Coronary Artery Bypass Grafting
Conditions
Keywords
Coronary disease, Coronary artery bypass grafting, Cardiopulmonary bypass, Extracorporeal circulation, Cardioplegia, Off pump
Brief summary
The individual contribution of the specific injuring mechanisms surgical trauma, extracorporeal circulation, and ischemia/reperfusion to clinical outcome in coronary revascularisation remains to be elucidated. The effect of these factors is analyzed in this randomized clinical trial by comparing the 3 surgical approaches: Conventional Coronary Artery Bypass Grafting (CCAB), with extracorporeal circulation and cardioplegic arrest; Off-Pump Coronary Artery Bypass Grafting (OPCAB), avoids extracorporeal circulation and global myocardial ischemia; and Pump-Assisted Coronary Artery Bypass Grafting (PACAB), with an unloaded and beating heart. The hypothesis addressed by the study is that the surgical invasiveness increases in the order: OPCAB, PACAB, CCAB.
Interventions
PROCEDUREConventional Coronary Artery Bypass
Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest
PROCEDUREOff-Pump Coronary Artery Bypass
Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia
PROCEDUREPump-Assisted Coronary Artery Bypass
Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation
Sponsors
Medtronic
Martin-Luther-Universität Halle-Wittenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with double- or triple-vessel coronary artery disease * patients with left ventricular ejection fraction =\< 40% or \>= 60% * elective or urgent isolated coronary artery bypass grafting
Exclusion criteria
* previous cardiac surgery * emergency indications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New requirement of hemodialysis | in hospital |
| Stroke | 1, 6, 12, 24, 48 month |
| Low-output syndrome | in hospital |
| duration of ventilation >= 24h | in hospital |
| All cause mortality | 1, 6, 12, 24, 48 month |
| Myocardial infarction | 1, 6, 12, 24, 48 month |
Secondary
| Measure | Time frame |
|---|---|
| Re-revascularization of the target vessel (PCI and/or CABG) | 1, 6, 12, 24, 48 month |
| Resource use (operative time, duration of stay in the intensive care unit, total hospital stay) | in hospital |
| Completeness of revascularization | in hospital |
Countries
Germany
Outcome results
None listed