Off-Pump Coronary Artery Bypass Grafting Versus Conventional Coronary Artery Bypass Grafting on Postoperative Mortality and Morbidity, A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 341
- 试验地点
- 2
- 主要终点
- All cause mortality
研究概览
简要总结
There is evidence linking cardiopulmonary bypass to negative side effects when used for coronary artery bypass grafting. Coronary artery bypass grafting can be performed without the use of cardiopulmonary bypass. The purpose of this study is to determine the positive and negative effects of coronary artery bypass grafting with or without the use of cardiopulmonary bypass. The patients will be followed at least one year after surgery.
详细描述
Objectives:
To evaluate the beneficial and harmful effects of off-pump coronary artery bypass grafting (OPCAB) versus conventional coronary artery bypass grafting (CCABG) using a heart- and lung machine in patients with three-vessel coronary artery disease.
Trial population:
Consecutive patients > 54 years of age with three-vessel coronary artery disease with EuroSCORE of 5-16 undergoing elective or sub-acute coronary artery bypass grafting, giving written informed consent, and where randomisation can be accomplished preoperatively. The study will include 330 patients.
Trial design:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known ischemic three vessel heart disease affecting one of the marginal coronary arteries
- •Age > 54 years
- •Scheduled for elective or subacute CABG
- •EuroSCORE > 4 and < 17
- •The patient has signed written informed consent before randomization and surgery.
排除标准
- •Previous heart surgery
- •Ejection fraction < 30 %
- •Unstable preoperative condition, i.e., continuous infusion of inotropics on the day of the operation
- •Patient unable to give informed consent.
结局指标
主要结局
All cause mortality
时间窗: Short and long term
Acute myocardial infarction
Cardiac arrest with successful resuscitation
Low cardiac output syndrome/cardiogenic shock
Stroke
Need for renewed cardiac revascularization procedure
次要结局
- Duration of stay in the hospital
- Quality of life after 3 and 12 month
- Hyper dynamic shock
- Atrial fibrillation during index admission
- Need for pacing > 24 hours
- Renal complications, i.e., increased serum creatinine
- Reoperation for bleeding during index admission
- Pneumonia
- Respiratory insufficiency requiring intubation > 24 hours postoperatively
- Serious adverse events
- Duration of stay in intensive care unit
- Graft patency at one year postoperatively defined by coronary angiography.