The Danish On-pump, Off-pump Randomization Study (DOORS)
- Conditions
- Ischemic Heart Disease
- Interventions
- Procedure: Off-Pump Coronary Artery Bypass Grafting
- Registration Number
- NCT00123981
- Lead Sponsor
- Kim Houlind
- Brief Summary
Background: Coronary artery bypass grafting (CABG) can be performed either with or without the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. The investigators hypothesize that CABG without the use of CPB may reduce the risk of perioperative death, stroke, myocardial infarction and other serious complications.
The aim of the present study is to compare the incidence of complications and the clinical efficacy of CABG with and without the use of CPB in elderly patients.
- Detailed Description
Conventional coronary artery bypass grafting (CCABG) using cardiopulmonary bypass has for decades been applied to obtain myocardial re-vascularisation and, hence, improved quality of life and survival. It does, however, bear a risk of death, stroke, myocardial infarction and other serious complications.
During recent years, an equivalent operation performed on the beating heart without cardiopulmonary bypass (off-pump coronary artery bypass grafting, OPCAB) has gained popularity helped by the advent of mechanical stabilization devices and improved surgical techniques. Observational studies suggest that this technique is associated with a lower incidence of stroke, per operative arrhythmias and even mortality than conventional CCABG. This is especially the case in elderly patients and patients with significant co-morbidity.
Only few randomised, controlled trials have been conducted and most of these included mainly or only low-risk, relatively young patients. These studies have documented the safety and efficacy of OPCAB compared with CCABG, but none of the trials has had the statistical strength to determine whether the rate of serious complications is lower after OPCAB operations. One recent study found graft patency to be significantly lower after OPCAB than after CCABG operations.
The investigators find that there is a need of a larger scale randomised trial to compare the results of CCABG and OPCAB operations, especially in elderly patients. This patient group is poorly represented in earlier randomised trials, whereas observational studies and theoretical considerations imply that they may benefit the most from avoiding cardiopulmonary bypass.
Aims: Primarily, to compare the incidence of death, stroke and myocardial infarction after CCABG and OPCAB procedures in a population of elderly patients. Furthermore, to compare quality of life and graft patency, and cost- effectiveness after CCABG and OPCAB.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
- Age seventy years or above
- Admitted for first time coronary artery bypass operation
- Given information cannot be understood
- Aortic crossclamping not safe due to calcification
- Preoperative cardiac conditions demanding cardiopulmonary bypass
- Re-do cardiac surgery
- Patients requiring operation within the same day after conference
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OPCAB Off-Pump Coronary Artery Bypass Grafting Coronary artery bypass surgery NOT using cardiopulmonary bypass CCABG Off-Pump Coronary Artery Bypass Grafting Coronary artery bypass surgery using cardiopulmonary bypass
- Primary Outcome Measures
Name Time Method A combined endpoint of death + stroke + myocardial infarction within 30 days from operation 30 days
- Secondary Outcome Measures
Name Time Method A combined endpoint of death + stroke + myocardial infarction during follow-up 3 years Patency of bypass grafts assessed by coronary angiography 6 months after the operation 6 months Total mortality and cardiac mortality during follow-up 3 years Total hospital costs and costs of public care provided 6 months and 3 years after the operation and difference in costs per quality adjusted life year 6 months and 3 years Need of new intervention for cardiac angina during follow-up 3 years Quality of life assessed by MOS SF-36 and EuroQol questionnaires 6 months and 3 years after the operation 6 months and 3 years
Trial Locations
- Locations (1)
Dept. of Cardiothoracic and Vascular Surgery, Skejby Sygehus, Aarhus University Hospital
🇩🇰Aarhus, Denmark