Prospective, Single-center, Randomized Trial, Intended to Compare Three Revascularization Strategies in Patients With Multi-vessel Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Residual ischemia
研究概览
简要总结
Minimally invasive revascularization of the left anterior descending artery followed by stent implantation versus percutaneous coronary intervention or coronary artery bypass in patients with multi-vessel coronary disease
详细描述
Prospective, single-center, randomized trial, intended to compare three revascularization strategies in patients with multi-vessel coronary artery disease:
- Hybrid approach (Minimally invasive off-pump revascularization of the left anterior descending artery (LAD) with left internal mammary artery (LIMA) bypass followed by consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with drug eluting stents (DES) (Hybrid group, n=50)
- Multi-vessel PCI with DES (MV-PCI group, n=50)
- Coronary artery bypass graft (CABG) treatment (CABG group, n=50)
PCI in Hybrid and MV-PCI group will be performed with the same 2nd generation clinically proven DES (Xience V, Xience Prime).
Study objective Compare three different revascularization strategies in patients with multi-vessel coronary disease
The endpoints:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multi-vessel coronary artery disease with ≥ 70% and <96% artery stenosis (according to QCA)
- •I-IV CCS functional class of angina
- •Asymptomatic patients with stress-test documented ischemia.
- •Patients at 1 month after acute myocardial infarction
- •Ability to perform either of revascularization methods (Hybrid, MVD-PCI, CABG).
- •Consensus on the treatment strategy between the members of the working group, including cardiologist, cardiac surgeon and interventional specialist.
- •Patients must have signed an informed consent.
排除标准
- •Acute coronary syndrome.
- •Previous CABG.
- •Previous stent thrombosis.
- •Severe comorbidity with high procedural risk for either of the studied strategies.
- •Severe peripheral artery disease.
- •Other serious diseases limiting life expectancy (e.g. oncology)
- •Inability for long-term follow-up.
- •Participation in other clinical trials.
- •Inability to take dual antithrombotic therapy.
- •Angiographic exclusion criteria
- •Critical stenosis (>95%) in RCA,LAD, CX or Intermediate artery, feasible for revascularization.
- •Stenosis of left main ≥ 50%.
- •Coronary artery occlusion of the major vessel.
- •Single vessel disease.
- •Need for emergency revascularization (ACS).
研究组 & 干预措施
Hybrid group
Hybrid approach (Minimally invasive off-pump revascularization of the left anterior descending artery (LAD) with the left internal mammary artery (LIMA) bypass followed by consecutive percutaneous coronary intervention (PCI) in the rest of the arteries with drug eluting stents (DES) (Hybrid group, n=50)
干预措施: Hybrid (MIDCAB+PCI) (Procedure)
PCI
Multi-vessel PCI with DES (MV-PCI group, n=50)
干预措施: PCI (Procedure)
CABG
Coronary artery bypass graft (CABG) treatment (CABG group, n=50)
干预措施: CABG (Procedure)
结局指标
主要结局
Residual ischemia
时间窗: 6 - to 18-month follow-up
≥5% residual ischemia by single photon emission computed tomography (SPECT)
次要结局
- MACCE(up to 5 years)
- Procedural success(up to discharge from the hospital)
- Procedural and post-procedural blood loss and number of transfusions(up to discharge from the hospital)
- Recovery time(up to discharge from the hospital)
- Restenosis(6- to 18-month follow-up)
- Target vessel/graft failure(6- to 18-month follow-up)
研究者
Dr. Vladimir Ganyukov
Hybrid minimally invasive and Interventional coronary revascularization in patients with Multi-vessel coronary artery disease versus complete Endovascular Revascularisation or coronary Artery bypass graft (treatment strategies).
Russian Academy of Medical Sciences