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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT00023595
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
2,136
1
4
166
12.9

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
  • Procedure: CABG surgery plus MED
  • Drug: Active Medication Alone
  • Procedure: CABG plus MED and SVR
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

Study Type:
Interventional
Actual Enrollment :
2136 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Surgical Treatment for Ischemic Heart Failure (STICH)
Study Start Date :
Jan 1, 2002
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

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:
  • Standard medications for management of CAD and heart failure
  • 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

    1. H01: All Cause Mortality [5 years post randomization]

    2. H01: All Cause Mortality [10 years post randomization]

    3. H02: All-cause Mortality or Cardiovascular Hospitalization [5 years post randomization]

    Secondary Outcome Measures

    1. 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]

    2. 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]

    3. H01: Mortality or Cardiovascular Hospitalization [up to 5 years post randomization]

    4. H01: Mortality or Cardiovascular Hospitalization [up to 10 years post randomization]

    5. H02: All-cause Mortality [up to 5 years]

    6. H01: All-cause Mortality Within 30 Days After Randomization [30 days post randomization]

    7. H02: All-cause Mortality Within 30 Days After Randomization [30 days post randomization]

    8. H01: All-cause Mortality or Heart-failure Hospitalization [5 years post randomization]

    9. H02: All-cause Mortality or Heart-failure Hospitalization [5 years post randomization]

    10. H01: All-cause Mortality or Heart-failure Hospitalization [10 years post randomization]

    11. H01: Heart Failure Hospitalization [5 years post randomization]

    12. H02: Heart Failure Hospitalization [5 years post randomization]

    13. H01: Heart Failure Hospitalization [10 years post randomization]

    14. H01: Cardiac Procedure: Heart Transplant [5 years post randomization]

    15. H02: Cardiac Procedure: Heart Transplant [5 years post randomization]

    16. H01: Cardiac Procedure: Heart Transplant [10 years post randomization]

    17. H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [5 years post randomization]

    18. H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [5 years post randomization]

    19. H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [10 years post randomization]

    20. H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [5 years post randomization]

    21. H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [5 years post randomization]

    22. H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [10 years post randomization]

    23. H01: Stroke [5 years post randomization]

    24. H01: Stroke [10 years post randomization]

    25. H02: Stroke [5 years post randomization]

    26. 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.

    27. 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.

    28. 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.

    29. H01: All-cause Mortality, Heart Transplant or LVAD [5 years post randomization]

      LVAD=Left Ventricular Assist Device

    30. H02: All-cause Mortality, Heart Transplant or LVAD [5 years post randomization]

    31. H01: All-cause Mortality, Heart Transplant or LVAD [10 years post randomization]

      LVAD=Left Ventricular Assist Device

    32. H01: All-cause (Unplanned and Elective) Hospitalization [5 years post randomization]

    33. H02: All-cause (Unplanned and Elective) Hospitalization [5 years post randomization]

    34. H01: All-cause (Unplanned and Elective) Hospitalization [10 years post randomization]

    35. H01: 6 Minute Walk Distance [From randomization to 24 month follow-up]

    36. H02: 6 Minute Walk Distance [From randomization to 24 month follow-up]

    37. 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

    38. 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

    39. 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

    40. 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

    41. 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.

    42. 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.

    43. 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.

    44. 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.

    45. 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

    46. 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

    47. 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.)

    48. 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.)

    49. 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.)

    50. 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.)

    51. 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.)

    52. 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.)

    53. 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.)

    54. 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.)

    55. 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.)

    56. 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.)

    57. 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.

    58. 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.

    59. 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.

    60. 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.

    61. 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. .

    62. 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.

    63. 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. .

    64. 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.

    65. 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. .

    66. 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.

    67. 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.

    68. 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.

    69. 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. .

    70. 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.

    71. 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. .

    72. 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.

    73. 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. .

    74. 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.

    75. 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. .

    76. 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.

    77. 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. .

    78. 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.

    79. 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. .

    80. 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.

    81. 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. .

    82. 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.

    83. 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. .

    84. 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.

    85. 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. .

    86. 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.

    87. 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. .

    88. 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.)

    89. 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. .

    90. 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.

    91. 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. .

    92. 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.

    93. 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. .

    94. 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.

    95. 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. .

    96. 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.

    97. H01: Cost of Care [index hospital admission]

      Hospital costs and physician fees for US patients

    98. H02: Cost of Care [index hospital admission]

      Hospital costs and physician fees for US patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated single photon emission computed tomography (SPECT) studies

    • Coronary anatomy suitable for revascularization

    Exclusion Criteria:
    • Failure to provide informed consent.

    • Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement.

    • Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.

    • Plan for percutaneous intervention of CAD.

    • Recent acute MI judged to be an important cause of left ventricular dysfunction.

    • History of more than 1 prior coronary bypass operation.

    • Noncardiac illness with a life expectancy of less than 3 years.

    • Noncardiac illness imposing substantial operative mortality.

    • Conditions/circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).

    • Previous heart, kidney, liver, or lung transplantation.

    • Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.

