PHASE-III MULTICENTER TRIAL COMPARING THE EFFICACY OF 2-PERCENT DODECAFLUOROPENTANE EMULSION (ECHOGEN) AND SONICATED 5-PERCENT HUMAN ALBUMIN (ALBUNEX) AS ULTRASOUND CONTRAST AGENTS IN PATIENTS WITH SUBOPTIMAL ECHOCARDIOGRAMS

Objectives. This study was performed to compare the safety and efficac y of intravenous 2% dadecafluoropentane (DDFP) emulsion (EchoGen) with that of active control (sonicated human albumin [Albunex]) for left v entricular (LV) cavity opacification in adult patients with a suboptim al echocardiogram. Background. The development of new fluorocarbon-bas ed echocardiographic contrast agents such as DDFP has allowed opacific ation of the left ventricle after peripheral venous injection. We hypo thesized that DDFP was clinically superior to the Food and Drug Admini stration-approved active control. Methods. This was a Phase III, multi center, single blind, active controlled trial. Sequential intravenous injections of active control and DDFP were given 30 min apart to 254 p atients with a suboptimal echocardiogram, defined as one in which the endocardial borders mere not visible in at least two segments in eithe r the apical two- or four-chamber views. Studies were interpreted in b linded manner by two readers and the investigators. Results. Full or i ntermediate LV cavity opacification was more frequently observed after DDFP than after active control (78% vs. 31% for reader A; 69% vs. 34% for reader B; 83% vs. 55% for the investigators, p < 0.0001). LV cavi ty opacification scores were higher with DDFP (2.0 to 2.5 vs. 1.1 to 1 .5, p < 0.0001). Endocardial border delineation was improved by DDFP i n 88% of patients versus 45% with active control (p < 0.001). Similar improvement was seen for duration of contrast effect, salvage of subop timal echocardiograms, diagnostic confidence and potential to affect p atient management. There was no difference between agents in the numbe r of patients with adverse events attributed to the test agent (9% for DDFP vs. 6% for active control, p = 0.92). Conclusions. This Phase il l multicenter trial demonstrates that DDFP is superior to sonicated hu man albumin for LV cavity opacification, endocardial border definition , duration of effect, salvage of suboptimal echocardiograms, diagnosti c confidence and potential to influence patient management. The two ag ents had similar safety profiles.