STICH: Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
Study Details
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: H01: Medication Medical therapy alone to treat Coronary Artery Disease |
Drug: Active Medication Alone
Standard medication for coronary artery disease and heart failure management.
Other Names:
|
Active Comparator: H01: Medication + CABG Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease |
Procedure: CABG surgery plus MED
CABG plus standard medication management for Coronary Artery Disease
|
Active Comparator: H02: Medication+CABG Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease |
Procedure: CABG surgery plus MED
CABG plus standard medication management for Coronary Artery Disease
|
Active Comparator: H02: Medication+CABG+SVR CABG plus Medication and Surgical ventricular reconstruction (SVR) |
Procedure: CABG plus MED and SVR
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
|
Outcome Measures
Primary Outcome Measures
- H01: All Cause Mortality [5 years post randomization]
- H01: All Cause Mortality [10 years post randomization]
- H02: All-cause Mortality or Cardiovascular Hospitalization [5 years post randomization]
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). [10 years post randomization]
- H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). [5 years post randomization]
- H01: Mortality or Cardiovascular Hospitalization [up to 5 years post randomization]
- H01: Mortality or Cardiovascular Hospitalization [up to 10 years post randomization]
- H02: All-cause Mortality [up to 5 years]
- H01: All-cause Mortality Within 30 Days After Randomization [30 days post randomization]
- H02: All-cause Mortality Within 30 Days After Randomization [30 days post randomization]
- H01: All-cause Mortality or Heart-failure Hospitalization [5 years post randomization]
- H02: All-cause Mortality or Heart-failure Hospitalization [5 years post randomization]
- H01: All-cause Mortality or Heart-failure Hospitalization [10 years post randomization]
- H01: Heart Failure Hospitalization [5 years post randomization]
- H02: Heart Failure Hospitalization [5 years post randomization]
- H01: Heart Failure Hospitalization [10 years post randomization]
- H01: Cardiac Procedure: Heart Transplant [5 years post randomization]
- H02: Cardiac Procedure: Heart Transplant [5 years post randomization]
- H01: Cardiac Procedure: Heart Transplant [10 years post randomization]
- H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [5 years post randomization]
- H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [5 years post randomization]
- H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [10 years post randomization]
- H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [5 years post randomization]
- H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [5 years post randomization]
- H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [10 years post randomization]
- H01: Stroke [5 years post randomization]
- H01: Stroke [10 years post randomization]
- H02: Stroke [5 years post randomization]
- H01: All-cause Mortality or Revascularization (CABG or PCI) [5 years post randomization]
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) [5 years post randomization]
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) [10 years post randomization]
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 [5 years post randomization]
LVAD=Left Ventricular Assist Device
- H02: All-cause Mortality, Heart Transplant or LVAD [5 years post randomization]
- H01: All-cause Mortality, Heart Transplant or LVAD [10 years post randomization]
LVAD=Left Ventricular Assist Device
- H01: All-cause (Unplanned and Elective) Hospitalization [5 years post randomization]
- H02: All-cause (Unplanned and Elective) Hospitalization [5 years post randomization]
- H01: All-cause (Unplanned and Elective) Hospitalization [10 years post randomization]
- H01: 6 Minute Walk Distance [From randomization to 24 month follow-up]
- H02: 6 Minute Walk Distance [From randomization to 24 month follow-up]
- H01: Exercise Duration [From randomization to 24 months follow-up]
Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
- H02: Exercise Duration [From randomization to 24 months follow-up]
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 [From randomization to 24 months follow-up]
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
- H02: LVEF by ECHO Core Lab During Follow-up [From randomization to 24 months follow-up]
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
- H01: LVEF by RN Core Lab During Follow-up [From randomization to 24 months follow-up]
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
- H02: LVEF by RN Core Lab During Follow-up [From randomization to 24 months follow-up]
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
- H01: LVEF by CMR Core Lab During Follow-up [From randomization to 24 months follow-up]
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
- H02: LVEF by CMR Core Lab During Follow-up [From randomization to 24 months follow-up]
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
- H01: B-type Natriuretic Peptide (BNP) [From randomization to 24 months follow-up]
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
- H02: B-type Natriuretic Peptide (BNP) [From randomization to 24 months follow-up]
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
- H01: SF-36 Mental Health Subscale [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [From enrollment to 3-year follow-up]
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 [index hospital admission]
Hospital costs and physician fees for US patients
- H02: Cost of Care [index hospital admission]
Hospital costs and physician fees for US patients
Eligibility Criteria
Criteria
Inclusion Criteria:
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LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated single photon emission computed tomography (SPECT) studies
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Coronary anatomy suitable for revascularization
Exclusion Criteria:
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Failure to provide informed consent.
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Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement.
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Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.
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Plan for percutaneous intervention of CAD.
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Recent acute MI judged to be an important cause of left ventricular dysfunction.
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History of more than 1 prior coronary bypass operation.
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Noncardiac illness with a life expectancy of less than 3 years.
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Noncardiac illness imposing substantial operative mortality.
