Clinical trial NCT00023595: Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
Official title: Surgical Treatment for Ischemic Heart Failure (STICH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Failure, Congestive
Heart Diseases
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2001-09-11
Enrollment: 2136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease (CAD).

Detailed description: 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 was 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.

Eligibility criteria: Inclusion Criteria:

* 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:

* Failure to provide informed consent.
* Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement.
* Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.
* Plan for percutaneous intervention of CAD.
* Recent acute MI judged to be an important cause of left ventricular dysfunction.
* History of more than 1 prior coronary bypass operation.
* Noncardiac illness with a life expectancy of less than 3 years.
* Noncardiac illness imposing substantial operative mortality.
* Conditions/circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
* Previous heart, kidney, liver, or lung transplantation.
* Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.

MED Therapy Eligibility Criteria

* Absence of left main CAD as defined by an intraluminal stenosis of 50% or greater.
* Absence of CCS III angina or greater (angina markedly limiting ordinary activity).

SVR Eligibility Criterion

• Dominant akinesia or dyskinesia of the anterior left ventricular wall amenable to SVR.

Primary outcomes:
measure: H01: All Cause Mortality
timeFrame: 5 years post randomization
measure: H01: All Cause Mortality
timeFrame: 10 years post randomization
measure: H02: All-cause Mortality or Cardiovascular Hospitalization
timeFrame: 5 years post randomization
Secondary outcomes:
measure: H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
timeFrame: 10 years post randomization
measure: H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
timeFrame: 5 years post randomization
measure: H01: Mortality or Cardiovascular Hospitalization
timeFrame: up to 5 years post randomization
measure: H01: Mortality or Cardiovascular Hospitalization
timeFrame: up to 10 years post randomization
measure: H02: All-cause Mortality
timeFrame: up to 5 years
measure: H01: All-cause Mortality Within 30 Days After Randomization
timeFrame: 30 days post randomization
measure: H02: All-cause Mortality Within 30 Days After Randomization
timeFrame: 30 days post randomization
measure: H01: All-cause Mortality or Heart-failure Hospitalization
timeFrame: 5 years post randomization
measure: H02: All-cause Mortality or Heart-failure Hospitalization
timeFrame: 5 years post randomization
measure: H01: All-cause Mortality or Heart-failure Hospitalization
timeFrame: 10 years post randomization
measure: H01: Heart Failure Hospitalization
timeFrame: 5 years post randomization
measure: H02: Heart Failure Hospitalization
timeFrame: 5 years post randomization
measure: H01: Heart Failure Hospitalization
timeFrame: 10 years post randomization
measure: H01: Cardiac Procedure: Heart Transplant
timeFrame: 5 years post randomization
measure: H02: Cardiac Procedure: Heart Transplant
timeFrame: 5 years post randomization
measure: H01: Cardiac Procedure: Heart Transplant
timeFrame: 10 years post randomization
measure: H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
timeFrame: 5 years post randomization
measure: H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
timeFrame: 5 years post randomization
measure: H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
timeFrame: 10 years post randomization
measure: H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
timeFrame: 5 years post randomization
measure: H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
timeFrame: 5 years post randomization
measure: H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
timeFrame: 10 years post randomization
measure: H01: Stroke
timeFrame: 5 years post randomization
measure: H01: Stroke
timeFrame: 10 years post randomization
measure: H02: Stroke
timeFrame: 5 years post randomization
measure: H01: All-cause Mortality or Revascularization (CABG or PCI)
timeFrame: 5 years post randomization
measure: H02: All-cause Mortality or Revascularization (CABG or PCI)
timeFrame: 5 years post randomization
measure: H01: All-cause Mortality or Revascularization (CABG or PCI)
timeFrame: 10 years post randomization
measure: H01: All-cause Mortality, Heart Transplant or LVAD
timeFrame: 5 years post randomization
measure: H02: All-cause Mortality, Heart Transplant or LVAD
timeFrame: 5 years post randomization
measure: H01: All-cause Mortality, Heart Transplant or LVAD
timeFrame: 10 years post randomization
measure: H01: All-cause (Unplanned and Elective) Hospitalization
timeFrame: 5 years post randomization
measure: H02: All-cause (Unplanned and Elective) Hospitalization
timeFrame: 5 years post randomization
measure: H01: All-cause (Unplanned and Elective) Hospitalization
timeFrame: 10 years post randomization
measure: H01: 6 Minute Walk Distance
timeFrame: From randomization to 24 month follow-up
measure: H02: 6 Minute Walk Distance
timeFrame: From randomization to 24 month follow-up
measure: H01: Exercise Duration
timeFrame: From randomization to 24 months follow-up
measure: H02: Exercise Duration
timeFrame: From randomization to 24 months follow-up
measure: H01: LVEF by ECHO Core Lab During Follow-up
timeFrame: From randomization to 24 months follow-up
