Circulation, Vol 90, 114-120, Copyright © 1994 by American Heart Association
TC Wall, RM Califf, J Blankenship, JD Talley, M Tannenbaum, M Schwaiger, G Gacioch, MD Cohen, M Sanz and JD Leimberger
BACKGROUND: This study was performed to determine the safety and potential
efficacy of an intravenous perfluorochemical emulsion (Fluosol) as an
adjunct reperfusion therapy aimed at preventing reperfusion injury for
patients with acute myocardial infarction. METHODS AND RESULTS: Patients
(430) were randomized in a prospective open-labeled study, 213 to receive
Fluosol and 217 to receive no Fluosol, along with 100 mg of tissue-type
plasminogen activator given over 3 hours. Major end points included global
ejection fraction, regional wall motion analysis, infarct size as measured
by tomographic thallium imaging, and a composite clinical outcome measure.
Baseline patient and angiographic characteristics were similar in the two
groups. No significant difference in global ejection fraction (52% without
Fluosol, 51% with Fluosol) or regional wall motion (-2.4 SD/chord with
Fluosol, -2.2 SD/chord without Fluosol) was demonstrated in patients
receiving Fluosol versus those not receiving Fluosol, nor was there a
significant difference in thallium infarct size. Although Fluosol-treated
patients with anterior infarction had an insignificantly lower mean infarct
size (18.7% of the left ventricle) compared with patients with anterior
infarction not treated with Fluosol (21.2% of left ventricle), this trend
was not evident in the median infarct size values (22% versus 17%), left
ventricular ejection fraction values (46% without Fluosol, 47% with
Fluosol), or regional wall motion (-2.5 SD/chord in both groups). Rates of
death and stroke were no different in the two groups; however, patients who
received Fluosol experienced less recurrent ischemia. Patients receiving
intravenous Fluosol had more transient congestive heart failure and
pulmonary edema, perhaps because of necessary fluid administration. There
was no difference in hemorrhagic complications between the two study
groups. CONCLUSIONS: When given with a thrombolytic agent, Fluosol was not
associated with improvement in ventricular systolic function, reduction in
thallium infarct size, or overall clinical outcome. Fluosol was, however,
associated with a reduction in ischemic complications and with an increase
in pulmonary edema and congestive heart failure.
ARTICLES
Intravenous Fluosol in the treatment of acute myocardial infarction. Results of the Thrombolysis and Angioplasty in Myocardial Infarction 9 Trial. TAMI 9 Research Group
Duke University Medical Center, Durham, NC 27710.
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