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Conditions/circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Duke University Medical Center | Durham | North Carolina | United States | 27715 |
Sponsors and Collaborators
- Duke University
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Robert Bonow, Radionuclide Core Lab, Northwestern University
- Principal Investigator: Arthur Feldman, Neurohormonal Core Lab, Jefferson University
- Principal Investigator: Eric Velazquez, MD, Clinical Coordinating Center, Duke University
- Principal Investigator: Kerry Lee, Data Coordinating Center, Duke University
- Principal Investigator: Daniel Mark, Economics and Quality of Life Core Lab, Duke University
- Principal Investigator: Jae Oh, Echocardiographic Core Lab, Mayo Clinic
- Principal Investigator: Gerald Pohost, Magnetic Resonance Imaging Core Lab, University of Southern California
- Study Chair: Jean Rouleau, Université de Montréal
- Principal Investigator: Julio A Panza, MD, Medstar Health Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Pro00018940
- U01HL069009
- U01HL069010
- U01HL069011
- U01HL069012
- U01HL069013
- U01HL069015
- U01HL072683
- R01HL105853
- Pro00010463
Study Results
Participant Flow
Recruitment Details | Pts were assigned to 1 of 3 strata before randomization. All pts in stratum C and some pts in stratum B were randomly assigned to med therapy + CABG or med therapy + CABG + SVR (Hypothesis 2 component of the trial-HO2). 76 of stratum B pts who were randomized to med therapy + CABG group belong to both H01 and H02. |
---|---|
Pre-assignment Detail | Stratum A: eligible for med. therapy alone or med therapy + CABG; Stratum C: eligible for med therapy + CABG or med therapy + CABG + SVR; Stratum B: eligible for all 3 treatment options. All pts in stratum A and some of the pts in stratum B were randomized to either med therapy alone or med therapy + CABG (Hypothesis 1 of the STICH trial--H01). |
Arm/Group Title | H01: Medication | H01: Medication + CABG | H01+H02: Medication + CABG | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|---|---|---|
Arm/Group Description | 50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | 50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Period Title: 5 Year Follow up | |||||
STARTED | 602 | 534 | 76 | 423 | 501 |
COMPLETED | 600 | 532 | 75 | 416 | 498 |
NOT COMPLETED | 2 | 2 | 1 | 7 | 3 |
Period Title: 5 Year Follow up | |||||
STARTED | 602 | 534 | 76 | 0 | 0 |
COMPLETED | 590 | 524 | 73 | 0 | 0 |
NOT COMPLETED | 12 | 10 | 3 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | H01: Medication | H01: Medication + CABG | H01+H02: Medication + CABG | H02: Medication+CABG | H02: Medication+CABG+SVR | Total |
---|---|---|---|---|---|---|
Arm/Group Description | 50% of H01 patients were randomized to this medical therapy alone arm. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | 50% of H01 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | This group includes those 76 patients who belong to both H01 and H02. These patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. | Total of all reporting groups |
Overall Participants | 602 | 534 | 76 | 423 | 501 | 2136 |
Age (years) [Median (Inter-Quartile Range) ] | ||||||
Median (Inter-Quartile Range) [years] |
59
|
60
|
61
|
62
|
62
|
60
|
Sex: Female, Male (Count of Participants) | ||||||
Female |
75
12.5%
|
64
12%
|
9
11.8%
|
69
16.3%
|
69
13.8%
|
286
13.4%
|
Male |
527
87.5%
|
470
88%
|
67
88.2%
|
354
83.7%
|
432
86.2%
|
1850
86.6%
|
Outcome Measures
Title | H01: All Cause Mortality |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
244
40.5%
|
218
40.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.12 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.86 | |
Confidence Interval |
(2-Sided) 95% 0.72 to 1.04 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H01: All Cause Mortality |
---|---|
Description | |
Time Frame | 10 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
398
66.1%
|
359
67.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.02 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.84 | |
Confidence Interval |
(2-Sided) 95% 0.73 to 0.97 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H02: All-cause Mortality or Cardiovascular Hospitalization |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H02: Medication+CABG+SVR | Total H02: Medication+CABG |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 501 | 499 |
Number [participants] |
289
48%
|
292
54.7%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.90 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.99 | |
Confidence Interval |
(2-Sided) 95% 0.84 to 1.17 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG) |
Title | H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). |
---|---|
Description | |
Time Frame | 10 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 610 | 602 |
Number [participants] |
247
41%
|
297
55.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.006 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio, log |
Estimated Value | 0.79 | |
Confidence Interval |
(2-Sided) 95% 0.66 to 0.93 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 610 | 602 |
Number [participants] |
168
27.9%
|
201
37.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.05 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.81 | |
Confidence Interval |
(2-Sided) 95% 0.66 to 1.00 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H01: Mortality or Cardiovascular Hospitalization |
---|---|
Description | |
Time Frame | up to 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
411
68.3%
|
351
65.7%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.74 | |
Confidence Interval |
(2-Sided) 95% 0.64 to 0.85 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H01: Mortality or Cardiovascular Hospitalization |
---|---|
Description | |
Time Frame | up to 10 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
524
87%
|
467
87.5%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.72 | |
Confidence Interval |
(2-Sided) 95% 0.64 to 0.82 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H02: All-cause Mortality |
---|---|
Description | |
Time Frame | up to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 499 | 501 |
Number [participants] |
141
23.4%
|
138
25.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.98 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.00 | |
Confidence Interval |
(2-Sided) 95% 0.79 to 1.26 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG) |
Title | H01: All-cause Mortality Within 30 Days After Randomization |
---|---|
Description | |
Time Frame | 30 days post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
7
1.2%
|
22
4.1%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.008 |
Comments | ||
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 3.19 | |
Confidence Interval |
(2-Sided) 95% 1.35 to 7.52 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Odds Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H02: All-cause Mortality Within 30 Days After Randomization |
---|---|
Description | |
Time Frame | 30 days post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 499 | 501 |
Number [participants] |
22
3.7%
|
30
5.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.275 |
Comments | ||
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 1.37 | |
Confidence Interval |
(2-Sided) 95% 0.78 to 2.41 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Odds Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG) |
Title | H01: All-cause Mortality or Heart-failure Hospitalization |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
324
53.8%
|
290
54.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.030 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.84 | |
Confidence Interval |
(2-Sided) 95% 0.71 to 0.98 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H02: All-cause Mortality or Heart-failure Hospitalization |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 499 | 501 |
Number [participants] |
211
35%
|
214
40.1%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.401 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.08 | |
Confidence Interval |
(2-Sided) 95% 0.89 to 1.31 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG) |
Title | H01: All-cause Mortality or Heart-failure Hospitalization |
---|---|
Description | |
Time Frame | 10 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
450
74.8%
|
404
75.7%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.81 | |
Confidence Interval |
(2-Sided) 95% 0.71 to 0.93 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H01: Heart Failure Hospitalization |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
