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

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

Detailed Description
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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.

Official Title
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Surgical Treatment for Ischemic Heart Failure (STICH)

Conditions
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Cardiovascular Diseases, Coronary Disease, Heart Failure, Congestive, Heart Diseases

Intervention / Treatment
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* Procedure: CABG surgery plus MED
* Drug: Active Medication Alone
* Procedure: CABG plus MED and SVR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: H01: Medication<br>Medical therapy alone to treat Coronary Artery Disease | Drug: Active Medication Alone<br>* Standard medication for coronary artery disease and heart failure management.<br>* Other names: Standard medications for management of CAD and heart failure;|
| Active Comparator: H01: Medication + CABG<br>Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease | Procedure: CABG surgery plus MED<br>* CABG plus standard medication management for Coronary Artery Disease<br>|
| Active Comparator: H02: Medication+CABG<br>Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease | Procedure: CABG surgery plus MED<br>* CABG plus standard medication management for Coronary Artery Disease<br>|
| Active Comparator: H02: Medication+CABG+SVR<br>CABG plus Medication and Surgical ventricular reconstruction (SVR) | Procedure: CABG plus MED and SVR<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H01: All Cause Mortality |  | 5 years post randomization | 
| H01: All Cause Mortality |  | 10 years post randomization | 
| H02: All-cause Mortality or Cardiovascular Hospitalization |  | 5 years post randomization | 

Secondary Outcome Measures

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