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Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease (STICH)

Primary Purpose

Cardiovascular Diseases, Coronary Disease, Heart Failure, Congestive

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CABG surgery plus MED
Active Medication Alone
CABG plus MED and SVR
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

H01: Medication

H01: Medication + CABG

H02: Medication+CABG

H02: Medication+CABG+SVR

Arm Description

Medical therapy alone to treat Coronary Artery Disease

Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease

Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease

CABG plus Medication and Surgical ventricular reconstruction (SVR)

Outcomes

Primary Outcome Measures

H01: All Cause Mortality
H01: All Cause Mortality
H02: All-cause Mortality or Cardiovascular Hospitalization

Secondary Outcome Measures

H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
H01: Mortality or Cardiovascular Hospitalization
H01: Mortality or Cardiovascular Hospitalization
H02: All-cause Mortality
H01: All-cause Mortality Within 30 Days After Randomization
H02: All-cause Mortality Within 30 Days After Randomization
H01: All-cause Mortality or Heart-failure Hospitalization
H02: All-cause Mortality or Heart-failure Hospitalization
H01: All-cause Mortality or Heart-failure Hospitalization
H01: Heart Failure Hospitalization
H02: Heart Failure Hospitalization
H01: Heart Failure Hospitalization
H01: Cardiac Procedure: Heart Transplant
H02: Cardiac Procedure: Heart Transplant
H01: Cardiac Procedure: Heart Transplant
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
H01: Stroke
H01: Stroke
H02: Stroke
H01: All-cause Mortality or Revascularization (CABG or PCI)
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
H02: All-cause Mortality or Revascularization (CABG or PCI)
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
H01: All-cause Mortality or Revascularization (CABG or PCI)
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
H01: All-cause Mortality, Heart Transplant or LVAD
LVAD=Left Ventricular Assist Device
H02: All-cause Mortality, Heart Transplant or LVAD
H01: All-cause Mortality, Heart Transplant or LVAD
LVAD=Left Ventricular Assist Device
H01: All-cause (Unplanned and Elective) Hospitalization
H02: All-cause (Unplanned and Elective) Hospitalization
H01: All-cause (Unplanned and Elective) Hospitalization
H01: 6 Minute Walk Distance
H02: 6 Minute Walk Distance
H01: Exercise Duration
Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
H02: Exercise Duration
Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
H01: LVEF by ECHO Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
H02: LVEF by ECHO Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
H01: LVEF by RN Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
H02: LVEF by RN Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
H01: LVEF by CMR Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
H02: LVEF by CMR Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
H01: B-type Natriuretic Peptide (BNP)
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
H02: B-type Natriuretic Peptide (BNP)
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
H01: SF-36 Mental Health Subscale
Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
H02: SF-36 Mental Health Subscale
These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
H01:SF-36 Role Physical Subscale
These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
H02: SF-36 Role Physical Subscale
These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
H01:SF-36 Role Emotional Subscale
These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
H02: SF-36 Role Emotional Subscale
These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
H01:SF-36 Social Functioning Subscale
These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
H02: SF-36 Social Functioning Subscale
These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
H01:SF-36 Vitality Subscale
These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
H02: SF-36 Vitality Subscale
These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
H01:SF-12 Physical Component Summary (PCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
H02: SF-12 Physical Component Summary (PCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
H01: SF-12 Mental Component Summary (MCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
H02: SF-12 Mental Component Summary (MCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
H01: KCCQ Physical Limitation Scale
Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
H02: KCCQ Physical Limitation Scale
These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
H01: KCCQ Symptom Stability
This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome. .
H02: KCCQ Symptom Stability
This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.
H01: KCCQ Symptom Frequency
These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
H02: KCCQ Symptom Frequency
These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
H01: KCCQ Symptom Burden
These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
H02: KCCQ Symptom Burden
These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
H01: KCCQ Total Symptoms
This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
H02: KCCQ Total Symptoms
This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
H01: KCCQ Quality-of-Life Scale
These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
H02: KCCQ Quality-of-Life Scale
These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
H01: KCCQ Social Limitation
These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
H02: KCCQ Social Limitation
These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
H01: KCCQ Clinical Summary Score
This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
H02: KCCQ Clinical Summary Score
This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
H01: KCCQ Overall Summary Score
This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
H02: KCCQ Overall Summary Score
This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina. .
H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.
H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina. .
H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.
H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes. .
H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.
H01: EQ-5D Visual Analog Scale
Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health. .
H02: EQ-5D Visual Analog Scale
This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.
H01: EQ-5D Health Status Index Score
This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale. .
H02: EQ-5D Health Status Index Score
This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.)
H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high. .
H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.
H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. .
H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. .
H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
H01: General Health Rating Scale
This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health. .
H02: General Health Rating Scale
This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.
H01: Cost of Care
Hospital costs and physician fees for US patients
H02: Cost of Care
Hospital costs and physician fees for US patients

