CABG or PCI in Patients With Ischemic Cardiomyopathy - A Randomized Registry Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 470
- 试验地点
- 2
- 主要终点
- Major adverse cardiac event
研究概览
简要总结
The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) <40%) and multi-vessel coronary artery disease.
详细描述
Short background/ Rationale/Aim:
CABG has been shown to prolong survival in patients with reduced left ventricular (LV) function and multi-vessel coronary artery disease and "CABG is recommended as the first revascularization strategy choice in patients with multi-vessel disease and acceptable surgical risk". However, a major concern with CABG is the early risk of complications, including death and stroke. Although PCI has lower rates of peri-procedural complications than CABG in patients without heart failure (HF), this has not been confirmed in patients with HF. The lack of contemporary data comparing CABG and PCI in HF leaves clinicians with no guidance as to which option to choose, and a robust trial is therefore necessary. The STICH-SWEDEHEART trial will compare PCI vs CABG for revascularization of patients with HF and LV systolic dysfunction (LV ejection fraction (LVEF) < 40%) and multi-vessel coronary artery disease.
Study objective:
To test whether PCI is non-inferior to CABG for revascularization of patients with ischemic heart failure.
Study design:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Symptomatic HF defined as NYHA HF class II-IV within 1 month of enrolment
- •LVEF ≤ 40% quantified by either echocardiography or gated SPECT ventriculography, or magnetic resonance (MR) or any other recognized assessment of LVEF
- •Meaningful amount of myocardium at risk because of CAD (BCIS myocardial jeopardy score ≥ 6 on a recent (> 6 months) coronary angiogram);
- •Heart team believes that a meaningful revascularization can be achieved by both PCI or CABG, with complete revascularization defined as residual ischemia in <10% of the left ventricle
- •Heart team agrees that guideline directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or without acute coronary syndrome (ACS)) requiring revascularization before discharge, GDMT needs to be initiated, when possible, in-hospital before randomization, with the expectation that it will be titrated to maximally tolerated doses after revascularization
- •Written informed consent obtained
排除标准
- •Previous randomization in the study
- •Decompensated heart failure requiring inotropic /adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization
- •Recent (<1 month) type 1 myocardial infarction
- •Recent PCI (<3 months)
- •Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) requiring surgical repair/replacement
- •Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy
- •Expected survival less than 3 years due to non-cardiac illness
- •Circumstances likely to lead to poor treatment compliance
- •Individuals for whom record in public health databases is not accessible (non-eligibility to public health system, parallel healthcare systems
- •Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception
结局指标
主要结局
Major adverse cardiac event
时间窗: 3 years
The occurrence of the composite of death, stroke, non-procedural myocardial infarction or heart failure hospitalization
次要结局
- The occurrence of death(3 years)
- The occurrence of heart failure hospitalizations(3 year)
- The occurrence of non-procedural myocardial infarction,(3 year)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) score(1 year)
- The occurrence of stroke(3 year)