Clinical Trial: Best Bypass Surgery (BBS) Trial

This study is currently recruiting patients.

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

Purpose

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 Intervention Phase
Heart Disease
Cardiovascular Disease
 Procedure: Coronary artery bypass grafting
Phase III

MedlinePlus related topics:  Heart Diseases;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Off-Pump Coronary Artery Bypass Grafting Versus Conventional Coronary Artery Bypass Grafting On Postoperative Mortality and Morbidity, a Randomized Clinical Trial

Further Study Details: 
Primary Outcomes: All cause mortality; Acute myocardial infarction; Cardiac arrest with successful resuscitation; Low cardiac output syndrome/cardiogenic shock; Stroke; Need for renewed cardiac revascularization procedure
Secondary Outcomes: 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.
Expected Total Enrollment:  330

Study start: April 2002;  Expected completion: January 2008
Last follow-up: April 2007;  Data entry closure: October 2007

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.

Eligibility

Ages Eligible for Study:  55 Years and above,  Genders Eligible for Study:  Both
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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00120991

Daniel A. Steinbrüchel, Professor      +45 35452516    dast@rh.dk
Pia Hughes, PhD      +45 35457171    phughes@ctu.rh.dk

Denmark
      Dept. Cardiothoracic Surgery, Rigshospitalet, Copenhagen,  2100,  Denmark; Recruiting
Daniel A. Steinbrüchel, Professor  +4535452516    dast@rh.dk 
Pia Hughes, Phd  +45 35457171    phughes@ctu.rh.dk 

Study chairs or principal investigators

Pia Hughes, Phd,  Principal Investigator,  Copenhagen Trial Unit and Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen   
Daniel A. Steinbrüchel, Professor,  Study Director,  Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen   
Christian N. Gluud, Consultant,  Study Chair,  Copenhagen Trial Unit, Rigshospitalet, Copenhagen   
Jan K. Madsen, Consultant,  Study Chair,  Dept. of Cardiology, Amtssygehuset i Gentofte, Copenhagen   

More Information

Study ID Numbers:  2001-11-DP-83-RKF-22
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 18, 2005
ClinicalTrials.gov Identifier:  NCT00120991
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-07-26

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