169
28.1%
|
127
23.8%
|
Title | H02: Heart Failure Hospitalization |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 499 | 501 |
Number [participants] |
95
15.8%
|
99
18.5%
|
Title | H01: Heart Failure Hospitalization |
---|---|
Description | |
Time Frame | 10 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
201
33.4%
|
157
29.4%
|
Title | H01: Cardiac Procedure: Heart Transplant |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
3
0.5%
|
0
0%
|
Title | H02: Cardiac Procedure: Heart Transplant |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 499 | 501 |
Number [participants] |
2
0.3%
|
7
1.3%
|
Title | H01: Cardiac Procedure: Heart Transplant |
---|---|
Description | |
Time Frame | 10 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
4
0.7%
|
1
0.2%
|
Title | H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
2
0.3%
|
2
0.4%
|
Title | H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD) |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 499 | 501 |
Number [participants] |
2
0.3%
|
2
0.4%
|
Title | H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) |
---|---|
Description | |
Time Frame | 10 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
2
0.3%
|
4
0.7%
|
Title | H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
98
16.3%
|
76
14.2%
|
Title | H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 499 | 501 |
Number [participants] |
100
16.6%
|
86
16.1%
|
Title | H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) |
---|---|
Description | |
Time Frame | 10 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
118
19.6%
|
105
19.7%
|
Title | H01: Stroke |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
34
5.6%
|
41
7.7%
|
Title | H01: Stroke |
---|---|
Description | |
Time Frame | 10 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
41
6.8%
|
47
8.8%
|
Title | H02: Stroke |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 499 | 501 |
Number [participants] |
31
5.1%
|
23
4.3%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
333
55.3%
|
237
44.4%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.60 | |
Confidence Interval |
(2-Sided) 95% 0.51 to 0.71 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
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 |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 499 | 501 |
Number [participants] |
174
28.9%
|
152
28.5%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.414 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.91 | |
Confidence Interval |
(2-Sided) 95% 0.73 to 1.13 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG) |
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 |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
478
79.4%
|
388
72.7%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.63 | |
Confidence Interval |
(2-Sided) 95% 0.55 to 0.73 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H01: All-cause Mortality, Heart Transplant or LVAD |
---|---|
Description | LVAD=Left Ventricular Assist Device |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
245
40.7%
|
218
40.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.108 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.86 | |
Confidence Interval |
(2-Sided) 95% 0.72 to 1.03 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H02: All-cause Mortality, Heart Transplant or LVAD |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 499 | 501 |
Number [participants] |
148
24.6%
|
145
27.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.717 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.05 | |
Confidence Interval |
(2-Sided) 95% 0.83 to 1.32 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG) |
Title | H01: All-cause Mortality, Heart Transplant or LVAD |
---|---|
Description | LVAD=Left Ventricular Assist Device |
Time Frame | 10 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
400
66.4%
|
361
67.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.018 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.84 | |
Confidence Interval |
(2-Sided) 95% 0.73 to 0.97 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication) |
Title | H01: All-cause (Unplanned and Elective) Hospitalization |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
340
56.5%
|
290
54.3%
|
Title | H02: All-cause (Unplanned and Elective) Hospitalization |
---|---|
Description | |
Time Frame | 5 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 499 | 501 |
Number [participants] |
272
45.2%
|
268
50.2%
|
Title | H01: All-cause (Unplanned and Elective) Hospitalization |
---|---|
Description | |
Time Frame | 10 years post randomization |
Outcome Measure Data
Analysis Population Description |
---|
The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 602 | 610 |
Number [participants] |
383
63.6%
|
349
65.4%
|
Title | H01: 6 Minute Walk Distance |
---|---|
Description | |
Time Frame | From randomization to 24 month follow-up |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 559 | 552 |
Baseline |
333.97
(117.76)
|
333.04
(117.06)
|
4 month |
364.25
(111.24)
|
376.46
(118.87)
|
Changed from baseline to 4 months |
28.2
(102.44)
|
37.76
(108.93)
|
24 month |
381.55
(120.86)
|
377.84
(122.62)
|
Change from baseline to 24 Months |
34.11
(112.9)
|
31.18
(128.99)
|
Title | H02: 6 Minute Walk Distance |
---|---|
Description | |
Time Frame | From randomization to 24 month follow-up |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with 6-minute walk distance data at baseline, 4 months or 24 months were analyzed. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | H02 patients were randomized to medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H02: Medication + CABG group includes the H02: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm. |
Measure Participants | 420 | 429 |
Baseline |
339.38
(126.11)
|
357.23
(116.91)
|
4 month |
385.89
(123.49)
|
407.03
(121.38)
|
Changed from baseline to 4 months |
44.42
(122.64)
|
46.09
(113.67)
|
24 month |
400.66
(121.67)
|
425.18
(121.46)
|
Change from baseline to 24 Months |
51.51
(125.65)
|
55.6
(112.66)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with exercise duration data at baseline or 24 months were analyzed. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 269 | 242 |
Baseline |
6.85
(3.4)
|
6.3
(3.39)
|
24 month |
7.78
(3.32)
|
7.97
(3.32)
|
Change from baseline to 24 Months |
0.71
(3.51)
|
0.83
(3.26)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with exercise duration data at baseline or 24 months were analyzed. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | ||
Measure Participants | 119 | 138 |
Baseline |
6.19
(3.42)
|
7.16
(3.47)
|
24 month |
7.67
(3.3)
|
8.41
(3.41)
|
Change from baseline to 24 Months |
1.15
(3.01)
|
0.47
(3.42)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 584 | 589 |
Baseline |
28.69
(8.33)
|
28.43
(8.24)
|
4 month |
30.83
(9.41)
|
30.66
(10.73)
|
Changed from baseline to 4 months |
2.21
(8.8)
|
2.06
(10.06)
|
24 month |
31.39
(10.75)
|
31.15
(11.14)
|
Change from baseline to 24 Months |
2.2
(11.31)
|
2.22
(10.67)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with ECHO LVEF data at baseline, 4 months or 24 months were analyzed. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | ||
Measure Participants | 484 | 484 |
Baseline |
29.13
(7.74)
|
29.49
(8.23)
|
4 month |
31.47
(10.4)
|
33.35
(9.79)
|
Changed from baseline to 4 months |
2.16
(10.23)
|
3.04
(9.7)
|
24 month |
31.89
(11.38)
|
33.55
(10.91)
|
Change from baseline to 24 Months |
2.24
(11.11)
|
2.93
(10.95)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 250 | 255 |
Baseline |
26.83
(8.66)
|
26.66
(8.41)
|
4 month |
27.2
(9.5)
|
27.81
(9.73)
|
Changed from baseline to 4 months |
0.99
(5.88)
|
2.65
(6.36)
|
24 month |
30.65
(10.74)
|
27.79
(9.05)
|
Change from baseline to 24 Months |
3.99
(8.24)
|
1.77
(5.63)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with RN LVEF data at Baseline, 4-months or 24-months were analyzed. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | ||
Measure Participants | 214 | 216 |
Baseline |
27.14
(8.18)
|
26.55
(7.83)
|
4 month |
30.65
(10.41)
|
33.5
(9.42)
|
Changed from baseline to 4 months |
2.23
(7.11)
|
6.49
(7.91)
|
24 month |
29.95
(10.97)
|
34.2
(10.3)
|
Change from baseline to 24 Months |
2.01
(9.58)
|
6.79
(9.12)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 50 | 68 |
Baseline |
29.51
(11.02)
|
23.35
(9.49)
|
4 month |
28.6
(11.11)
|
28.63
(13.16)
|
Changed from baseline to 4 months |
0.07
(8.82)
|
2.85
(12.87)
|
24 month |
32.72
(14.7)
|
31.47
(9.06)
|
Change from baseline to 24 Months |
-1.09
(10.63)
|
2.13
(13.27)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with CMR LVEF data at baseline, 4 months or 24 months were analyzed. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 207 | 196 |
Baseline |
27.82
(10.26)
|
27.25
(11.47)
|
4 month |
31.65
(13.53)
|
34.37
(13.41)
|
Changed from baseline to 4 months |
2.84
(11.86)
|
7.1
(11.86)
|
24 month |
28.46
(10.57)
|
33.1
(13.79)
|
Change from baseline to 24 Months |
-0.51
(14.61)
|
5.39
(13.23)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with BNP data at baseline or 4 months were analyzed. |
Arm/Group Title | H01: Medication | Total H01: Medication + CABG |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. |
Measure Participants | 314 | 325 |
Baseline |
497.29
(627.49)
|
478.73
(521.11)
|
4 month |
408.69
(413.27)
|
484.39
(554.42)
|
Changed from baseline to 4 months |
-20.65
(405.44)
|
33.37
(566.62)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with BNP data at baseline or 4 months were analyzed. |
Arm/Group Title | Total H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | ||
Measure Participants | 386 | 392 |
Baseline |
453.73
(563.1)
|
452.45
(665.06)
|
4 month |
460.14
(508.35)
|
467.83
(579.42)
|
Changed from baseline to 4 months |
19.75
(600.26)
|
72.23
(554.2)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 597 | 584 |
Baseline |
43.7
(11.8)
|
44.4
(11.8)
|
4 Months |
48.2
(10.2)
|
47.2
(11.2)
|
12 Months |
48.8
(11.1)
|
47.0
(11.8)
|
24 Months |
48.6
(10.5)
|
46.8
(11.8)
|
36 Months |
48.5
(11.1)
|
48.2
(10.8)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.015 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.011 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.44 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 489 | 481 |
Baseline |
41
|
41
|
4 Months |
50
|
50
|
12 Months |
53
|
50
|
24 Months |
50
|
50
|
36 Months |
50
|
50
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.91 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.62 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.04 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.96 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.78 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 581 | 569 |
Baseline |
36.1
(10.9)
|
36.6
(11.2)
|
4 Months |
43.0
(11.8)
|
42.6
(11.8)
|
12 Months |
45.7
(11.4)
|
43.1
(12.2)
|
24 Months |
46.6
(11.4)
|
44.7
(12.2)
|
36 Months |
46.0
(11.2)
|
44.8
(11.6)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.31 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | 24 months | |
Statistical Test of Hypothesis | p-Value | 0.028 |
Comments | ||
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.079 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 466 | 466 |
Baseline |
28
|
28
|
4 Months |
42
|
42
|
12 Months |
49
|
49
|
24 Months |
49
|
49
|
36 Months |
49
|
56
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.74 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.61 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.78 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.94 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.29 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 588 | 582 |
Baseline |
39.0
(14.2)
|
40.0
(14.4)
|
4 Months |
45.3
(13.2)
|
44.6
(13.4)
|
12 Months |
46.4
(12.8)
|
45.9
(13.3)
|
24 Months |
47.5
(12.1)
|
46.8
(12.8)
|
36 Months |
48.0
(11.8)
|
47.0
(12.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.063 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.187 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.168 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.050 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 482 | 477 |
Baseline |
34
|
34
|
4 Months |
55
|
55
|
12 Months |
55
|
55
|
24 Months |
55
|
55
|
36 Months |
55
|
55
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.82 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.48 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.69 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.63 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.90 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 601 | 588 |
Baseline |
41.8
(12.0)
|
42.1
(12.0)
|
4 Months |
47.0
(11.1)
|
45.8
(11.3)
|
12 Months |
48.7
(10.4)
|
46.1
(11.7)
|
24 Months |
48.3
(9.9)
|
46.1
(11.1)
|
36 Months |
47.8
(10.3)
|
47.1
(10.2)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.039 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.008 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.31 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 490 | 485 |
Baseline |
41
|
35
|
4 Months |
52
|
52
|
12 Months |
52
|
52
|
24 Months |
52
|
52
|
36 Months |
52
|
52
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.36 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.87 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.17 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.12 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.79 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 598 | 586 |
Baseline |
46.4
(10.3)
|
47.5
(10.9)
|
4 Months |
51.6
(9.8)
|
50.5
(10.5)
|
12 Months |
52.2
(10.1)
|
49.9
(10.9)
|
24 Months |
51.9
(9.9)
|
49.4
(10.5)
|
36 Months |
51.4
(10.0)
|
50.6
(10.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 4 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.024 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 489 | 480 |
Baseline |
44
|
44
|
4 Months |
51
|
51
|
12 Months |
53
|
51
|
24 Months |
51
|
51
|
36 Months |
51
|
51
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.31 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.42 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.66 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.32 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.43 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 534 | 530 |
Baseline |
37.8
(6.1)
|
38.4
(5.7)
|
4 Months |
40.2
(5.9)
|
39.9
(5.8)
|
12 Months |
41.0
(5.3)
|
40.0
(6.0)
|
24 Months |
41.3
(5.7)
|
40.9
(5.8)
|
36 Months |
40.8
(5.5)
|
41.3
(5.8)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.051 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.003 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.065 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.83 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 433 | 426 |
Baseline |
37
|
37
|
4 Months |
40
|
40
|
12 Months |
41
|
41
|
24 Months |
41
|
41
|
36 Months |
40
|
41
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.71 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.57 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.15 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.64 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.07 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 534 | 530 |
Baseline |
44.6
(12.6)
|
45.5
(13.0)
|
4 Months |
50.5
(11.8)
|
49.2
(12.3)
|
12 Months |
51.8
(12.1)
|
50.3
(12.6)
|
24 Months |
51.6
(11.1)
|
49.7
(12.6)
|
36 Months |
51.6
(11.4)
|
50.9
(11.9)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.004 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.011 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.007 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.044 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 433 | 426 |
Baseline |
42
|
41
|
4 Months |
54
|
55
|
12 Months |
57
|
54
|
24 Months |
56
|
55
|
36 Months |
56
|
56
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.74 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.87 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.03 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.60 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.87 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 597 | 585 |
Baseline |
64.2
(24.7)
|
64.7
(26.1)
|
4 Months |
75.2
(23.6)
|
73.1
(23.6)
|
12 Months |
77.8
(23.0)
|
73.4
(24.3)
|
24 Months |
76.6
(23.1)
|
73.1
(25.4)
|
36 Months |
76.8
(22.0)
|
74.9
(22.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.050 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.003 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | 24 months | |
Statistical Test of Hypothesis | p-Value | 0.049 |
Comments | ||
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.097 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 484 | 480 |
Baseline |
63
|
63
|
4 Months |
83
|
83
|
12 Months |
84
|
88
|
24 Months |
88
|
85
|
36 Months |
88
|
88
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.40 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.13 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.86 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.89 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.87 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 604 | 590 |
