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

Cardiovascular Diseases Clinical Trial

— STICH  

Official title:

Surgical Treatment for Ischemic Heart Failure (STICH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023595
• Other study ID #: Pro00018940
• Secondary ID: U01HL069009U01HL
• Status: Completed
• Phase: Phase 3
• Start date: January 2002
• Est. completion date: November 2015

Study information

• Verified date: September 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2136
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• CABG surgery plus MED
CABG plus standard medication management for Coronary Artery Disease

Drug:
• Active Medication Alone
Standard medication for coronary artery disease and heart failure management.

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Velazquez EJ, Lee KL, O'Connor CM, Oh JK, Bonow RO, Pohost GM, Feldman AM, Mark DB, Panza JA, Sopko G, Rouleau JL, Jones RH; STICH Investigators. The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. J Thorac Cardiovasc Surg. 2007 Dec;134(6):1540-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H01: All Cause Mortality		5 years post randomization
Primary	H01: All Cause Mortality		10 years post randomization
Primary	H02: All-cause Mortality or Cardiovascular Hospitalization		5 years post randomization
Secondary	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
Secondary	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
Secondary	H01: Mortality or Cardiovascular Hospitalization		up to 5 years post randomization
Secondary	H01: Mortality or Cardiovascular Hospitalization		up to 10 years post randomization
Secondary	H02: All-cause Mortality		up to 5 years
Secondary	H01: All-cause Mortality Within 30 Days After Randomization		30 days post randomization
Secondary	H02: All-cause Mortality Within 30 Days After Randomization		30 days post randomization
Secondary	H01: All-cause Mortality or Heart-failure Hospitalization		5 years post randomization
Secondary	H02: All-cause Mortality or Heart-failure Hospitalization		5 years post randomization
Secondary	H01: All-cause Mortality or Heart-failure Hospitalization		10 years post randomization
Secondary	H01: Heart Failure Hospitalization		5 years post randomization
Secondary	H02: Heart Failure Hospitalization		5 years post randomization
Secondary	H01: Heart Failure Hospitalization		10 years post randomization
Secondary	H01: Cardiac Procedure: Heart Transplant		5 years post randomization
Secondary	H02: Cardiac Procedure: Heart Transplant		5 years post randomization
Secondary	H01: Cardiac Procedure: Heart Transplant		10 years post randomization
Secondary	H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)		5 years post randomization
Secondary	H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)		5 years post randomization
Secondary	H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)		10 years post randomization
Secondary	H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)		5 years post randomization
Secondary	H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)		5 years post randomization
Secondary	H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)		10 years post randomization
Secondary	H01: Stroke		5 years post randomization
Secondary	H01: Stroke		10 years post randomization
Secondary	H02: Stroke		5 years post randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	H01: All-cause Mortality, Heart Transplant or LVAD	LVAD=Left Ventricular Assist Device	5 years post randomization
Secondary	H02: All-cause Mortality, Heart Transplant or LVAD		5 years post randomization
Secondary	H01: All-cause Mortality, Heart Transplant or LVAD	LVAD=Left Ventricular Assist Device	10 years post randomization
Secondary	H01: All-cause (Unplanned and Elective) Hospitalization		5 years post randomization
Secondary	H02: All-cause (Unplanned and Elective) Hospitalization		5 years post randomization
Secondary	H01: All-cause (Unplanned and Elective) Hospitalization		10 years post randomization
Secondary	H01: 6 Minute Walk Distance		From randomization to 24 month follow-up
Secondary	H02: 6 Minute Walk Distance		From randomization to 24 month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	H01: Cost of Care	Hospital costs and physician fees for US patients	index hospital admission
Secondary	H02: Cost of Care	Hospital costs and physician fees for US patients	index hospital admission

External Links

•   STICH trial website