measure: H02: LVEF by ECHO Core Lab During Follow-up
timeFrame: From randomization to 24 months follow-up
measure: H01: LVEF by RN Core Lab During Follow-up
timeFrame: From randomization to 24 months follow-up
measure: H02: LVEF by RN Core Lab During Follow-up
timeFrame: From randomization to 24 months follow-up
measure: H01: LVEF by CMR Core Lab During Follow-up
timeFrame: From randomization to 24 months follow-up
measure: H02: LVEF by CMR Core Lab During Follow-up
timeFrame: From randomization to 24 months follow-up
measure: H01: B-type Natriuretic Peptide (BNP)
timeFrame: From randomization to 24 months follow-up
measure: H02: B-type Natriuretic Peptide (BNP)
timeFrame: From randomization to 24 months follow-up
measure: H01: SF-36 Mental Health Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H02: SF-36 Mental Health Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H01:SF-36 Role Physical Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H02: SF-36 Role Physical Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H01:SF-36 Role Emotional Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H02: SF-36 Role Emotional Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H01:SF-36 Social Functioning Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H02: SF-36 Social Functioning Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H01:SF-36 Vitality Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H02: SF-36 Vitality Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H01:SF-12 Physical Component Summary (PCS) Scale
timeFrame: From enrollment to 3-year follow-up
measure: H02: SF-12 Physical Component Summary (PCS) Scale
timeFrame: From enrollment to 3-year follow-up
measure: H01: SF-12 Mental Component Summary (MCS) Scale
timeFrame: From enrollment to 3-year follow-up
measure: H02: SF-12 Mental Component Summary (MCS) Scale
timeFrame: From enrollment to 3-year follow-up
measure: H01: KCCQ Physical Limitation Scale
timeFrame: From enrollment to 3-year follow-up
measure: H02: KCCQ Physical Limitation Scale
timeFrame: From enrollment to 3-year follow-up
measure: H01: KCCQ Symptom Stability
timeFrame: From enrollment to 3-year follow-up
measure: H02: KCCQ Symptom Stability
timeFrame: From enrollment to 3-year follow-up
measure: H01: KCCQ Symptom Frequency
timeFrame: From enrollment to 3-year follow-up
measure: H02: KCCQ Symptom Frequency
timeFrame: From enrollment to 3-year follow-up
measure: H01: KCCQ Symptom Burden
timeFrame: From enrollment to 3-year follow-up
measure: H02: KCCQ Symptom Burden
timeFrame: From enrollment to 3-year follow-up
measure: H01: KCCQ Total Symptoms
timeFrame: From enrollment to 3-year follow-up
measure: H02: KCCQ Total Symptoms
timeFrame: From enrollment to 3-year follow-up
measure: H01: KCCQ Quality-of-Life Scale
timeFrame: From enrollment to 3-year follow-up
measure: H02: KCCQ Quality-of-Life Scale
timeFrame: From enrollment to 3-year follow-up
measure: H01: KCCQ Social Limitation
timeFrame: From enrollment to 3-year follow-up
measure: H02: KCCQ Social Limitation
timeFrame: From enrollment to 3-year follow-up
measure: H01: KCCQ Clinical Summary Score
timeFrame: From enrollment to 3-year follow-up
measure: H02: KCCQ Clinical Summary Score
timeFrame: From enrollment to 3-year follow-up
measure: H01: KCCQ Overall Summary Score
timeFrame: From enrollment to 3-year follow-up
measure: H02: KCCQ Overall Summary Score
timeFrame: From enrollment to 3-year follow-up
measure: H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H01: EQ-5D Visual Analog Scale
timeFrame: From enrollment to 3-year follow-up
measure: H02: EQ-5D Visual Analog Scale
timeFrame: From enrollment to 3-year follow-up
measure: H01: EQ-5D Health Status Index Score
timeFrame: From enrollment to 3-year follow-up
measure: H02: EQ-5D Health Status Index Score
timeFrame: From enrollment to 3-year follow-up
measure: H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
timeFrame: From enrollment to 3-year follow-up
measure: H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
timeFrame: From enrollment to 3-year follow-up
measure: H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
timeFrame: From enrollment to 3-year follow-up
measure: H01: General Health Rating Scale
timeFrame: From enrollment to 3-year follow-up
measure: H02: General Health Rating Scale
timeFrame: From enrollment to 3-year follow-up
measure: H01: Cost of Care
timeFrame: index hospital admission
measure: H02: Cost of Care
timeFrame: index hospital admission
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Radionuclide Core Lab, Northwestern University
name: Robert Bonow
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurohormonal Core Lab, Jefferson University
name: Arthur Feldman
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Coordinating Center, Duke University
name: Eric Velazquez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Data Coordinating Center, Duke University
name: Kerry Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Economics and Quality of Life Core Lab, Duke University
name: Daniel Mark
role: PRINCIPAL_INVESTIGATOR
affiliation: Echocardiographic Core Lab, Mayo Clinic
name: Jae Oh
role: PRINCIPAL_INVESTIGATOR
affiliation: Magnetic Resonance Imaging Core Lab, University of Southern California
name: Gerald Pohost
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Jean Rouleau
role: STUDY_CHAIR
affiliation: Medstar Health Research Institute
name: Julio A Panza, MD
role: PRINCIPAL_INVESTIGATOR
References:
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