Baseline |
53.3
(23.3)
|
55.5
(23.8)
|
4 Months |
58.6
(20.5)
|
55.7
(19.1)
|
12 Months |
52.8
(15.7)
|
51.1
(17.4)
|
24 Months |
51.7
(14.5)
|
49.3
(15.5)
|
36 Months |
50.7
(14.4)
|
50.8
(14.2)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.005 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.023 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.009 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.26 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 494 | 492 |
Baseline |
50
|
50
|
4 Months |
50
|
50
|
12 Months |
50
|
50
|
24 Months |
50
|
50
|
36 Months |
50
|
50
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.38 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.45 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.62 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.82 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.94 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 606 | 592 |
Baseline |
70.5
(24.6)
|
71.5
(25.7)
|
4 Months |
79.8
(21.6)
|
79.1
(21.8)
|
12 Months |
82.4
(22.2)
|
79.2
(23.5)
|
24 Months |
82.2
(20.9)
|
79.3
(23.3)
|
36 Months |
81.7
(22.7)
|
80.4
(22.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.205 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.017 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.028 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.123 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 493 | 491 |
Baseline |
67
|
71
|
4 Months |
83
|
88
|
12 Months |
90
|
90
|
24 Months |
92
|
92
|
36 Months |
92
|
92
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.19 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.07 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.94 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.67 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.44 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 606 | 591 |
Baseline |
72.6
(22.5)
|
73.4
(24.4)
|
4 Months |
81.4
(20.4)
|
79.6
(21.0)
|
12 Months |
83.7
(20.6)
|
79.8
(22.5)
|
24 Months |
83.3
(20.2)
|
80.0
(23.1)
|
36 Months |
83.1
(21.2)
|
80.7
(22.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.050 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.006 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.039 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.074 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 494 | 492 |
Baseline |
67
|
75
|
4 Months |
83
|
83
|
12 Months |
92
|
92
|
24 Months |
92
|
92
|
36 Months |
92
|
92
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.23 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.43 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.35 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.90 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.48 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 606 | 592 |
Baseline |
71.7
(22.5)
|
72.6
(24.2)
|
4 Months |
80.8
(20.0)
|
79.5
(20.5)
|
12 Months |
83.2
(20.5)
|
79.6
(22.1)
|
24 Months |
82.9
(19.8)
|
79.8
(22.6)
|
36 Months |
82.5
(21.3)
|
80.7
(21.7)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.085 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.007 |
Comments | ||
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.026 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.085 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 494 | 492 |
Baseline |
68
|
71
|
4 Months |
84
|
88
|
12 Months |
90
|
88
|
24 Months |
90
|
90
|
36 Months |
90
|
92
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.18 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.17 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.59 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.78 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.48 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 606 | 591 |
Baseline |
47.9
(25.0)
|
50.1
(27.0)
|
4 Months |
68.7
(24.5)
|
63.3
(25.6)
|
12 Months |
72.9
(23.5)
|
65.6
(25.8)
|
24 Months |
71.9
(22.6)
|
66.9
(26.0)
|
36 Months |
71.2
(23.3)
|
69.1
(24.8)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 12 month | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.018 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 493 | 490 |
Baseline |
42
|
33
|
4 Months |
75
|
75
|
12 Months |
75
|
75
|
24 Months |
75
|
75
|
36 Months |
75
|
83
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.70 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.47 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.87 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.84 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.82 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 570 | 554 |
Baseline |
56.4
(29.9)
|
57.3
(29.7)
|
4 Months |
72.3
(27.4)
|
69.0
(27.0)
|
12 Months |
76.4
(26.0)
|
69.5
(28.4)
|
24 Months |
75.4
(25.9)
|
71.0
(28.8)
|
36 Months |
75.4
(27.0)
|
72.8
(26.8)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.023 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.001 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.077 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.170 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 465 | 467 |
Baseline |
44
|
44
|
4 Months |
75
|
75
|
12 Months |
81
|
83
|
24 Months |
81
|
86
|
36 Months |
83
|
83
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.63 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.29 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.68 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.25 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.68 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 607 | 592 |
Baseline |
68.2
(21.8)
|
68.8
(23.1)
|
4 Months |
78.2
(20.0)
|
76.4
(20.4)
|
12 Months |
80.6
(20.3)
|
76.4
(21.9)
|
24 Months |
80.1
(19.5)
|
76.6
(22.6)
|
36 Months |
79.9
(20.2)
|
78.0
(20.5)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.033 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.015 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.051 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 496 | 492 |
Baseline |
65
|
68
|
4 Months |
84
|
84
|
12 Months |
88
|
86
|
24 Months |
88
|
87
|
36 Months |
88
|
88
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.26 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.23 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.66 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.98 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.86 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 607 | 592 |
Baseline |
60.3
(22.3)
|
61.3
(23.2)
|
4 Months |
74.3
(21.0)
|
71.2
(21.3)
|
12 Months |
77.5
(20.4)
|
72.2
(22.7)
|
24 Months |
76.9
(20.1)
|
72.9
(23.4)
|
36 Months |
76.6
(20.9)
|
74.5
(21.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | ||
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.006 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.037 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 496 | 492 |
Baseline |
53
|
54
|
4 Months |
79
|
79
|
12 Months |
84
|
82
|
24 Months |
84
|
84
|
36 Months |
85
|
84
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.53 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.26 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.76 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.89 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.89 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 594 | 584 |
Baseline |
74.3
(26.7)
|
77.0
(26.2)
|
4 Months |
90.5
(16.9)
|
84.0
(23.2)
|
12 Months |
90.6
(16.5)
|
84.0
(22.4)
|
24 Months |
90.5
(17.2)
|
86.5
(19.7)
|
36 Months |
89.8
(17.5)
|
88.5
(19.0)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.010 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 488 | 482 |
Baseline |
70
|
80
|
4 Months |
100
|
100
|
12 Months |
100
|
100
|
24 Months |
100
|
100
|
36 Months |
100
|
100
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.01 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.74 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.77 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.46 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.27 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 575 | 565 |
Baseline |
56.0
(27.1)
|
57.8
(25.0)
|
4 Months |
58.3
(20.3)
|
55.8
(20.6)
|
12 Months |
55.4
(17.3)
|
53.3
(17.6)
|
24 Months |
52.9
(14.9)
|
52.9
(17.4)
|
36 Months |
53.9
(16.9)
|
53.6
(15.5)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.029 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.042 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.30 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.20 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 477 | 462 |
