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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
Sponsor:
Collaborators:
Danish Heart Foundation
The Danish Medical Research Council
Copenhagen Hospital Corporation
Information provided by:
Rigshospitalet, Denmark

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Disease Cardiovascular Disease Procedure: Coronary artery bypass grafting Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. All cause mortality [ Time Frame: Short and long term ]
  2. Acute myocardial infarction
  3. Cardiac arrest with successful resuscitation
  4. Low cardiac output syndrome/cardiogenic shock
  5. Stroke
  6. Need for renewed cardiac revascularization procedure

Secondary Outcome Measures :
  1. Hyper dynamic shock
  2. Atrial fibrillation during index admission
  3. Need for pacing > 24 hours
  4. Renal complications, i.e., increased serum creatinine
  5. Reoperation for bleeding during index admission
  6. Pneumonia
  7. Respiratory insufficiency requiring intubation > 24 hours postoperatively
  8. Serious adverse events
  9. Duration of stay in intensive care unit
  10. Duration of stay in the hospital
  11. Quality of life after 3 and 12 month
  12. Graft patency at one year postoperatively defined by coronary angiography.

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Denmark
Dept. Cardiothoracic Surgery, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Heart Foundation
The Danish Medical Research Council
Copenhagen Hospital Corporation
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dept Cardiothorax Surgery, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00120991    
Other Study ID Numbers: 2001-11-DP-83-RKF-22
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: March 3, 2008
Last Verified: February 2008
Keywords provided by Rigshospitalet, Denmark:
Coronary artery bypass grafting
OPCAB
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases