A Randomized Comparison of Long-term Clinical , Neurocognitive, Angiographical and Health-costs, After Stenting Versus Off-pump Coronary Bypass Surgery in Patients With Symptomatic Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
The randomized comparison of two strategies in coronary revascularization: bypass surgery without the use of a heart lung machine and coronary stenting procedure.
The comparison comprised the occurrence of cardiac adverse events after the procedure. In addition, costs, cognitive outcomes and angiography were assessed.
详细描述
Coronary artery bypass surgery with use of the heart lung machine (on-pump surgery), is associated with the risk of peri-operative complications such as death, stroke, myocardial infarction, neurocognitive decline, and extended hospitalization. Bypass surgery on the beating heart without the use of the heart lung machine (off-pump surgery) has been reintroduced in clinical practice in order to reduce these complications. The Octopus cardiac wall stabilizer, developed at the UMC Utrecht, facilitates the safe construction of the grafts during the off-pump procedure. The expected advantages of off-pump surgery e.g. less-invasiveness, complete arterial revascularization, faster recovery and lower costs were the basis for the Octostent trial. We hypothesized that the off-pump surgical technique might offer an alternative for angioplasty with bare-metal stent-implantation.
The current study was designed as a randomized controlled multicenter trial comparing two strategies.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with coronary artery disease referred for PCI in which both Off Pump Coronary Bypass surgery and PCI were deemed technically feasible
排除标准
- •a history of CABG or stenting
- •emergency or concomitant major surgery
- •Q-wave myocardial infarction in the last six weeks
- •inability to give informed consent
研究组 & 干预措施
Off Pump Coronary Artery Bypass Surgery
干预措施: Coronary Revascularization (Procedure)
Percutaneous Coronary Intervention
干预措施: Coronary Revascularization (Procedure)
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: 7.5 years
次要结局
- Quality of Life(7.5 years)
- Neurocognitive outcome(7.5 years)
- Cost effectiveness(7.5 years)
- Angiographical patency of revascularization(7.5 years)