Full Information

First Posted
September 11, 2001
Last Updated
September 17, 2019
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00023595
Brief Title
Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
Acronym
STICH
Official Title
Surgical Treatment for Ischemic Heart Failure (STICH)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Failure, Congestive, Heart Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H01: Medication
Arm Type
Active Comparator
Arm Description
Medical therapy alone to treat Coronary Artery Disease
Arm Title
H01: Medication + CABG
Arm Type
Active Comparator
Arm Description
Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease
Arm Title
H02: Medication+CABG
Arm Type
Active Comparator
Arm Description
Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease
Arm Title
H02: Medication+CABG+SVR
Arm Type
Active Comparator
Arm Description
CABG plus Medication and Surgical ventricular reconstruction (SVR)
Intervention Type
Procedure
Intervention Name(s)
CABG surgery plus MED
Intervention Description
CABG plus standard medication management for Coronary Artery Disease
Intervention Type
Drug
Intervention Name(s)
Active Medication Alone
Other Intervention Name(s)
Standard medications for management of CAD and heart failure
Intervention Description
Standard medication for coronary artery disease and heart failure management.
Intervention Type
Procedure
Intervention Name(s)
CABG plus MED and SVR
Intervention Description
H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone
Primary Outcome Measure Information:
Title
H01: All Cause Mortality
Time Frame
5 years post randomization
Title
H01: All Cause Mortality
Time Frame
10 years post randomization
Title
H02: All-cause Mortality or Cardiovascular Hospitalization
Time Frame
5 years post randomization
Secondary Outcome Measure Information:
Title
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
Time Frame
10 years post randomization
Title
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
Time Frame
5 years post randomization
Title
H01: Mortality or Cardiovascular Hospitalization
Time Frame
up to 5 years post randomization
Title
H01: Mortality or Cardiovascular Hospitalization
Time Frame
up to 10 years post randomization
Title
H02: All-cause Mortality
Time Frame
up to 5 years
Title
H01: All-cause Mortality Within 30 Days After Randomization
Time Frame
30 days post randomization
Title
H02: All-cause Mortality Within 30 Days After Randomization
Time Frame
30 days post randomization
Title
H01: All-cause Mortality or Heart-failure Hospitalization
Time Frame
5 years post randomization
Title
H02: All-cause Mortality or Heart-failure Hospitalization
Time Frame
5 years post randomization
Title
H01: All-cause Mortality or Heart-failure Hospitalization
Time Frame
10 years post randomization
Title
H01: Heart Failure Hospitalization
Time Frame
5 years post randomization
Title
H02: Heart Failure Hospitalization
Time Frame
5 years post randomization
Title
H01: Heart Failure Hospitalization
Time Frame
10 years post randomization
Title
H01: Cardiac Procedure: Heart Transplant
Time Frame
5 years post randomization
Title
H02: Cardiac Procedure: Heart Transplant
Time Frame
5 years post randomization
Title
H01: Cardiac Procedure: Heart Transplant
Time Frame
10 years post randomization
Title
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Time Frame
5 years post randomization
Title
H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Time Frame
5 years post randomization
Title
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Time Frame
10 years post randomization
Title
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Time Frame
5 years post randomization
Title
H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Time Frame
5 years post randomization
Title
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Time Frame
10 years post randomization
Title
H01: Stroke
Time Frame
5 years post randomization
Title
H01: Stroke
Time Frame
10 years post randomization
Title
H02: Stroke
Time Frame
5 years post randomization
Title
H01: All-cause Mortality or Revascularization (CABG or PCI)
Description
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Time Frame
5 years post randomization
Title
H02: All-cause Mortality or Revascularization (CABG or PCI)
Description
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Time Frame
5 years post randomization
Title
H01: All-cause Mortality or Revascularization (CABG or PCI)
Description
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Time Frame
10 years post randomization
Title
H01: All-cause Mortality, Heart Transplant or LVAD
Description
LVAD=Left Ventricular Assist Device
Time Frame
5 years post randomization
Title
H02: All-cause Mortality, Heart Transplant or LVAD
Time Frame
5 years post randomization
Title
H01: All-cause Mortality, Heart Transplant or LVAD
Description
LVAD=Left Ventricular Assist Device
Time Frame
10 years post randomization
Title
H01: All-cause (Unplanned and Elective) Hospitalization
Time Frame
5 years post randomization
Title
H02: All-cause (Unplanned and Elective) Hospitalization
Time Frame
5 years post randomization
Title
H01: All-cause (Unplanned and Elective) Hospitalization
Time Frame
10 years post randomization
Title
H01: 6 Minute Walk Distance
