The HYCORE1 Trial: Hybrid Revascularization Versus Coronary Artery Bypass Grafting in Patients With Multi-vessel Coronary Artery Disease. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,048
- 试验地点
- 3
- 主要终点
- A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization
研究概览
简要总结
Coronary artery disease often necessitates complex interventions like coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) with stents. Hybrid coronary revascularization, a minimally invasive approach, integrates both methods for complete revascularization. This multicenter randomized trial involves 1200 patients, comparing hybrid coronary revascularization to CABG in a 1:1 ratio. Eligible participants have multi-vessel coronary disease and are referred for elective or sub-acute CABG. Inclusion criteria include age 18 or older, significant multi-vessel disease, and potential complete revascularization with both methods. Exclusion criteria include chronic kidney disease, pregnancy, contradiction to dual antiplatelet therapy, recent myocardial infarction, and acute revascularization. The hybrid group undergoes staged revascularization, combining minimally invasive grafting of the left interior mammary artery to the left anterior descending artery with PCI-stenting of remaining lesions. The control group undergoes conventional CABG with sternotomy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, or unplanned hospitalization, while secondary outcomes include periprocedural complications, cardiovascular mortality, hospital-free days within 90 days, angina frequency, and quality of life. Evaluation occurs 12 months after randomization. The trial commences in 2024, with inclusion expected to conclude in 5 years.
详细描述
Background Cardiovascular diseases, mainly coronary artery disease (CAD), are the leading causes of death worldwide. CAD is characterised by the narrowing or blockage of blood flow in the coronary arteries often necessitating complex interventions like coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) with drug-eluting stents. The preferred revascularisation strategy depends on several characteristics, one being the number of diseased vessels. Multi-vessel coronary artery disease (MVD) is defined as stenosis of at least two major coronary arteries.
Over the years, several large trials have concluded that CABG and PCI with newer-generation drug-eluting stents are both associated with improved survival rates compared to medical therapy.
CABG is still regarded as the gold standard for complex multi-vessel disease, with the cornerstone being the in-situ left internal mammary artery (LIMA) anastomosed to the left anterior descending artery (LAD).1 Current guidelines recommend CABG or PCI with equipoise in patients with one-vessel proximal LAD stenosis, two-vessel disease with proximal LAD stenosis, left main disease or three-vessel disease with lower complexity. The LIMA graft, with its excellent patency, has been shown to outperform PCI of the LAD and is in part responsible for the apparent success and survival benefit of CABG.3 However, saphenous vein grafts, the most common graft for non-LAD targets perform rather poorly, with graft failure ranging as high as 43%, 18 months after surgery. PCI with DES, especially with intravascular imaging, is documenting meagre failure rates and may consequently offer better results in non-LAD vessels than CABG with vein grafts does.
Despite its survival benefits, the CABG comes at the cost of a full sternotomy, necessitating longer rehabilitation. Patients may prefer less invasive treatment options if these are feasible and have consistent long-term results. The minimally invasive coronary artery bypass (MIDCAB) procedure was developed as a less invasive method for revascularisation. MIDCAB allows for the grafting of the anterior vessels through a small left anterior thoracotomy without the use of extracorporeal circulation. Thus, ensuring vital revascularisation with a lesser trauma.
Complete revascularisation has been established as the most important factor for survival. Recent data have showed comparable 10-year mortality in patients achieving this goal with either PCI or CABG.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
We intend to blind all possible trial personal. Participants and care providers can not be blinded due to obvious scaring on the patient and the hospital ward (department) that is responsible for patient care.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •≥ 18 years of age
- •Functionally significant MVD, defined as ≥ 70% diameter stenosis by visual estimation or functionally significant stenosis (FFR < 0.80, non-hyperaemic index (iFR) < 0.89) in at least two of the major epicardial vessels or major side branches
- •Patient history reviewed by both cardiac surgeon and cardiologist who in agreement find both CABG and hybrid revascularisation indicated and technically feasible with an expectation of complete revascularisation of all functionally significant stenoses in the LAD and at least one other coronary artery ≥ 2.5mm in diameter or left main bifurcation stenosis with functionally significant stenoses in both the LAD and left circumflex artery.
排除标准
- •Chronic kidney disease with estimated glomerular filtration rate < 20 mL/min/kg
- •Pregnancy
- •Left main stenosis without additional functionally significant stenoses in both the LAD and the LCX
- •Contraindications to the use of dual antiplatelet therapy
- •STEMI within 1 month
- •Indication for acute revascularization
研究组 & 干预措施
Hybrid Group
Complete revascularisation through a combined MIDCAB (LIMA-LAD graft trough a minimal invasive left anterior thoracotomy) and PCI (of all non-LAD stenoses)
干预措施: Hybrid coronary revascularization (Procedure)
CABG Group
Conventional CABG through a sternotomy
干预措施: Conventional revascularization (Procedure)
结局指标
主要结局
A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization
时间窗: 12 months after randomization
A composite outcome of either all-cause mortality, a diagnosis of spontaneous myocardial infarction, a diagnosis of stroke, or any unplanned hospitalization
次要结局
- Hospital free days(90 days after randomization)
- Angina symptoms(12 months after randomization)
- Procedural complications(12 months after randomization)
- Health related quality of life(12 months after randomization)
研究者
Christian Lildal Carranza
Chief Investigator
Rigshospitalet, Denmark