Baseline |
50
|
50
|
4 Months |
50
|
50
|
12 Months |
50
|
50
|
24 Months |
50
|
50
|
36 Months |
50
|
50
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.98 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.16 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.88 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.95 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.48 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 585 | 574 |
Baseline |
53.6
(25.9)
|
57.6
(26.6)
|
4 Months |
74.5
(22.1)
|
67.5
(24.4)
|
12 Months |
75.8
(21.2)
|
69.1
(24.0)
|
24 Months |
75.5
(21.5)
|
68.7
(24.9)
|
36 Months |
75.3
(22.1)
|
72.9
(22.2)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.001 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 484 | 478 |
Baseline |
42
|
42
|
4 Months |
83
|
83
|
12 Months |
83
|
83
|
24 Months |
83
|
83
|
36 Months |
83
|
83
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.86 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.39 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.65 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.15 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.68 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 593 | 585 |
Baseline |
56.7
(19.0)
|
59.5
(18.8)
|
4 Months |
68.5
(18.1)
|
65.4
(17.7)
|
12 Months |
69.2
(17.9)
|
65.4
(18.5)
|
24 Months |
68.6
(17.8)
|
65.9
(18.4)
|
36 Months |
69.0
(17.9)
|
67.1
(17.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.001 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.001 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.001 |
Comments | ||
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 488 | 487 |
Baseline |
50
|
50
|
4 Months |
70
|
70
|
12 Months |
72
|
70
|
24 Months |
70
|
70
|
36 Months |
70
|
70
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.96 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.53 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.37 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.78 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.21 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 584 | 570 |
Baseline |
69.3
(25.8)
|
72.3
(24.4)
|
4 Months |
78.9
(24.5)
|
77.4
(22.6)
|
12 Months |
80.5
(22.3)
|
77.6
(24.0)
|
24 Months |
79.6
(24.6)
|
78.1
(25.9)
|
36 Months |
81.4
(23.4)
|
81.5
(21.6)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.007 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.003 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.023 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.060 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 475 | 477 |
Baseline |
69
|
69
|
4 Months |
85
|
85
|
12 Months |
85
|
85
|
24 Months |
85
|
85
|
36 Months |
85
|
85
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.31 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.43 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.57 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.95 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.38 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 595 | 583 |
Baseline |
42.9
7.1%
|
43.4
8.1%
|
4 Months |
26.6
4.4%
|
27.5
5.1%
|
12 Months |
25.0
4.2%
|
26.9
5%
|
24 Months |
24.1
4%
|
31.1
5.8%
|
36 Months |
22.4
3.7%
|
29.5
5.5%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.86 |
Comments | Baseline | |
Method | Chi-squared | |
Comments | All P-values were based on the Likelihood Ratio Chi-Square test. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.78 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | All P-values were based on the Likelihood Ratio Chi-Square test. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.55 |
Comments | 12 months | |
Method | Chi-squared | |
Comments | All P-values were based on the Likelihood Ratio Chi-Square test. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.027 |
Comments | 24 months | |
Method | Chi-squared | |
Comments | All P-values were based on the Likelihood Ratio Chi-Square test. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.031 |
Comments | 36 months | |
Method | Chi-squared | |
Comments | All P-values were based on the Likelihood Ratio Chi-Square test. |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 496 | 495 |
Baseline |
50.5
8.4%
|
53.2
10%
|
4 Months |
29.6
4.9%
|
27.0
5.1%
|
12 Months |
24.4
4.1%
|
27.0
5.1%
|
24 Months |
28.1
4.7%
|
24.3
4.6%
|
36 Months |
20.8
3.5%
|
24.8
4.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.40 |
Comments | Baseline | |
Method | Chi-squared | |
Comments | All P-values were based on the Likelihood Ratio Chi-Square test. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.42 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | All P-values were based on the Likelihood Ratio Chi-Square test. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.41 |
Comments | 12 months | |
Method | Chi-squared | |
Comments | All P-values were based on the Likelihood Ratio Chi-Square test. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.25 |
Comments | 24 months | |
Method | Chi-squared | |
Comments | All P-values were based on the Likelihood Ratio Chi-Square test. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.25 |
Comments | 36 months | |
Method | Chi-squared | |
Comments | All P-values were based on the Likelihood Ratio Chi-Square test. |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 596 | 581 |
Baseline |
46.8
(24.3)
|
49.3
(24.9)
|
4 Months |
56.0
(25.0)
|
53.8
(24.8)
|
12 Months |
56.7
(25.9)
|
53.9
(26.7)
|
24 Months |
55.3
(25.2)
|
53.3
(26.4)
|
36 Months |
56.2
(26.0)
|
54.9
(26.7)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.007 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.049 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.038 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 487 | 481 |
Baseline |
45
|
45
|
4 Months |
61
|
63
|
12 Months |
65
|
64
|
24 Months |
63
|
65
|
36 Months |
58
|
63
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.40 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.37 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.98 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.15 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.04 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 599 | 583 |
Baseline |
62.9
(22.5)
|
64.8
(21.2)
|
4 Months |
69.2
(20.6)
|
68.7
(20.5)
|
12 Months |
68.7
(20.3)
|
67.4
(21.8)
|
24 Months |
68.3
(20.4)
|
66.2
(21.3)
|
36 Months |
69.7
(21.0)
|
68.3
(21.1)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.036 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.043 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.018 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.037 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 487 | 482 |
Baseline |
63
|
63
|
4 Months |
75
|
75
|
12 Months |
75
|
75
|
24 Months |
75
|
75
|
36 Months |
75
|
75
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.75 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.72 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.77 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.52 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.12 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | Total H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | H01 patients were randomized to medical therapy plus CABG. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. The Total H01: Medication + CABG group includes the H01: Medication + CABG group and those 76 patients who belong to H01+H02: Medication + CABG arm. | H01 patients were randomized to medical therapy alone. Throughout the trial follow-up period, the use of guideline-recommended medications and devices for the treatment of heart failure and CAD was strongly emphasized for all patients in this treatment arm. |
Measure Participants | 579 | 554 |
Baseline |
56.0
(19.4)
|
57.6
(19.0)
|
4 Months |
67.3
(19.1)
|
64.0
(18.1)
|
12 Months |
68.7
(18.7)
|
63.7
(19.1)
|
24 Months |
68.1
(19.2)
|
65.0
(19.6)
|
36 Months |
69.1
(31.6)
|
67.1
(33.7)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0002 |
Comments | 4 months | |
Method | Chi-squared | |
Comments | H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | 12 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.009 |
Comments | 24 months | |
Method | Chi-squared | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.32 |
Comments | 36 months | |
Method | Chi-squared | |
Comments |
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 |
Outcome Measure Data
Analysis Population Description |