    MED Therapy Eligibility Criteria

    • Absence of left main CAD as defined by an intraluminal stenosis of 50% or greater.

    • Absence of CCS III angina or greater (angina markedly limiting ordinary activity).

    SVR Eligibility Criterion

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

    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

    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT00023595
    Other Study ID Numbers:
    • Pro00018940
    • U01HL069009
    • U01HL069010
    • U01HL069011
    • U01HL069012
    • U01HL069013
    • U01HL069015
    • U01HL072683
    • R01HL105853
    • Pro00010463
    First Posted:
    Sep 11, 2001
    Last Update Posted:
    Sep 19, 2019
    Last Verified:
    Sep 1, 2019

    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

    1. Primary Outcome
    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)
    2. Primary Outcome
    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)
    3. Primary Outcome
    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)
    4. Secondary Outcome
    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)
    5. Secondary Outcome
    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)
    6. Secondary Outcome
    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)
    7. Secondary Outcome
    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)
    8. Secondary Outcome
    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)
    9. Secondary Outcome
    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)
    10. Secondary Outcome
    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)
    11. Secondary Outcome
    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)
    12. Secondary Outcome
    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)
    13. Secondary Outcome
    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)
    14. Secondary Outcome
    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%
    15. Secondary Outcome
    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%
    16. Secondary Outcome
    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%
    17. Secondary Outcome
    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%
    18. Secondary Outcome
    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%
    19. Secondary Outcome
    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%
    20. Secondary Outcome
    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%
    21. Secondary Outcome
    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%
    22. Secondary Outcome
    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%
    23. Secondary Outcome
    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%
    24. Secondary Outcome
    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%
    25. Secondary Outcome
    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%
    26. Secondary Outcome
    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%
    27. Secondary Outcome
    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%
    28. Secondary Outcome
    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%
    29. Secondary Outcome
    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)
    30. Secondary Outcome
    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)
    31. Secondary Outcome
    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)
    32. Secondary Outcome
    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)
    33. Secondary Outcome
    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)
    34. Secondary Outcome
    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)
    35. Secondary Outcome
    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%
    36. Secondary Outcome
    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%
    37. Secondary Outcome
    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%
    38. Secondary Outcome
    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)
    39. Secondary Outcome
    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)
    40. Secondary Outcome
    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)
    41. Secondary Outcome
    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)
    42. Secondary Outcome
    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)
    43. Secondary Outcome
    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)
    44. Secondary Outcome
    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)
    45. Secondary Outcome
    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)
    46. Secondary Outcome
    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)
    47. Secondary Outcome
    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)
    48. Secondary Outcome
    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)
    49. Secondary Outcome
    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)
    50. Secondary Outcome
    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
    51. Secondary Outcome
    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
    52. Secondary Outcome
    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
    53. Secondary Outcome
    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
    54. Secondary Outcome
    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
    55. Secondary Outcome
    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
    56. Secondary Outcome
    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
    57. Secondary Outcome
    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
    58. Secondary Outcome
    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
    59. Secondary Outcome
    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
    60. Secondary Outcome
    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
    61. Secondary Outcome
    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
    62. Secondary Outcome
    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
    63. Secondary Outcome
    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
    64. Secondary Outcome
    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
    65. Secondary Outcome
    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
    66. Secondary Outcome
    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
    67. Secondary Outcome
    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
    68. Secondary Outcome
    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
    69. Secondary Outcome
    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
    70. Secondary Outcome
    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
    71. Secondary Outcome
    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
    72. Secondary Outcome
    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
    73. Secondary Outcome
    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
    74. Secondary Outcome
    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
    75. Secondary Outcome
    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
    76. Secondary Outcome
    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
    77. Secondary Outcome
    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
    78. Secondary Outcome
    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
    79. Secondary Outcome
    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
    80. Secondary Outcome
    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
    81. Secondary Outcome
    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
    82. Secondary Outcome
    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
    83. Secondary Outcome
    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
    84. Secondary Outcome
    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
    85. Secondary Outcome
    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
    86. Secondary Outcome
    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
    87. Secondary Outcome
    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
    88. Secondary Outcome
    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
    89. Secondary Outcome
    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
    90. Secondary Outcome
    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
    91. Secondary Outcome
    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
    92. Secondary Outcome
    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.
    93. Secondary Outcome
    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.
    94. Secondary Outcome
    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
    95. Secondary Outcome
    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
    96. Secondary Outcome
    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
    97. Secondary Outcome
    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
    98. Secondary Outcome
    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
    99. Secondary Outcome
    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
    100. Secondary Outcome
    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
    101. Secondary Outcome
    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

    [Not Specified]

    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
    Email velaz002@mc.duke.edu
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT00023595
    Other Study ID Numbers:
    • Pro00018940
    • U01HL069009
    • U01HL069010
    • U01HL069011
    • U01HL069012
    • U01HL069013
    • U01HL069015
    • U01HL072683
    • R01HL105853
    • Pro00010463
    First Posted:
    Sep 11, 2001
    Last Update Posted:
    Sep 19, 2019
    Last Verified:
    Sep 1, 2019