Best Bypass Surgery (BBS) Trial

Rigshospitalet

Status and phase

Unknown

Phase 3

Conditions

Heart Disease

Cardiovascular Disease

Treatments

Procedure: Coronary artery bypass grafting

Study type

Interventional

Funder types

Other

Identifiers

NCT00120991

2001-11-DP-83-RKF-22

Details and patient eligibility

About

There is evidence linking cardiopulmonary bypass to negative side effects when used for coronary artery bypass grafting. Coronary artery bypass grafting can be performed without the use of cardiopulmonary bypass. The purpose of this study is to determine the positive and negative effects of coronary artery bypass grafting with or without the use of cardiopulmonary bypass. The patients will be followed at least one year after surgery.

Full description

Objectives:

To evaluate the beneficial and harmful effects of off-pump coronary artery bypass grafting (OPCAB) versus conventional coronary artery bypass grafting (CCABG) using a heart- and lung machine in patients with three-vessel coronary artery disease.

Trial population:

Consecutive patients > 54 years of age with three-vessel coronary artery disease with EuroSCORE of 5-16 undergoing elective or sub-acute coronary artery bypass grafting, giving written informed consent, and where randomisation can be accomplished preoperatively. The study will include 330 patients.

Trial design:

The Best Bypass Surgery Trial (BBS Trial) is a randomised trial. Patients will be randomised to one of two groups. The randomisation will be 1:1, in blocks, stratified by gender, age (55 to 65 years; > 65 years), diabetes mellitus, and EuroSCORE (5-7; 8-10; 11-13; 14-16). The patients will be randomised to OPCAB surgery or CCABG surgery.

The interventions:

In the OPCAB group, the revascularization procedure will be performed on the beating heart with a stabilizer to demobilize the target coronary arteries. When access is needed for posterior coronary arteries a suction device will lift the heart. In the CCABG group, the revascularization procedure will be performed with the use of a heart- and lung machine in normothermia, aortic cross clamp, and with cold cardioplegic arrest. In both groups, the left internal mammary artery and saphenous vein grafts are standard graft material.

Outcome measures:

The aim of the study is to examine the value of OPCAB revascularization compared to CCABG revascularization on the following outcome measures:

Primary: The composite outcome measure of mortality (of all causes), acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome, or major neurological deficit.
Secondary: Hyper dynamic shock; atrial fibrillation, respiratory insufficiency requiring intubation >24 hours , need for pacing > 1 day due to 2º AV-blockage or nodal rhythm; renal complications, i.e., serum creatinine > 200 μmol/l, or need for acute dialysis; re-operation for bleeding, pneumonia; serious adverse events; duration of stay in intensive care unit; duration of stay in the hospital; quality of life after 3 and 12 month; graft patency at one year postoperatively defined by coronary angiography. In addition, cognitive function will be assessed after three and 12 months in the first 120 patients randomized.

Enrollment

341 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Known ischemic three vessel heart disease affecting one of the marginal coronary arteries
Age > 54 years
Scheduled for elective or subacute CABG
EuroSCORE > 4 and < 17
The patient has signed written informed consent before randomization and surgery.

Exclusion criteria

Previous heart surgery
Ejection fraction < 30 %
Unstable preoperative condition, i.e., continuous infusion of inotropics on the day of the operation
Patient unable to give informed consent.