Best Bypass Surgery (BBS) Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Off-Pump Coronary Artery Bypass Grafting Versus Conventional Coronary Artery Bypass Grafting on Postoperative Mortality and Morbidity, A Randomized Clinical Trial

Conditions
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Heart Disease, Cardiovascular Disease

Intervention / Treatment
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* Procedure: Coronary artery bypass grafting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Coronary artery bypass grafting|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | Short and long term | 
| Acute myocardial infarction |  |  | 
| Cardiac arrest with successful resuscitation |  |  | 
| Low cardiac output syndrome/cardiogenic shock |  |  | 
| Stroke |  |  | 
| Need for renewed cardiac revascularization procedure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyper dynamic shock |  |  | 
| Atrial fibrillation during index admission |  |  | 
| Need for pacing > 24 hours |  |  | 
| Renal complications, i.e., increased serum creatinine |  |  | 
| Reoperation for bleeding during index admission |  |  | 
| Pneumonia |  |  | 
| Respiratory insufficiency requiring intubation > 24 hours postoperatively |  |  | 
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery bypass grafting, OPCAB