Time Frame
From randomization to 24 month follow-up
Title
H02: 6 Minute Walk Distance
Time Frame
From randomization to 24 month follow-up
Title
H01: Exercise Duration
Description
Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
Time Frame
From randomization to 24 months follow-up
Title
H02: Exercise Duration
Description
Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
Time Frame
From randomization to 24 months follow-up
Title
H01: LVEF by ECHO Core Lab During Follow-up
Description
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
Time Frame
From randomization to 24 months follow-up
Title
H02: LVEF by ECHO Core Lab During Follow-up
Description
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
Time Frame
From randomization to 24 months follow-up
Title
H01: LVEF by RN Core Lab During Follow-up
Description
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
Time Frame
From randomization to 24 months follow-up
Title
H02: LVEF by RN Core Lab During Follow-up
Description
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
Time Frame
From randomization to 24 months follow-up
Title
H01: LVEF by CMR Core Lab During Follow-up
Description
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
Time Frame
From randomization to 24 months follow-up
Title
H02: LVEF by CMR Core Lab During Follow-up
Description
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
Time Frame
From randomization to 24 months follow-up
Title
H01: B-type Natriuretic Peptide (BNP)
Description
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
Time Frame
From randomization to 24 months follow-up
Title
H02: B-type Natriuretic Peptide (BNP)
Description
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
Time Frame
From randomization to 24 months follow-up
Title
H01: SF-36 Mental Health Subscale
Description
Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time Frame
From enrollment to 3-year follow-up
Title
H02: SF-36 Mental Health Subscale
Description
These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time Frame
From enrollment to 3-year follow-up
Title
H01:SF-36 Role Physical Subscale
Description
These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time Frame
From enrollment to 3-year follow-up
Title
H02: SF-36 Role Physical Subscale
Description
These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time Frame
From enrollment to 3-year follow-up
Title
H01:SF-36 Role Emotional Subscale
Description
These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time Frame
From enrollment to 3-year follow-up
Title
H02: SF-36 Role Emotional Subscale
Description
These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time Frame
From enrollment to 3-year follow-up
Title
H01:SF-36 Social Functioning Subscale
Description
These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time Frame
From enrollment to 3-year follow-up
Title
H02: SF-36 Social Functioning Subscale
Description
These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time Frame
From enrollment to 3-year follow-up
Title
H01:SF-36 Vitality Subscale
Description
These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time Frame
From enrollment to 3-year follow-up
Title
H02: SF-36 Vitality Subscale
Description
These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Time Frame
From enrollment to 3-year follow-up
Title
H01:SF-12 Physical Component Summary (PCS) Scale
Description
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
Time Frame
From enrollment to 3-year follow-up
Title
H02: SF-12 Physical Component Summary (PCS) Scale
Description
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
Time Frame
From enrollment to 3-year follow-up
Title
H01: SF-12 Mental Component Summary (MCS) Scale
Description
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
Time Frame
From enrollment to 3-year follow-up
Title
H02: SF-12 Mental Component Summary (MCS) Scale
Description
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
Time Frame
From enrollment to 3-year follow-up
Title
H01: KCCQ Physical Limitation Scale
Description
Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: KCCQ Physical Limitation Scale
Description
These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time Frame
From enrollment to 3-year follow-up
Title
H01: KCCQ Symptom Stability
Description
This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: KCCQ Symptom Stability
Description
This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.
Time Frame
From enrollment to 3-year follow-up
Title
H01: KCCQ Symptom Frequency
Description
These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: KCCQ Symptom Frequency
Description
These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time Frame
From enrollment to 3-year follow-up
Title
H01: KCCQ Symptom Burden
Description
These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time Frame
From enrollment to 3-year follow-up
Title
H02: KCCQ Symptom Burden
Description
These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time Frame
From enrollment to 3-year follow-up
Title
H01: KCCQ Total Symptoms
Description
This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: KCCQ Total Symptoms
Description
This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time Frame
From enrollment to 3-year follow-up
