Arterial Revascularization for Coronary Bypass Surgery: A Randomized Trial Comparing the Outcome After Using LIMA + Vein Grafts Versus Total Arterial Revascularization With LIMA + RIMA + Radial Artery Grafts
试验速览
- 阶段
- 3 期
- 入组人数
- 331
- 试验地点
- 2
- 主要终点
- Angiographic distal anastomotic patency rates
研究概览
简要总结
There is a remarkable lack of randomized trials concerning the potential benefit of using arterial conduits for coronary bypass surgery. This is the purpose of the present trial. Exclusive use of arterial conduits might result in improved conduit viability, reduced risk of recurrent angina, myocardial infarction and other cardiac events, reduced need for antianginal medication, improved functional status and possibly improved long term survival. The patients will be followed for ten years after surgery.
详细描述
I: Background
There is a remarkable lack of randomized studies concerning the potential benefit of using arterial grafts for coronary revascularization. Numerous observational reports consistently confirm, that the use of a LIMA-LAD grafts is not associated with increased peroperative mortality or morbidity and will result in an approximately 10% improved survival at 10 years postoperatively.
The average patency for LIMA-LAD grafts is 80%-85% after 10 years. 50% of the vein grafts are occluded. LIMA-LAD grafting reduces the risk of of late myocardial infarction, other cardiac events and reoperation, however the effect on recurrent angina or need of antianginal medication is less certain.
The question, whether bilateral IMA grafting has long term benefits compared to single IMA grafts is controversial. Numerous observational retrospective studies fail to demonstrate convincingly, that bilateral IMA grafting reduces long term mortality and improves the frequency of late cardiac events and recurrent angina, but these data are difficult to compare due to selection bias. It is not quite clear, if a minimal benefit represents a true difference in outcome, or if two different populations are compared.
Whether an increased degree of arterial revascularization, including radial artery (RA) and IMA grafts, will result in an improved long term survival, reduced risk for recurrent angina, reinfarction, antianginal medication and improved quality of life, is unclear.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with 2 or 3 vessel coronary artery disease, where more than 1 coronary bypass graft is anticipated.
- •Elective or subacute operation (unstable AP with surgery within a few days)
- •Inclusion is independent of ventricular function, recent MI, degree and type of coronary lesions and secondary risk factors as diabetes, hyperlipidemia, hypertension, lung function, chronic obstructive lung disease, peripheral atherosclerotic disease, kidney function, earlier cerebrovascular disease.
- •Age: < 70 years.
- •Sufficient collateral blood supply to the hand by the ulnar artery, evaluated by the Allen test.
- •Patients must be able to give informed consent.
排除标准
- •Concurrent malignant disease with expected survival of < 5 years.
- •Unsuitable saphenous vein grafts evaluated preoperatively.
- •Unsuitable saphenous vein grafts with a diameter > 6mm evaluated preoperatively.
- •Acute operation (unstable hemodynamics in terms of need of inotropic support, ongoing MI with dynamic ECG changes, cardiogenic shock).
- •Concommitant operation for valve disease or other forms of heart surgery. Redo operations.
结局指标
主要结局
Angiographic distal anastomotic patency rates
时间窗: 1, 5 and 10 years postoperatively
Cardiac event free survival
时间窗: 1, 5 and 10 years postoperatively
次要结局
- Peroperative mortality(Until 3 months postoperatively)
- Postoperative morbidity (frequency of peroperative/ postoperative infarction, arrythmias, use of IABP, inotropic support, pulmonary, renal and cerebral complications, length of stay in the ICU, etc. according to registration schemes).(3 months postoperatively)
- Risk of recurrent angina and need for antianginal medication(1, 5 and 10 years postoperatively)
- Data on functional status and social rehabilitation at clinical controls(3 months, 1, 5 and 10 years postoperatively)