ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 411
- 试验地点
- 8
- 主要终点
- Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following)
研究概览
简要总结
Compare completeness and modality of revascularization, operative and postoperative results and 1 year clinical outcomes in unselected high risk patients referred for primary coronary artery bypass surgery. Patients will be randomized to undergo off-pump coronary artery bypass graft (OPCAB) or coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB).
详细描述
The initial application of off-pump coronary artery bypass in the early nineties was mainly directed to highly selected and relatively low risk surgical patients. Since then there has been a growing body of evidence suggesting many potential advantages of the OPCAB technique over the conventional cardiopulmonary bypass (CPB) technique in different groups of high-risk patients.
On-off study is a multicentre, prospective, randomized, parallel, trial.Patients indicated for elective or urgent isolated coronary artery bypass graft with additive European System for Cardiac Operative Risk Evaluation ≥ 6 were enrolled. Patients in cardiogenic shock were excluded. Patients were randomly assigned either to coronary artery bypass surgery with cardiopulmonary bypass (ON arm) or to off-pump coronary artery bypass graft (OFF arm). The composite primary end point included operative mortality, myocardial infarction, stroke, renal failure, re-operation for bleeding and adult respiratory distress syndrome, within 30 days after surgery. The total planned sample size was 693 patients; the actual number of enrolled patients was 411,according to the results of the interim analysis scheduled at 400 enrollments (alfa-spending=0.029, Pocock method).
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
- •Pts candidate to a myocardial revascularization for any patter of coronary artery disease, ventricular dysfunction or any other co-morbidity
- •EUROSCORE ≥ 6
- •Pts who signed the Informed Consent
- •Age ≥ 18 years
排除标准
- •Patients in cardiogenic shock requiring emergency surgery or preoperative intra-aortic balloon pump
- •Patients requiring additional surgical procedures
- •Porcelain Aorta
- •Lack of informed consent
研究组 & 干预措施
Off-pump bypass surgery
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
干预措施: Off-pump bypass surgery (Procedure)
On-pump bypass surgery
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
干预措施: On-pump bypass surgery (Procedure)
结局指标
主要结局
Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following)
时间窗: 30 days
Number of patients with one or more of the following: * Operative Mortality * Myocardial Infarction * Postoperative neurological complications * Renal failure * ARDS (Acute Respiratory Distress Syndrome) * Bleeding
次要结局
- Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following)(30 days)