---|
Only patients with questionnaire data were analyzed. |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | 50% of H02 patients were randomized to this medical therapy plus CABG arm. In addition to the guideline-recommended medications, coronary artery bypass graft (CABG) surgery was to be performed for patients randomized to this treatment arm. This group does not include those 76 patients who belong to both H01 and H02. | 50% of H02 patients were randomized to this medical therapy plus CABG plus SVR arm. In addition to the guideline-recommended medications, both the coronary artery bypass graft (CABG) surgery and the surgical ventricular reconstruction (SVR) were to be performed for patients randomized to this treatment arm |
Measure Participants | 466 | 458 |
Baseline |
50
|
50
|
4 Months |
70
|
70
|
12 Months |
70
|
70
|
24 Months |
70
|
70
|
36 Months |
70
|
70
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.60 |
Comments | Baseline | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.14 |
Comments | 4 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.57 |
Comments | 12 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.15 |
Comments | 24 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.84 |
Comments | 36 months | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Title | H01: Cost of Care |
---|---|
Description | Hospital costs and physician fees for US patients |
Time Frame | index hospital admission |
Outcome Measure Data
Analysis Population Description |
---|
US patients with hospital bills |
Arm/Group Title | H01: Medication + CABG | H01: Medication |
---|---|---|
Arm/Group Description | Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease CABG surgery plus MED (medication): CABG plus standard medication management for Coronary Artery Disease | Medical therapy alone to treat Coronary Artery Disease Active Medication Alone: Standard medication for coronary artery disease and heart failure management. |
Measure Participants | 66 | 54 |
Hospital Costs |
50,032
(41,622)
|
8,315
(19,719)
|
Physician Fees |
5,405
(2,377)
|
408
(819)
|
Total Index Cost |
55,437
(43,460)
|
8,723
(20,506)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | Hospital costs | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | Physician fees | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | Total index cost | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Title | H02: Cost of Care |
---|---|
Description | Hospital costs and physician fees for US patients |
Time Frame | index hospital admission |
Outcome Measure Data
Analysis Population Description |
---|
US patients with hospital bills |
Arm/Group Title | H02: Medication+CABG | H02: Medication+CABG+SVR |
---|---|---|
Arm/Group Description | Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease CABG surgery plus MED: CABG plus standard medication management for Coronary Artery Disease | CABG plus Medication and Surgical ventricular reconstruction (SVR) CABG plus MED and SVR: 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 |
Measure Participants | 100 | 96 |
Hospital Costs |
50,939
(46,458)
|
64,202
(49,172)
|
Physician Fees |
5,183
(2,306)
|
6,515
(2,463)
|
Total Index Cost |
56,122
(48,552)
|
70,717
(51,367)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.006 |
Comments | Hospital costs | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | Physician fees | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | H01: Medication, Total H01: Medication + CABG |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.004 |
Comments | Total index cost | |
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Adverse Events
Time Frame | No "other" adverse events were collected, however serious adverse events were collected for the first 5 years of the follow up period per study protocol. | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||||
Arm/Group Title | H01: Medication | H01: Medication + CABG | H01 & H02: Medication+CABG | H02: Medication+CABG | H02: Medication+CABG+SVR | |||||
Arm/Group Description | ||||||||||
All Cause Mortality |
||||||||||
H01: Medication | H01: Medication + CABG | H01 & H02: Medication+CABG | H02: Medication+CABG | H02: Medication+CABG+SVR | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
H01: Medication | H01: Medication + CABG | H01 & H02: Medication+CABG | H02: Medication+CABG | H02: Medication+CABG+SVR | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 84/602 (14%) | 85/534 (15.9%) | 9/76 (11.8%) | 31/423 (7.3%) | 53/501 (10.6%) | |||||
Blood and lymphatic system disorders | ||||||||||
HEPARIN-INDUCED THROMBOCYTOPENIA | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 2/501 (0.4%) | |||||
LEUKOCYTOSIS | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Cardiac disorders | ||||||||||
ACUTE CORONARY SYNDROME | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
ACUTE HEART FAILURE | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
ACUTE LEFT VENTRICULAR FAILURE | 2/602 (0.3%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
ACUTE MYOCARDIAL INFARCTION | 1/602 (0.2%) | 4/534 (0.7%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
ANGINA PECTORIS | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
ANGINAL DISCOMFORT | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
ARRHYTHMIA | 6/602 (1%) | 7/534 (1.3%) | 0/76 (0%) | 1/423 (0.2%) | 4/501 (0.8%) | |||||
ASYSTOLIA | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
ATRIAL FIBRILLATION | 1/602 (0.2%) | 1/534 (0.2%) | 0/76 (0%) | 2/423 (0.5%) | 0/501 (0%) | |||||
CARDIAC ARREST | 5/602 (0.8%) | 5/534 (0.9%) | 0/76 (0%) | 0/423 (0%) | 2/501 (0.4%) | |||||
CARDIAC ARRHYTHMIA | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
CARDIAC DISORDER | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
CARDIAC FAILURE | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
CARDIAC FAILURE ACUTE | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
CARDIAC FAILURE AGGRAVATED | 2/602 (0.3%) | 0/534 (0%) | 0/76 (0%) | 1/423 (0.2%) | 1/501 (0.2%) | |||||
CARDIAC TAMPONADE | 1/602 (0.2%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
CARDIAC VENTRICULAR THROMBOSIS | 0/602 (0%) | 0/534 (0%) | 1/76 (1.3%) | 0/423 (0%) | 0/501 (0%) | |||||
CARDIOGENIC SHOCK | 3/602 (0.5%) | 3/534 (0.6%) | 0/76 (0%) | 2/423 (0.5%) | 2/501 (0.4%) | |||||
CARDIOPULMONARY INSUFFICIENCY | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
CARDIOVASCULAR INSUFFICIENCY | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
CONGESTIVE CARDIAC FAILURE | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
CONGESTIVE HEART FAILURE | 3/602 (0.5%) | 2/534 (0.4%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
CORONARY OCCLUSION | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
DECOMPENSATED HEART FAILURE | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 2/501 (0.4%) | |||||
DECOMPENSATION CARDIAC | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 2/501 (0.4%) | |||||
END STAGE CARDIAC FAILURE | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 2/423 (0.5%) | 0/501 (0%) | |||||
HEART FAILURE | 11/602 (1.8%) | 6/534 (1.1%) | 1/76 (1.3%) | 3/423 (0.7%) | 2/501 (0.4%) | |||||
INSUFFICIENCY CARDIAC | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
ISCHEMIC CARDIOMYOPATHY | 1/602 (0.2%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
LEFT VENTRICULAR FAILURE | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
LOW CARDIAC OUTPUT SYNDROME | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
MALIGNANT VENTRICULAR ARRHYTHMIAS | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
MITRAL VALVE DISEASE | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
MYOCARDIAL INFARCTION | 2/602 (0.3%) | 3/534 (0.6%) | 0/76 (0%) | 2/423 (0.5%) | 2/501 (0.4%) | |||||
OTHER CARDIAC | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
PAROXYSMAL ATRIAL FIBRILLATION | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
PERICARDIAL EFFUSION | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 2/501 (0.4%) | |||||
PULSELESS ELECTRICAL ACTIVITY | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
SUSTAINED VENTRICULAR TACHYCARDIA | 0/602 (0%) | 0/534 (0%) | 1/76 (1.3%) | 0/423 (0%) | 0/501 (0%) | |||||
SVT | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
TACHYCARDIA | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
UNSTABLE ANGINA | 2/602 (0.3%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
VENTRICULAR ARRHYTHMIA | 2/602 (0.3%) | 4/534 (0.7%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
VENTRICULAR FIBRILLATION | 6/602 (1%) | 3/534 (0.6%) | 2/76 (2.6%) | 0/423 (0%) | 1/501 (0.2%) | |||||
