Phase III multicenter trial comparing the efficacy of 2% dodecafluoropentane emulsion (EchoGen) and sonicated 5% human albumin (Albunex) as ultrasound contrast agents in patients with suboptimal echocardiograms
Year: 1998
Type: article
Abstract: OBJECTIVES: This study was performed to compare the safety and efficacy of intravenous 2% dodecafluoropentane (DDFP) emulsion (EchoGen) with that of active control (sonicated human albumin [Albunex]) for left ventricular (LV) cavity opacification in adult patients with a suboptimal echocardiogram. BACKGROUND: The development of new fluorocarbon-based echocardiographic contrast agents such as DDFP has allowed opacification of the left ventricle after peripheral venous injection. We hypothesized that DDFP was clinically superior to the Food and Drug Administration-approved active control. METHODS: This was a Phase III, multicenter, single-blind, active controlled trial. Sequential intravenous injections of active control and DDFP were given 30 min apart to 254 patients with a suboptimal echocardiogram, defined as one in which the endocardial borders were not visible in at least two segments in either the apical two- or four-chamber views. Studies were interpreted in blinded manner by two readers and the investigators. RESULTS: Full or intermediate 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 cavity 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 in 88% of patients versus 45% with active control (p < 0.001). Similar improvement was seen for duration of contrast effect, salvage of suboptimal echocardiograms, diagnostic confidence and potential to affect patient management. There was no difference between agents in the number of patients with adverse events attributed to the test agent (9% for DDFP vs. 6% for active control, p = 0.92). CONCLUSIONS: This Phase III multicenter trial demonstrates that DDFP is superior to sonicated human albumin for LV cavity opacification, endocardial border definition, duration of effect, salvage of suboptimal echocardiograms, diagnostic confidence and potential to influence patient management. The two agents had similar safety profiles.
Authors: Paul A Grayburn, James L Weiss, Terrence C Hack, Elizabeth Klodas, Joel S Raichlen, Manni A Vannan, Allan L Klein, Dalane W Kitzman, Steven G Chrysant, Jerald L Cohen, David Abrahamson, Elyse Foster, Julio E Perez, Gerard P Aurigemma, Julio A Panza, Michael H Picard, Benjamin F Byrd, Douglas S Segar, Stuart A Jacobson, David J Sahn, Anthony N DeMaria
Institutions: The University of Texas Southwestern Medical Center, Johns Hopkins University, Thomas Jefferson University, Tufts University, Tufts Medical Center, Cleveland Clinic, Atrium Health Wake Forest Baptist, Wake Forest University, VA New Jersey Health Care System, East Orange VA Medical Center, Orange County Heart Institute and Research Center, University of California, San Francisco, Washington University in St. Louis, Washington University Medical Center, University of Massachusetts Chan Medical School, National Institutes of Health, Harvard University, Massachusetts General Hospital, Vanderbilt University, Indiana University Indianapolis, Indiana University – Purdue University Indianapolis, Oregon Health & Science University, University of Oregon, University of California San Diego
Language: English
Subfield: Radiology, Nuclear Medicine and Imaging
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $7,166
OpenAlex ID: W1993872066