Background: Coronary artery by-pass grafting (CABG) can be performed either with or without the use of cardiopulmonary bypass (CPB) to obtain myocardial re-vascularisation. We 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.

Condition	Intervention	Phase
Ischemic Heart Disease	Procedure: Off-pump Coronary Artery By-pass Grafting	Phase IV

Further Study Details: 

Primary Outcomes: A combined end-point of death + stroke + myocardial infarction within 30 days from operation
Secondary Outcomes: a) A combined end-point of death + stoke + myocardial infarction during follow-up; b) Patency of by-pass grafts assessed by coronary angiography 6 months after the operation.; c) Total mortality and cardiac mortality during follow-up.; d) Need of new intervention for cardiac angina during follow-up.; e) Quality of life assessed by MOS SF-36 and EuroQol questionnaires 6 months and 3 years after the operation.; f) 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.
Expected Total Enrollment:  900

Conventional Coronary artery by-pass 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 by-pass 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. We 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 by-pass.

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.

Ages Eligible for Study:  70 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• age seventy years or above admitted for first time coronary artery by-pass operation.

Exclusion Criteria:

• Given information cannot be understood, aortic crossclamping not safe due to calcification, preoperative cardiac conditions demanding cardio- pulmonary by-pass. Re-do cardiac surgery. Patients requiring operation within the same day after conference.

Please refer to this study by ClinicalTrials.gov identifier  NCT00123981

Kim C Houlind, MD, PhD      +45 89 49 55 66  Ext. 5447    kim.houlind@iekf.au.dk

Denmark
      Dept. of Cardiothoracic and Vascular Surgery, Skejby Sygehus, Aarhus University Hospital, Aarhus,  8200,  Denmark; Recruiting

Study chairs or principal investigators

Kim C Houlind, MD, PhD,  Principal Investigator,  Aarhus University Hospital   
Poul E Mortensen, MD,  Study Chair,  Odense University Hospital   

Study ID Numbers:  DTS-0001
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 25, 2005
ClinicalTrials.gov Identifier:  NCT00123981
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
ClinicalTrials.gov processed this record on 2005-07-26