Extract

Background and study aims A coronary artery bypass graft (CABG) is a surgical procedure that diverts blood around narrowed or clogged arteries of the heart to improve blood flow and oxygen supply to the heart. CABG surgery provides excellent short and intermediate term success in treating coronary heart disease but its long-term success may be limited by failure of the veins that have been used to bypass the blood vessels of the heart. Ten years after CABG, around ½ of vein grafts have become blocked or diseased although current drug therapy such as aspirin and statins (which lower cholesterol) may reduce this failure. Blocked or diseased vein grafts means that the patient may develop recurrent angina (chest pain) and may require further treatment including the possibility of another operation. The artery grafts last better than the vein grafts. There is some circumstantial (but no definite) evidence that if both of the mammary arteries are used in the CABG operation instead of just one it may improve the longer-term outcome. The aim of the ART study is to determine if the use of both mammary arteries improves survival, and reduces the chance of recurrent angina and/or the need for further intervention (including surgery) compared to using one mammary artery. Patients will be followed up for 10 years after surgery. Who can participate? CABG patients with coronary heart disease. What does the study involve? Patients are randomized to receive either a single internal mammary artery (SIMA) graft or a bilateral internal mammary artery (BIMA) graft during their CABG surgery. Patients are then followed up every year for up to 10 years after their surgery. Data is collected on their health status and quality of life. What are the possible benefits and risks of participating? The possible disadvantages and risks of taking part are common to all patients undergoing CABG surgery.The possible disadvantages of BIMA grafting is that there may be a slightly increased risk of poor wound healing. The risk of poor wound healing with the standard SIMA operation is 1%-2% and this may increase by a further 1% in the BIMA group. However, this is usually only a problem in those with diabetes, or who are already very overweight or have severe breathing problems. A further consideration is that BIMA grafting has a slightly longer operation time (approximately 30 minutes in a three hour procedure) than SIMA grafting. Patients taking part in the study will be asked to complete quality of life questionnaires which may be regarded by some as an inconvenience. Both the SIMA grafting and the BIMA grafting should help treat the patient’s coronary heart disease. The possible advantages of BIMA grafting are that there may be a reduced risk of angina, heart attack and a requirement for further intervention, including the possibility of a second CABG operation in the long term. It is not possible to say definitively which type of grafting is better but the information from this study should help to decide the best treatment in the future for patients with coronary heart disease. Where is the study run from? Department of Cardiothoracic Surgery, The John Radcliffe When is the study starting and how long is it expected to run for? July 2004 to June 2014 Who is funding the study? 1. British Heart Foundation 2. Medical Research Council Who is the main contact? Professor David Taggart

Inclusion criteria

• Cardiovascular

Links

• isrctn
• ictrp