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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau230 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

230

Conditions

Coronary Artery Disease

Interventions

Off-pump coronary artery bypass graftPROCEDURE

Patients operated with the heart beating, without heart arrest.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical outcomes

Number of Participants with Adverse Events, e.g, renal failure, atrial fibrillation, acute myocardial infarct, stroke, redo surgery, death.

Time frame: within the first 30 days (plus or minus 3 days) after surgery

Secondary Outcomes

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.

Time frame: 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.