A Randomized Controlled Trial to Investigate the Ideal Sequence of Hybrid Coronary Revascularization with Endoscopic Coronary Revascularization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- 30-day net adverse clinical event (NACE)
研究概览
简要总结
Hybrid coronary revascularization (HCR), a combination of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI), has emerged as an alternative treatment for multivessel coronary artery disease patients. However, the ideal sequence (PCI or CABG) is unclear.
The overall aim of this study is to investigate the best sequence within hybrid coronary revascularization using endoscopic coronary bypass grafting (i.e., first CABG then PCI versus first PCI then CABG)
详细描述
Hybrid coronary revascularization (HCR) is an emerging approach for multivessel coronary artery disease (MVD) which combines the excellent long-term outcomes of surgery with the early recovery and reduced short-term complications of percutaneous coronary intervention (PCI). However, the best sequence within hybrid coronary revascularization remains unclear. When CABG is performed first (standard HCR), incomplete revascularization can cause acute coronary events in the interim period. On the other hand, when PCI is performed first (reverse HCR), bleeding risks may be higher since CABG should be performed on uninterrupted dual anti-platelet therapy (DAPT). The use of minimally invasive surgery techniques is associated with reduced bleeding because of the less surgical trauma and may offer the opportunity to perform reverse HCR due to the possibility to reduce the risk of bleeding.
The overall aim of this study is to investigate the best sequence within hybrid coronary revascularization using endoscopic coronary bypass grafting (i.e., first CABG then PCI versus first PCI then CABG, figure 1)
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multivessel coronary disease, defined as ≥ 50% diameter stenosis by visual estimation in 2 or more of the three major epicardial vessels or major side branches, with at least one or more one stenosis amenable to revascularization with PCI, if the patient cannot be full revascularized by surgery for a specific reason as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if the left anterior descending artery (LAD) and left circumflex have ≥50% stenosis.
- •Age 18-85
- •Willing and able to provide informed, written consent
排除标准
- •Requirement for other cardiac or non-cardiac surgical procedures (e.g., valve replacement, carotid revascularization)
- •Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support at the time of randomisation
- •Left main coronary artery disease
- •Contraindication for dual antiplatelet therapy
- •ST-Elevation Myocardial Infarction (STEMI)
- •Previous cardiac surgery
- •Participation in other interventional clinical trials
- •Recent coronary intervention (PCI)
- •Ongoing high risk non-ST-segment elevation acute coronary syndrome (ACS)
- •Life expectancy < 1 year
- •Active bleeding more or equal to BARC 2 at time of randomisation
- •Requiring renal replacement therapy
- •Undergoing evaluation for organ transplantation
研究组 & 干预措施
Reverse hybrid coronary revascularization (HCR)
Patients will undergo reverse hybrid coronary revascularization. Moreover, quality of life is assessed at baseline, 14 days, 30 days, 90 days, 6 months and 1 year.
干预措施: Reverse hybrid coronary revascularization (Procedure)
Standard hybrid coronary revascularization (HCR)
Patients will undergo standard hybrid coronary revascularization. Moreover, quality of life is assessed at baseline, 14 days, 30 days, 90 days, 6 months and 1 year.
干预措施: Standard hybrid coronary revascularization (Procedure)
结局指标
主要结局
30-day net adverse clinical event (NACE)
时间窗: From the first procedure until 30 days after the second procedure.
NACE consists of major adverse cardiac and cerebrovascular events (MACCE) and major bleeding unrelated to CABG (Bleeding Academic Research Consortium (BARC) type 3 and 5) MACCE consists of: * Death from any cause * Myocardial infarction * Stroke * Target lesion revascularisation
次要结局
- Key secondary outcome: 30-day major adverse cardiac and cerebrovascular events (MACCE)(From the first procedure until 30 days after the second procedure)
- Stent thrombosis(From the first procedure until one year after the second procedure)
- Graft failure(From the first procedure until one year after the second procedure)
- Key secondary outcome: 30-day major or clinically relevant non-major bleeding (BARC type 2, 3, 4, 5)(From the first procedure until 30 days after the second procedure)
- Key secondary outcome: One-year net adverse clinical event (NACE)(From the first procedure until one year after the second procedure)
- Key secondary outcome: one-year major adverse cardiac and cerebrovascular events (MACCE)(From the first procedure until one year after the second procedure)
- Quality of Life (QoL) using the Short-form 36 (SF-36) questionnaire(14, 30, 90, 180 and 365 days after the second procedure)
- Revascularization(From the first procedure until one year after the second procedure)
- Bleeding(From the first procedure until one year after the second procedure)
- Key secondary outcome: One-year major or clinically relevant non-major bleeding (BARC type 2, 3, 4, 5)(From the first procedure until one year after the second procedure)
- Quality of Life (QoL) using the Seattle Angina Questionnaire short-form (SAQ-7)(14, 30, 90, 180 and 365 days after the second procedure)
- Mortality(From the first procedure until one year after the second procedure)
- Myocardial infarction(From the first procedure until one year after the second procedure)
- Stroke(From the first procedure until one year after the second procedure)
- Quality of Life (QoL) using the Euro Quality of Life 5 dimensions (EQ-5D) questionnaire(14, 30, 90, 180 and 365 days after the second procedure)
- Quality of Life (QoL) using the Rose Dyspnea Scale (RDS)(14, 30, 90, 180 and 365 days after the second procedure)