CABG Off or On Pump Revascularization Study (CORONARY)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,752
- 试验地点
- 90
- 主要终点
- First Co-Primary Outcome
研究概览
简要总结
I. Main Research Question:
- To compare the risks and benefits of Off-pump Coronary artery bypass surgery (CABG) to On-pump CABG and to determine if one is better than the other.
- The purpose of this pilot study is also to see the rate of recruitment with expertise-based randomization across different hospital settings.
II. Small RCT studies and meta-analyses done so far have not been able to conclusively say which of the procedure is better. A large randomized study is required to establish the risks and benefits associated with both the off-pump and on-pump CABG surgical procedures.
III. The study will look at which of the two techniques reduce major risks associated with CABG.
详细描述
Rationale and purpose of the study:
Coronary artery bypass grafting (CABG) surgery prolongs life-expectancy in patients with severe ischemic heart disease, especially those with left main, triple vessel disease or single/double vessel disease with stenosis of the proximal left anterior descending (LAD) artery. The perioperative mortality is about 2% with an additional 5% to 7% suffering complications such as myocardial infarction, stroke, renal failure, etc. The technique of operating on a beating heart (off-pump) for coronary artery bypass grafting surgery has been recently developed in the past few years in an effort to decrease the above perioperative complications typically related to cardiopulmonary bypass associated with on-pump CABG. While registries suggest that off-pump CABG may be superior, these data cannot fully control for differences in patient characteristics, which influence patient selection for specific procedures. The benefits of off-pump CABG compared with conventional on-pump CABG are unclear. The investigators therefore propose a large simple, international multicentre randomized controlled trial to definitively evaluate the efficacy and safety of off-pump CABG in the treatment of patients undergoing coronary artery surgery funded by CIHR, this pilot study will be a preliminary step towards a full trial.
Sample size:
The investigators examined the outcomes in the Canadian off-pump CABG Registry to identify a group of patients who represent a higher risk of cardiovascular events. Utilizing the inclusion criteria described below, this group of patients has accumulated the vast majority of outcomes in the Registry and represent more than 50% of patients in the Registry, therefore minimizing the sample size but still being representative. The cumulative event rate at 30 days (first co-primary outcome) for on-pump CABG is estimated as being 8.6% and the investigators expect a 33% relative risk reduction (RRR) for the off-pump CABG group. The sample calculated for the whole trial is 4700 patients.
Design/Methodology:
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed with coronary artery disease (single, double or triple disease) will be eligible if they:
- •require isolated CABG with median sternotomy
- •are able to give their informed written consent
- •are> 21 years of age and
- •have one or more of the following risk factors:
- •≥ 70 years
- •peripheral vascular disease (previous peripheral bypass or amputation or ABI <0.80)
- •Cerebrovascular disease (history of stroke, TIA)
- •Renal insufficiency (creatinine above upper limit of normal)
- •>60 years of age and one of the following:
- •diabetes (oral hypoglycemic agent and/or insulin)
- •urgent revascularization (waiting in hospital)
- •LV ejection fraction <35%
- •current or recent smoker.
- •55-59 years of age and two of the following:
- •diabetes (oral hypoglycemic agent and/or insulin)
- •urgent revascularization (waiting in hospital)
- •LV ejection fraction <35%
- •current or recent smoker.
排除标准
- •Patients will be excluded if they have one of the following:
- •concomitant cardiac procedure associated with CABG,
- •contra-indications to off-pump CABG or on-pump CABG (calcified aorta, intramuscular LAD, calcified coronaries, small target vessels)
- •concomitant life-threatening disease likely to limit life expectancy to less than 2 years,
- •prior enrollment in this trial
- •emergency CABG surgery (immediate revascularization for hemodynamic instability) OR
结局指标
主要结局
First Co-Primary Outcome
时间窗: 30 days post CABG surgery
The occurrence of the composite of total mortality, stroke, nonfatal MI, or new renal failure at 30 days post CABG surgery
Second co-primary outcome
时间窗: 5 years after CABG
The occurrence of the composite of total mortality, stroke, nonfatal MI, new renal failure, or repeat coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) over 5 years after randomization.
次要结局
- The assessment of total costs and resources consumption at 5 years after CABG surgery(5 years after CABG surgery)
- The assessment of total costs and resources consumption at 30 days after CABG surgery(30 days after CABG surgery)
研究者
Andre Lamy
Cardiac Surgeon
Population Health Research Institute