Best Bypass Surgery (BBS) Trial

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00120991
• Other study ID #: 2001-11-DP-83-RKF-22
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 8, 2005
• Last updated: February 29, 2008
• Start date: April 2002
• Est. completion date: July 2008

Study information

• Verified date: February 2008
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 341
• Est. completion date: July 2008
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Heart Disease

Intervention

Procedure:
• Coronary artery bypass grafting

Locations

Country	Name	City	State
Denmark	Dept. Cardiothoracic Surgery, Rigshospitalet	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen Hospital Corporation, Danish Heart Foundation, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		Short and long term	No
Primary	Acute myocardial infarction			No
Primary	Cardiac arrest with successful resuscitation			No
Primary	Low cardiac output syndrome/cardiogenic shock			No
Primary	Stroke
Primary	Need for renewed cardiac revascularization procedure
Secondary	Hyper dynamic shock
Secondary	Atrial fibrillation during index admission
Secondary	Need for pacing > 24 hours
Secondary	Renal complications, i.e., increased serum creatinine
Secondary	Reoperation for bleeding during index admission
Secondary	Pneumonia
Secondary	Respiratory insufficiency requiring intubation > 24 hours postoperatively
Secondary	Serious adverse events
Secondary	Duration of stay in intensive care unit
Secondary	Duration of stay in the hospital
Secondary	Quality of life after 3 and 12 month
Secondary	Graft patency at one year postoperatively defined by coronary angiography.