Best Bypass Surgery (BBS) Trial

February 29, 2008 updated by: Rigshospitalet, Denmark

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

341

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Dept. Cardiothoracic Surgery, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: Short and long term
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

The Danish Medical Research Council
Danish Heart Foundation
Copenhagen Hospital Corporation

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

March 1, 2006

Study Completion (Anticipated)

July 1, 2008

Study Registration Dates

First Submitted

July 8, 2005

First Submitted That Met QC Criteria

July 18, 2005

First Posted (Estimate)

July 19, 2005

Study Record Updates

Last Update Posted (Estimate)

March 3, 2008

Last Update Submitted That Met QC Criteria

February 29, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001-11-DP-83-RKF-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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