Abstract 13135: The Clinical Significance of Intraoperative Iloprost Inhalation on Outcome of High Risk Cardiac Surgical Patients: A Multicenter Randomized Controlled Trial

Abstract

Background: Perioperative right ventricular (RV) failure due to pressure overload resulting from pulmonary hypertension (PH) worsens postoperative outcomes in cardiac surgery. Inhaled iloprost is a potent pulmonary vasodilator improving biventricular performance, ameliorating myocardial and pulmonary ischemia-reperfusion injury and attenuating inflammation. We hypothesized that the prophylactic inhalation of iloprost improves postoperative outcome in patients undergoing elective open heart surgery being at an increased risk for perioperative RV failure. Methods and Results: In this phase 3, multicenter, randomized, double-blind, placebo-controlled trial, we randomly assigned 253 cardiac surgical patients at high risk for perioperative RV failure to the prophylactic inhalation of 20μg iloprost or placebo before and during weaning from extracorporeal circulation (ECC). The primary endpoint was the duration of postoperative ventilation. Secondary endpoints included perioperative hemodynamics, intensive care unit and hospital length of stay, and 90-days mortality. Safety was assessed by the incidences of adverse events. Iloprost had no significant effect on the time until extubation (iloprost: median: 720min [first quartile, third quartile][540min; 1218min]; placebo: 780min [468min; 1170min]; p=0.37). While the nebulization of iloprost decreased RV afterload and improved cardiac index, major secondary endpoints were not significantly affected. Treatment with iloprost was safe with the incidences of adverse events not differing between groups. Conclusions: The prophylactic inhalation of iloprost does not result in any meaningful improvement of perioperative morbidity and outcome in high-risk cardiac surgical patients. Clinical Trial Registration: URL: http://www.clinicaltrialsregister.eu . Unique identifier: EudraCT-number: 2008-002090-12; URL: http://www.clinicaltrials.gov . Unique identifier: NCT00927654