Coronary Bypass Grafting With Minimal Extracorporeal Circulation System Versus Off-pump Coronary Surgery

Study Overview
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Brief Summary
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The investigators aimed to evaluate the clinical results and the inflammatory response of the minimal extracorporeal circulation system (MECC) Compared with off-pump coronary revascularization (OPCABG). This is a randomized and prospective study in 230 patients with indications for coronary surgery, with 113 patients in the OPCABG group and 117 in the MECC group. The endpoints were the clinical and biochemical results, intra-operative outcomes and the determination of 19 inflammatory circulating markers, 17 of them for the first time analyzed comparing both techniques.

Official Title
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Prospective Randomized Comparison of Coronary Bypass Grafting With Minimal Extracorporeal Circulation System (MECC) Versus Off-pump Coronary Surgery. New Insights Into Inflammatory Cytokines.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Off-pump coronary artery bypass graft
* Procedure: Mini extracorporeal circulation bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for coronary surgery established on the basis of current published guidelines Exclusion Criteria: Documented preoperative systemic proinflammatory status and/or steroid administration within 6 months before surgery. Coexistence of a cardiomyopathy different than coronary artery disease that precise surgical treatment. Left ventricle ejection fraction of 40% or less. Treatment with erythropoietin (EPO) three months before the intervention Hematocrit less than 35% the day prior to the procedure Redo surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Off-pump coronary artery bypass graft<br>Patients operated on with off-pump coronary artery bypass graft, beating heart surgery. | Procedure: Off-pump coronary artery bypass graft<br>* Patients operated with the heart beating, without heart arrest.<br>|
| Mini extracorporeal circulation bypass<br>Patients operated on with mini extracorporeal circulation bypass. A modified extracorporeal system. | Procedure: Mini extracorporeal circulation bypass<br>* Patients operated with a modified extracorporeal circulation system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes | Number of Participants with Adverse Events, e.g, renal failure, atrial fibrillation, acute myocardial infarct, stroke, redo surgery, death. | within the first 30 days (plus or minus 3 days) after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of increase over the first 48 hours of plasma levels of 19 circulating markers of inflammatory response. | Determination of increase over the first 48 hours after the operation of plasma levels of 19 circulating markers of inflammatory response. The levels of inflammatory markers are measured in pg / mL and subsequently, the increase over the 48 hours is determined with the area under the curve. | Area Under the Concentration-Time Curve (AUC 0-48 hours) | 
| Biochemical outcomes | Changes in creatine kinase levels, troponin levels, glucose, leukocytes, platelets, hemoglobin and hematocrit levels. From basal point to 48 hours time after surgery. | Within the first 30 days (plus or minus 3 days) after surgery | 
| Operative results | Number of distal anastomosis. | Within the first 30 days (plus or minus 3 days) after surgery | 
| Operative results | Type of grafts used. | Within the first 30 days (plus or minus 3 days) after surgery | 
| Operative results | time until removal of mechanical respiratory support | Within the first 30 days (plus or minus 3 days) after surgery | 
| Operative results | Time at intensive care unit (days) | Within the first 30 days (plus or minus 3 days) after surgery | 
| Operative results | Total hospitalization time (days) | Within the first 30 days (plus or minus 3 days) after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Off-pump bypass graft surgery, Mini extracorporeal circulation bypass surgery