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Inhaled Temperature-Stable Epoprostenol Is Equivalent to Inhaled Nitric Oxide in Post-Cardiac Surgery Patients with Pulmonary Hypertension

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Conference: 2014 International PHA Conference and Scientific Sessions

Release Date: 06.21.2014

Presentation Type: Abstracts

File Download: 2014 Conference Abstract - Hadi Chohan

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Background: Inhaled pulmonary vasodilators are used in different acute settings including refractory hypoxic respiratory failure, pulmonary hypertension, and post-cardiac surgery patients. Recently, studies have shown equivalence of inhaled epoprostenol with inhaled nitric oxide (iNO) in critically ill patients with hypoxic respiratory failure. Pulmonary hypertension is usually present in patients undergoing cardiac surgery or can be worsened by cardiopulmonary bypass. Outcomes in post-cardiac surgery patients receiving inhaled prostacyclin and iNO are improved compared with intravenous vasodilators. A newer formulation of epoprostenol with arginine-mannitol excipients (epoprostenol AM; Veletri [Actelion Pharmaceuticals Ltd, Allschwil, Switzerland]) has been introduced containing different inactive excipients resulting in greater stability at room temperature.  However, there has not been a study evaluating outcomes between inhaled temperature-stable epoprostenol (iEPO-AM) and iNO in this subset of patients.  

Methods: A single center retrospective study of patients admitted to the Cardiac Surgery Intensive Care Unit (CSICU) was performed between 2011 and 2012. All the patients were post-cardiac surgery including coronary artery bypass grafting (CABG), left-ventricular assist device (LVAD), or orthotopic heart transplantation. Primary outcome included days on inhaled therapy with secondary outcomes of hospital length of stay (LOS) and ventilator-free days.

Results: Nine patients with iEPO-AM therapy were compared to 10 patients with iNO therapy. Two-sided and one-sided t-test statistical analysis was performed to evaluate for significance and inferiority of iEPO-AM to iNO therapy. iEPO-AM was found to be non-inferior to iNO therapy with the primary endpoint of days of therapy (5.2 days versus 7.6 days [p=0.22]) as well as the hospital LOS (55.8 days versus 148.7 days [p=0.09]).  Ventilator-free days were 83.1 days for the iNO group versus 51.3 days for iEPO-AM which was not statistically significant (p=0.25), but could not exclude inferiority with one-sided t-test analysis.  

Conclusions: This is the first reported study of a head-to-head analysis of iEPO-AM versus iNO in post-cardiac surgery patients. The findings showed iEPO-AM to be non-inferior to iNO with trends towards shortened duration of therapy and hospital LOS.  However, ventilator-free days were improved in the iNO group but was not statistically significant.   

Type: Clinical Science