Poloxamer-188 as an adjunct to primary percutaneous transluminal coronary angioplasty for acute myocardial infarction.
Poloxamer-188 is a surfactant polymer with antithrombotic and hemorheologic properties that make it potentially useful as an adjunct to acute reperfusion strategies. Animal studies and early human studies have documented poloxamer-188 to be effective at improving myocardial salvage when used as an adjunct to intravenous thrombolytic therapy for acute myocardial infarction. The current trial was a prospective pilot study involving 150 patients who were randomized in a 2:1 fashion to a poloxamer-188 infusion for 48-hours versus placebo. The poloxamer-188 infusion was well tolerated subjectively. The only clinically significant laboratory abnormality noted was an elevation in the serum creatinine above 2.0 g/dl in 12% (n = 12) of the 98 poloxamer-188 treated patients versus 1 of the 52 (2%) of the placebo treated patients (p = 0.048). Clinical end points including reinfarction (1% vs 4%), cardiogenic shock (7% vs 6%), and death (9% vs 4%) were statistically similar in the poloxamer-188 and placebo groups, respectively (p = NS). Using quantitative nuclear techniques, final infarct size and myocardial salvage were statistically similar in the poloxamer-188 and placebo groups. Mean left ventricular ejection fractions 1 week post after infarction were 51% +/- 12% in the poloxamer-188 group and 52% +/- 13% in the placebo group (p = NS). Final infarct size, was not altered by the poloxamer- 188 infusion; however, it was significantly correlated with normal perfusion (Thrombolysis in Myocardial Infarction grade 3 flow) in the infarct vessel after angioplasty. This study documented poloxamer-188 to be ineffective as an adjunct to primary angioplasty for acute myocardial infarction and resulted in azotemia in 12% of the patients.
O'Keefe
J H
JH
Mid America Heart Institute, St. Luke's Hospital, University of Missouri-Kansas City, USA.
Grines
C L
CL
DeWood
M A
MA
Schaer
G L
GL
Browne
K
K
Magorien
R D
RD
Kalbfleisch
J M
JM
Fletcher
W O
WO
Bateman
T M
TM
Gibbons
R J
RJ
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000628:therapy*; D010865:Pilot Projects; D011060:Poloxalene / Q000008:administration & dosage*; D011446:Prospective Studies; D013501:Surface-Active Agents / Q000008:administration & dosage*; D016896:Treatment Outcome
D013501:Surface-Active Agents; D011060:Poloxalene; D003404:Creatinine