VENTRICULAR TACHYCARDIA | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 2/501 (0.4%) | |||||
Ear and labyrinth disorders | ||||||||||
VERTIGO | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Endocrine disorders | ||||||||||
HYPERTHYROIDISM | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Gastrointestinal disorders | ||||||||||
ASCITES | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
BOWEL ISCHEMIA | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
DIARRHEA | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
GASTRIC ULCER PERFORATED | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
GASTROINTESTINAL NECROSIS | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
UPPER GASTROINTESTINAL HEMORRHAGE | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
VOMITING | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
General disorders | ||||||||||
DEVICE LEAD ISSUE | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
EDEMA | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
HERNIA | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
MULTI ORGAN FAILURE | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
MULTIORGAN FAILURE | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
MULTIPLE ORGAN FAILURE | 0/602 (0%) | 0/534 (0%) | 1/76 (1.3%) | 0/423 (0%) | 0/501 (0%) | |||||
SIRS | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
Hepatobiliary disorders | ||||||||||
CARDIAC CIRRHOSIS | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
GALLSTONES | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
HEPATIC INSUFFICIENCY | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
HEPATOMEGALY | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
JAUNDICE | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Infections and infestations | ||||||||||
ABSCESS | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
BACTEREMIA | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
BRONCHITIS | 2/602 (0.3%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
CMV INFECTION | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
CYSTITIS | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
IMPLANT SITE INFECTION | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
INFECTED SKIN ULCER | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
INFECTION | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 2/501 (0.4%) | |||||
MEDIASTINITIS | 0/602 (0%) | 4/534 (0.7%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
NECROTIZING FASCIITIS | 1/602 (0.2%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
PNEUMONIA | 1/602 (0.2%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
SEPSIS | 1/602 (0.2%) | 1/534 (0.2%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
SEPTIC SHOCK | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
Injury, poisoning and procedural complications | ||||||||||
CHRONIC SUBDURAL HAEMATOMA | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
POSTOPERATIVE HEMORRHAGE | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
POSTPERICARDIOTOMY SYNDROME | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
STERNAL DEHISCENCE | 0/602 (0%) | 2/534 (0.4%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Investigations | ||||||||||
BUN INCREASED | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
CREATININE INCREASED | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Metabolism and nutrition disorders | ||||||||||
GOUT | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
HYPERKALEMIA | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
HYPOKALEMIA | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
HYPOVOLEMIA | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
VOLUME OVERLOAD | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Musculoskeletal and connective tissue disorders | ||||||||||
MYOPATHY | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
SCLERODERMA | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
BRAIN TUMOR | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
CANCER OF LUNG | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
COLON CANCER | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
LUNG CANCER METASTATIC | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
MESOTHELIOMA MALIGNANT | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
MYELODYSPLASTIC SYNDROME | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
SQUAMOUS CELL CARCINOMA | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Nervous system disorders | ||||||||||
ALS | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
ANOXIC ENCEPHALOPATHY | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
EMBOLIC CEREBRAL INFARCTION | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
HEMORRHAGE BRAIN | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
LOSS OF CONSCIOUSNESS | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
STROKE | 17/602 (2.8%) | 16/534 (3%) | 2/76 (2.6%) | 9/423 (2.1%) | 10/501 (2%) | |||||
Psychiatric disorders | ||||||||||
CONFUSION | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Renal and urinary disorders | ||||||||||
ACUTE RENAL FAILURE | 0/602 (0%) | 7/534 (1.3%) | 1/76 (1.3%) | 4/423 (0.9%) | 9/501 (1.8%) | |||||
RENAL FAILURE | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
RENAL INSUFFICIENCY | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
Respiratory, thoracic and mediastinal disorders | ||||||||||
ACUTE PULMONARY EDEMA | 2/602 (0.3%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
ACUTE PULMONARY OEDEMA | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
ACUTE RESPIRATORY INSUFFICIENCY | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
ASPIRATION PNEUMONIA | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
DYSPNEA | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
EDEMA PULMONARY | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
EPISTAXIS | 0/602 (0%) | 0/534 (0%) | 1/76 (1.3%) | 0/423 (0%) | 0/501 (0%) | |||||
MEDIASTINAL HEMORRHAGE | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
PLEURAL EFFUSION | 1/602 (0.2%) | 2/534 (0.4%) | 0/76 (0%) | 0/423 (0%) | 2/501 (0.4%) | |||||
PULMONARY ARTERY THROMBOSIS | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
PULMONARY EDEMA | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
PULMONARY EMBOLISM | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
PULMONARY EMBOLUS | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 1/423 (0.2%) | 1/501 (0.2%) | |||||
PULMONARY THROMBOEMBOLISM | 1/602 (0.2%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
RESPIRATORY FAILURE | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
RESPIRATORY INSUFFICIENCY | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
SHORTNESS OF BREATH | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
Skin and subcutaneous tissue disorders | ||||||||||
ANGIOEDEMA | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
NECROSIS SKIN | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
SKIN TROPHIC ULCER | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Surgical and medical procedures | ||||||||||
HOSPITALIZATION NOS | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Vascular disorders | ||||||||||
AORTIC RUPTURE | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
ARTERIAL EMBOLISM (LIMBS) | 4/602 (0.7%) | 3/534 (0.6%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
CLAUDICATION | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
HAEMODYNAMIC INSTABILITY | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 1/501 (0.2%) | |||||
HEMODYNAMIC INSTABILITY | 1/602 (0.2%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
HYPOTENSION | 0/602 (0%) | 0/534 (0%) | 0/76 (0%) | 1/423 (0.2%) | 0/501 (0%) | |||||
LOW BLOOD PRESSURE | 2/602 (0.3%) | 0/534 (0%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
PERIPHERAL VASCULAR DISEASE | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
SUPERFICIAL PHLEBOTHROMBOSIS | 0/602 (0%) | 1/534 (0.2%) | 0/76 (0%) | 0/423 (0%) | 0/501 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
H01: Medication | H01: Medication + CABG | H01 & H02: Medication+CABG | H02: Medication+CABG | H02: Medication+CABG+SVR | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The agreement is that all publications need to be reviewed and approved by the Policy and Publication Committee and the Sponsor prior to publication.
Results Point of Contact
Name/Title | Dr. Eric Velazquez |
---|---|
Organization | Duke University Health System |
Phone | 919-668-8700 |
velaz002@mc.duke.edu |
- Pro00018940
- U01HL069009
- U01HL069010
- U01HL069011
- U01HL069012
- U01HL069013
- U01HL069015
- U01HL072683
- R01HL105853
- Pro00010463