TY - JOUR
T1 - Poloxamer-188 as an adjunct to primary percutaneous transluminal coronary angioplasty for acute myocardial infarction
AU - O'Keefe, James H.
AU - Grines, Cindy L.
AU - DeWood, Marcus A.
AU - Schaer, Gary L.
AU - Browne, Kevin
AU - Magorien, Raymond D.
AU - Kalbfleisch, John M.
AU - Fletcher, William O.
AU - Bateman, Timothy M.
AU - Gibbons, Raymond J.
N1 - Funding Information:
From the Mid America Heart Institute, St. Luke’s Hospital, University of Missouri-Kansas City, Kansas City, Missouri; William-Beaumont Hospital, Royal Oak, Michigan; Sacred Heart Medical Center, Spokane, Washington; Rush-Presbyterian-St. Luke’s Medical Center, Chicago, Illinois; Lakeland Reglonal Medical Center, Lakeland, Florida; Ohio State University Hospital, Columbus, Ohio; St. Francis Hospital, Tulsa, Oklahoma; Appleton Medical Center, Appleton, Wisconsin; Mayo Clinic, Rochester, Minnesota. Supported in part by a research grant from Glaxo Wellcome, Inc., Research Triangle Park, North Carolina. Manuscript received February 15, 1996; revised manuscript received and accepted April 22, 1996.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 1996
Y1 - 1996
N2 - 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.
AB - 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.
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U2 - 10.1016/S0002-9149(96)00414-6
DO - 10.1016/S0002-9149(96)00414-6
M3 - Article
C2 - 8857476
AN - SCOPUS:10644250940
SN - 0002-9149
VL - 78
SP - 747
EP - 750
JO - American Journal of Cardiology
JF - American Journal of Cardiology
IS - 7
ER -