decades, but rather CAD. HF is a common worldwide disease and CAD is a frequent
cause of HF initiation and progression. HF is responsible for approximately 1 million
hospitalizations and 300,000 fatalities annually. The prevalence of HF is increasing,
largely due to enhanced survival following acute myocardial infarction and other
manifestations of CAD. No randomized trial has ever compared directly the long-term benefits
of surgical, medical, or combined surgical and medical treatment of patients with ischemic
HF. The STICH trial is the first trial to compare the long term benefits of surgical and
medical treatment in patients with ischemic HF. Although modern medical therapy for HF
modestly improves quality of life, a more aggressive approach with the surgical therapies
being studied in the STICH trial may produce even greater improvements. The common clinical
practice of not offering CABG to patients with LV dysfunction in regions found to be
nonviable on noninvasive studies is not evidence-based. Since only those patients for whom
intensive medical therapy is the only reasonable therapeutic alternative are excluded from
this study, the results of the STICH trial should be applicable to most patients with CAD,
HF, and systolic LV dysfunction. The results of the STICH trial will also establish whether
measurements of neurohormonal and cytokine levels and genetic profiling are useful for
directing patient management decisions, for monitoring the effectiveness of therapy, and for
refining the optimal approach for selecting the treatment strategy most likely to be
effective for the many of these patients.
ACCOMPLISHMENTS AND OTHER ISSUES:
The study is currently in an extended follow-up mode for patients enrolled in Hypothesis 1
(H01). The last patient follow-up is anticipated in late fall of 2015. Patient recruitment
into Hypothesis 2 (H02) was completed in January 2006, with 1,000 patients enrolled
worldwide. All recruitment ended on May 4, 2007, with total of 2,212 patients enrolled, and
1,212 patients enrolled into Hypothesis One (H01). To date, the study has already recruited
more patients (815) than the number of patients enrolled in a landmark clinical trial of
bypass surgery known as the Coronary Artery Surgery Study (CASS). The CASS trial, conducted
almost 30 years ago, was the largest trial of bypass surgery until the current STICH trial.
Inclusion Criteria:
- Symptomatic heart failure defined as New York Heart Association (NYHA) Class II-IV
(within 3 months of entry)
- LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated
single photon emission computed tomography (SPECT) studies
- Coronary anatomy suitable for revascularization
Exclusion Criteria:
- Clearly defined primary valvular heart disease indicating the need for valve repair
or replacement
- Concurrent cardiogenic shock, or requiring inotropic or intra-aortic balloon support
- Percutaneous coronary intervention (PCI) planned for CAD treatment
- Acute myocardial infarction within 30 days of study entry
- More than one prior cardiac operation
- Non-cardiac illness with life expectancy less than 3 years
- Non-cardiac illness imposing substantial operative mortality
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