Title
H01: KCCQ Quality-of-Life Scale
Description
These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: KCCQ Quality-of-Life Scale
Description
These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time Frame
From enrollment to 3-year follow-up
Title
H01: KCCQ Social Limitation
Description
These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: KCCQ Social Limitation
Description
These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time Frame
From enrollment to 3-year follow-up
Title
H01: KCCQ Clinical Summary Score
Description
This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: KCCQ Clinical Summary Score
Description
This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time Frame
From enrollment to 3-year follow-up
Title
H01: KCCQ Overall Summary Score
Description
This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: KCCQ Overall Summary Score
Description
This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time Frame
From enrollment to 3-year follow-up
Title
H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
Description
These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
Description
These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.
Time Frame
From enrollment to 3-year follow-up
Title
H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
Description
This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
Description
This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.
Time Frame
From enrollment to 3-year follow-up
Title
H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
Description
These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
Description
These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.
Time Frame
From enrollment to 3-year follow-up
Title
H01: EQ-5D Visual Analog Scale
Description
Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: EQ-5D Visual Analog Scale
Description
This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.
Time Frame
From enrollment to 3-year follow-up
Title
H01: EQ-5D Health Status Index Score
Description
This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: EQ-5D Health Status Index Score
Description
This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.)
Time Frame
From enrollment to 3-year follow-up
Title
H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
Description
These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
Description
These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.
Time Frame
From enrollment to 3-year follow-up
Title
H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
Description
These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
Description
These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
Time Frame
From enrollment to 3-year follow-up
Title
H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
Description
These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
Description
These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
Time Frame
From enrollment to 3-year follow-up
Title
H01: General Health Rating Scale
Description
This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health. .
Time Frame
From enrollment to 3-year follow-up
Title
H02: General Health Rating Scale
Description
This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.
Time Frame
From enrollment to 3-year follow-up
Title
H01: Cost of Care
Description
Hospital costs and physician fees for US patients
Time Frame
index hospital admission
Title
H02: Cost of Care
Description
Hospital costs and physician fees for US patients
Time Frame
index hospital admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bonow
Organizational Affiliation
Radionuclide Core Lab, Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arthur Feldman
Organizational Affiliation
Neurohormonal Core Lab, Jefferson University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Velazquez, MD
Organizational Affiliation
Clinical Coordinating Center, Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kerry Lee
Organizational Affiliation
Data Coordinating Center, Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Mark
Organizational Affiliation
Economics and Quality of Life Core Lab, Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Oh
Organizational Affiliation
Echocardiographic Core Lab, Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerald Pohost
Organizational Affiliation
Magnetic Resonance Imaging Core Lab, University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Rouleau
Organizational Affiliation
Université de Montréal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julio A Panza, MD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27715
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18023680
Citation
Velazquez EJ, Lee KL, O'Connor CM, Oh JK, Bonow RO, Pohost GM, Feldman AM, Mark DB, Panza JA, Sopko G, Rouleau JL, Jones RH; STICH Investigators. The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. J Thorac Cardiovasc Surg. 2007 Dec;134(6):1540-7. doi: 10.1016/j.jtcvs.2007.05.069.
Results Reference
background
PubMed Identifier
35044802
Citation
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Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease

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