Efficacy and Safety of One-Step Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for Patients With Multivessel Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac and Cerebrovascular Events (MACCE)
研究概览
简要总结
Coronary revascularization could be accomplished either by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). PCI with drug-eluting stent (DES) implantation is featured by minimal invasive, low complication and rapid rehabilitation. CABG is characterized by improved long-term, event-free survival attributable to the use of left internal mammary artery (LIMA) graft. Hybrid coronary revascularization (HCR) consists of LIMA bypass to left anterior coronary descending artery (LAD) by minimal invasive direct coronary artery bypass (MIDCAB) and PCI of other stenosed coronary arteries with DES implantation. One-step HCR entails LIMA-LAD anastomosis performed through MIDCAB, immediately followed by PCI for non-LAD lesions, sometimes for diagonal branch, in the hybrid operating room. Limited data are available in comparing one-step HCR to PCI alone for the treatment of multivessel coronary artery disease(MVD). The current EAST-HCR study will investigate the efficacy and safety of one-step HCR for patients with MVD, as comparing to PCI 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 Years and older
- •signed the informed consent
- •indicated for revascularization, with possible bypass segment in LAD and amendable lesions by PCI in other vessels
- •anatomy requiring as following: (1) Multivessel CAD involving the LAD (proximal or mid) and/or LM (ostial, mid-shaft or distal) with at least 1 other epicardial coronary artery requiring treatment in LCX or RCA, including: (2) LAD disease, and a major diagonal lesion, either bifurcation or independent in location, with both requiring revascularization (determined by QFR or FFR) (3) LM distal bifurcation lesion (Medina 1,1,1), intended for 2-stent approach if randomized to PCI
- •Heart team discussion after angiogram, with conclusion of suitable candidate for either PCI or HCR
- •Able to tolerate and no plans to interrupt dual anti-platelet therapy for 3~12 months
- •Willing to comply with 2-year clinical follow-up
排除标准
- •Previous cardiac or thoracic surgery
- •Previous PCI of the LM and/or LAD within 12 months
- •Totally occluded left main vessel
- •Cardiogenic shock or LVEF <30%
- •Previous STEMI within 30-day prior to randomization
- •Concomitant vascular or other cardiac disease with plan of surgical treatment
- •Indication for chronic oral anticoagulation therapy
- •Previous stroke history within 6-month prior to randomization
- •Survival expectation less than 3 years due to non-cardiac illness
- •Allergy or hypersensitivity to any of the study drugs or devices used in the trial
- •Enrolled in additional clinical study
- •Informed consent not available or noncompliance with follow-up
结局指标
主要结局
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
时间窗: 2 years
the occurrence of MACCE at 2 years' clinical follow-up, including all-cause death, myocardial infarction, stroke, and repeated revascularization
次要结局
- Rate of complete revascularization at index hospitalization(2 years)
- Hospital duration (day)(up yo 2 years)
- Stent thrombosis event(2 years)
- Bleeding events(2 years)