Best Bypass Surgery (BBS) Trial
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|ClinicalTrials.gov Identifier: NCT00120991|
Recruitment Status : Unknown
Verified February 2008 by Rigshospitalet, Denmark.
Recruitment status was: Active, not recruiting
First Posted : July 19, 2005
Last Update Posted : March 3, 2008
|Condition or disease||Intervention/treatment||Phase|
|Heart Disease Cardiovascular Disease||Procedure: Coronary artery bypass grafting||Phase 3|
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.
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||341 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Off-Pump Coronary Artery Bypass Grafting Versus Conventional Coronary Artery Bypass Grafting on Postoperative Mortality and Morbidity, A Randomized Clinical Trial|
|Study Start Date :||April 2002|
|Actual Primary Completion Date :||March 2006|
|Estimated Study Completion Date :||July 2008|
- All cause mortality [ Time Frame: Short and long term ]
- Acute myocardial infarction
- Cardiac arrest with successful resuscitation
- Low cardiac output syndrome/cardiogenic shock
- Need for renewed cardiac revascularization procedure
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120991
|Dept. Cardiothoracic Surgery, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Christian H. Møller, MD||Dept. of Cardiothoracic Surgery and Copenhagen Trial Unit, Rigshospitalet, Copenhagen|
|Study Director:||Daniel A. Steinbrüchel, Professor||Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen|
|Study Chair:||Christian Gluud, Consultant||Copenhagen Trial Unit, Rigshospitalet, Copenhagen|
|Study Chair:||Jan K. Madsen, Consultant||Dept. of Cardiology, Amtssygehuset i Gentofte, Copenhagen|