Free poster sessions Oral session XII – Preselected best posters P-01
Clinical experience with a novel serine-protease inhibitor (MDCO-2010) in on-pump CABG surgery Gabor Erdoes1, Lars Englberger1, Wulf Dietrich2, Andreas Van De Locht3, Susanne Lison2, Thierry P Carrel1, Balthasar Eberle1 1 University Hospital Berne, Berne, Switzerland, 2Ludwig-Maximilians-University, Munich, Germany, 3The Medicines Company, Munich, Germany Introduction: MDCO-2010, a synthetic serine-protease inhibitor, exhibits marked antifibrinolytic and moderate anticoagulant activity in vitro [1]. The aims of the study were to describe pharmacokinetics, safety and pharmacodynamics of this novel antifibrinolytic in patients undergoing coronary artery bypass grafting (CABG). Exploratory endpoints were chest tube drainage, transfusions, incidence of re-exploration and perioperative mortality. Method: With Ethics Committee approval and patient informed consent, a double-blind placebo-controlled study was performed in 32 patients undergoing elective CABG on minimized cardiopulmonary bypass. Patients were randomized to receive placebo (cohort P: n=8), or one of the following study drug dose regimens (cohorts C1, C2 each n=3; C3-5 each n=6): a loading dose and a pump priming dose of MDCO-2010 followed by an infusion of 12.5, 25, 62.5, 109 or 219 mcg kg-1 h-1 until sternal closure. Conventional and point-of-care analyses of coagulation and fibrinolysis were used to describe pertinent properties of MDCO-2010 in vivo. Data (median [25th/75th percentile]) of cohorts C (all
drug dose regimens) vs. P were compared (SPSS software, non-parametric tests, significance P
