POLOXAMER-188 AS AN ADJUNCT TO PRIMARY PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY FOR ACUTE MYOCARDIAL-INFARCTION

Poloxamer-188 is a surfactant polymer with antithrombotic and hemorheo logic properties that make it potentially useful as an adjunct to acut e reperfusion strategies. Animal studies and early human studies have documented poloxamer-188 to be effective at improving myocardial salva ge when used as an adjunct to intravenous thrombolytic therapy for acu te myocardial infarction, The current trial was a prospective pilot st udy involving 150 patients who were randomized in a 2:1 fashion to a p oloxamer-188 infusion for 48-hours versus placebo, The poloxamer-188 i nfusion was well tolerated subjectively, The only clinically significa nt laboratory abnormality noted was an elevation in the serum creatini ne above 2.0 g/dl in 12% (n = 12) of the 98 poloxamer-188 treated pati ents versus 1 of the 52 (2%) of the placebo treated patients (p = 0.04 8), 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 qua ntitative nuclear techniques, final infarct size and myocardial salvag e 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 pla cebo group (p = NS), Final infarct size, was not altered by the poloxa mer-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 myoc ardial infarction and resulted in azotemia in 12% of the patients.