Surgical Treatment for Ischemic Heart Failure (STICH)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,136
- 试验地点
- 1
- 主要终点
- H02: All-cause Mortality or Cardiovascular Hospitalization
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
H01: Medication
Medical therapy alone to treat Coronary Artery Disease
干预措施: Active Medication Alone (Drug)
H01: Medication + CABG
Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease
干预措施: CABG surgery plus MED (Procedure)
H02: Medication+CABG
Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease
干预措施: CABG surgery plus MED (Procedure)
H02: Medication+CABG+SVR
CABG plus Medication and Surgical ventricular reconstruction (SVR)
干预措施: CABG plus MED and SVR (Procedure)
结局指标
主要结局
H02: All-cause Mortality or Cardiovascular Hospitalization
时间窗: 5 years post randomization
H01: All Cause Mortality
时间窗: 10 years post randomization
次要结局
- H02: All-cause Mortality(up to 5 years)
- H02: All-cause Mortality Within 30 Days After Randomization(30 days post randomization)
- H01: All-cause Mortality or Revascularization (CABG or PCI)(10 years post randomization)
- H02: LVEF by ECHO Core Lab During Follow-up(From randomization to 24 months follow-up)
- H01: Mortality or Cardiovascular Hospitalization(up to 10 years post randomization)
- H01: All-cause Mortality or Heart-failure Hospitalization(10 years post randomization)
- H01: Heart Failure Hospitalization(10 years post randomization)
- H01: All-cause Mortality, Heart Transplant or LVAD(10 years post randomization)
- H01: 6 Minute Walk Distance(From randomization to 24 month follow-up)
- H02: Heart Failure Hospitalization(5 years post randomization)
- H01: Stroke(10 years post randomization)
- H02: Cost of Care(index hospital admission)
- 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: All-cause Mortality Within 30 Days After Randomization(30 days post randomization)
- H01: Cardiac Procedure: Heart Transplant(10 years post randomization)
- H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)(10 years post randomization)
- H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)(5 years post randomization)
- H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)(10 years post randomization)
- H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)(5 years post randomization)
- H02: All-cause Mortality or Heart-failure Hospitalization(5 years post randomization)
- H02: Cardiac Procedure: Heart Transplant(5 years post randomization)
- H02: All-cause Mortality or Revascularization (CABG or PCI)(5 years post randomization)
- H01: All-cause (Unplanned and Elective) Hospitalization(10 years post randomization)
- H02: SF-36 Role Emotional Subscale(From enrollment to 3-year follow-up)
- H01:SF-36 Social Functioning Subscale(From enrollment to 3-year follow-up)
- H02: Stroke(5 years post randomization)
- H02: All-cause Mortality, Heart Transplant or LVAD(5 years post randomization)
- H02: All-cause (Unplanned and Elective) Hospitalization(5 years post randomization)
- H02: 6 Minute Walk Distance(From randomization to 24 month follow-up)
- H01: Exercise Duration(From randomization to 24 months follow-up)
- H02: B-type Natriuretic Peptide (BNP)(From randomization to 24 months follow-up)
- H01: SF-36 Mental Health Subscale(From enrollment to 3-year follow-up)
- H02: SF-36 Social Functioning Subscale(From enrollment to 3-year follow-up)
- H02: SF-12 Mental Component Summary (MCS) Scale(From enrollment to 3-year follow-up)
- H02: KCCQ Symptom Frequency(From enrollment to 3-year follow-up)
- H01: LVEF by ECHO Core Lab During Follow-up(From randomization to 24 months follow-up)
- H01: LVEF by RN Core Lab During Follow-up(From randomization to 24 months follow-up)
- H02: SF-36 Role Physical Subscale(From enrollment to 3-year follow-up)
- H01:SF-36 Role Emotional Subscale(From enrollment to 3-year follow-up)
- H02: SF-36 Vitality Subscale(From enrollment to 3-year follow-up)
- H02: Exercise Duration(From randomization to 24 months follow-up)
- H02: LVEF by RN Core Lab During Follow-up(From randomization to 24 months follow-up)
- H02: SF-36 Mental Health Subscale(From enrollment to 3-year follow-up)
- H01:SF-36 Role Physical Subscale(From enrollment to 3-year follow-up)
- H01: KCCQ Physical Limitation Scale(From enrollment to 3-year follow-up)
- H01: KCCQ Symptom Stability(From enrollment to 3-year follow-up)
- H01: LVEF by CMR Core Lab During Follow-up(From randomization to 24 months follow-up)
- H02: LVEF by CMR Core Lab During Follow-up(From randomization to 24 months follow-up)
- H01: B-type Natriuretic Peptide (BNP)(From randomization to 24 months follow-up)
- H01:SF-36 Vitality Subscale(From enrollment to 3-year follow-up)
- H01: SF-12 Mental Component Summary (MCS) Scale(From enrollment to 3-year follow-up)
- H01: KCCQ Symptom Burden(From enrollment to 3-year follow-up)
- H02: KCCQ Total Symptoms(From enrollment to 3-year follow-up)
- H01: KCCQ Overall Summary Score(From enrollment to 3-year follow-up)
- H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale(From enrollment to 3-year follow-up)
- H01:SF-12 Physical Component Summary (PCS) Scale(From enrollment to 3-year follow-up)
- H02: SF-12 Physical Component Summary (PCS) Scale(From enrollment to 3-year follow-up)
- H02: KCCQ Physical Limitation Scale(From enrollment to 3-year follow-up)
- H02: KCCQ Symptom Stability(From enrollment to 3-year follow-up)
- H01: KCCQ Symptom Frequency(From enrollment to 3-year follow-up)
- H01: KCCQ Total Symptoms(From enrollment to 3-year follow-up)
- H01: KCCQ Quality-of-Life Scale(From enrollment to 3-year follow-up)
- H01: KCCQ Clinical Summary Score(From enrollment to 3-year follow-up)
- H02: KCCQ Clinical Summary Score(From enrollment to 3-year follow-up)
- H02: KCCQ Overall Summary Score(From enrollment to 3-year follow-up)
- H02: KCCQ Quality-of-Life Scale(From enrollment to 3-year follow-up)
- H01: KCCQ Social Limitation(From enrollment to 3-year follow-up)
- H02: KCCQ Social Limitation(From enrollment to 3-year follow-up)
- H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale(From enrollment to 3-year follow-up)
- H01: EQ-5D Health Status Index Score(From enrollment to 3-year follow-up)
- H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale(From enrollment to 3-year follow-up)
- H01: General Health Rating Scale(From enrollment to 3-year follow-up)
- H02: KCCQ Symptom Burden(From enrollment to 3-year follow-up)
- H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale(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(From enrollment to 3-year follow-up)
- H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale(From enrollment to 3-year follow-up)
- H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale(From enrollment to 3-year follow-up)
- H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale(From enrollment to 3-year follow-up)
- H01: EQ-5D Visual Analog Scale(From enrollment to 3-year follow-up)
- H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale(From enrollment to 3-year follow-up)
- H02: General Health Rating Scale(From enrollment to 3-year follow-up)
- H01: Cost of Care(index hospital admission)
- H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale(From enrollment to 3-year follow-up)
- H02: EQ-5D Visual Analog Scale(From enrollment to 3-year follow-up)
- H02: EQ-5D Health Status Index Score(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(From enrollment to 3-year follow-up)
- H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale(From enrollment to 3-year follow-up)