Arrested Versus Beating Heart Techniques in Coronary Revascularisation

Study Overview
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Brief Summary
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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.

Official Title
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Arrested Versus Beating Heart Techniques in Coronary Revascularisation: Randomized Clinical Trial in Unselected Patients

Conditions
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Coronary Artery Bypass Grafting

Intervention / Treatment
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* Procedure: Conventional Coronary Artery Bypass
* Procedure: Off-Pump Coronary Artery Bypass
* Procedure: Pump-Assisted Coronary Artery Bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CCAB<br>Conventional Coronary Artery Bypass | Procedure: Conventional Coronary Artery Bypass<br>* Coronary artery bypass grafting with extracorporeal circulation and cardioplegic arrest<br>|
| Active Comparator: OPCAB<br>Off-Pump Coronary Artery Bypass | Procedure: Off-Pump Coronary Artery Bypass<br>* Coronary artery bypass grafting without extracorporeal circulation or global myocardial ischemia<br>|
| Active Comparator: PACAB<br>Pump-Assisted Coronary Artery Bypass | Procedure: Pump-Assisted Coronary Artery Bypass<br>* Coronary artery bypass grafting with a beating but unloaded heart by using extracorporeal circulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 1, 6, 12, 24, 48 month | 
| Myocardial infarction |  | 1, 6, 12, 24, 48 month | 
| Stroke |  | 1, 6, 12, 24, 48 month | 
| Low-output syndrome |  | in hospital | 
| duration of ventilation >= 24h |  | in hospital | 
| New requirement of hemodialysis |  | in hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completeness of revascularization |  | in hospital | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary disease, Coronary artery bypass grafting, Cardiopulmonary bypass, Extracorporeal circulation, Cardioplegia, Off pump