High-dose intravenous isosorbide-dinitrate is safer and better than Bi-PAPventilation combined with conventional treatment for severe pulmonary edema

OBJECTIVES To determine the feasibility, safety and efficacy of bilevel pos itive airway ventilation (BiPAP) in the treatment of severe pulmonary edema compared to high dose nitrate therapy. BACKGROUND Although noninvasive ventilation is increasingly used in the tre atment of pulmonary edema, its efficacy has not been compared prospectively with newer treatment modalities. METHODS We enrolled 40 consecutive patients with severe pulmonary edema (ox ygen saturation <90% on room air prior to treatment). All patients received oxygen at a rate of 10 liter/min, intravenous (IV) furosemide 80 mg and IV morphine 3 mg. Thereafter patients were randomly allocated to receive 1) r epeated boluses of IV isosorbide-dinitrate (ISDN) 4 mg every 4 min (n = 20) , and 2) BiPAP ventilation and standard dose nitrate therapy (n = 20). Trea tment was administered until oxygen saturation increased above 96% or systo lic blood pressure decreased to below 110 mm Hg or by more than 30%. Patien ts whose conditions deteriorated despite therapy were intubated and mechani cally ventilated. All treatment was delivered by mobile intensive care unit s prior to hospital arrival. RESULTS Patients treated by BiPAP had significantly more adverse events. Tw o BiPAP treated patients died versus zero in the high dose ISDN group. Sixt een BiPAP treated patients (80%) required intubation and mechanical ventila tion compared to four (20%) in the high dose ISDN group (p = 0.0004). Myoca rdial infarction (MI) occurred in 11 (55%) and 2 (10%) patients, respective ly (p = 0.006). The combined primary end point (death, mechanical ventilati on or hi) was observed in 17 (85%) versus 5 (25%) patients, respectively (p = 0.0003). After 1 h of. treatment, oxygen saturation increased to 96 +/- 4% in the high dose ISDN group as compared to 89 +/- 7% in the BiPAP group (p = 0.017). Due to the significant deterioration observed in patients enro lled in the BiPAP arm, the study was prematurely terminated by the safety c ommittee. CONCLUSIONS High dose ISDN is safer and better than BiPAP ventilation combi ned with conventional therapy in patients with severe pulmonary edema. (C) 2000 by the American College of Cardiology.