APSAC VERSUS PLACEBO: THE FIRST PLACEBO CONTROLLED CORONARY RECANALISATION STUDY WITH PRE AND POST TREATMENTCORONARY ARTERIOGRAPHY

Abstract

40 patients entered the first double-blind placebo controlled invasive arteriographic study of intravenous anisoylated plasminogen streptokinase activator complex (APSAC) for coronary recanalisation in acute myocardial infarction. Coronary arteriography was performed before and 90 minutes after a single intravenous injection of APSAC or matched placebo given over 2-5 minutes. Pre-treatment coronary arteriography was performed in all 40 patients 3.1 ± 1.2 hours after the onset of major symptoms of myocardial infarction. All coronary arteriograms were read blindly and scored according to the TIMI criteria by an independent cardiologist. Following randomisation occlusion of the infarct related coronary artery was demonstrable in 29 of the 40 cases at pre-treatment coronary arteriography. Patients were given either APSAC 30 units (n=l6) or matched placebo (n=13),3.3 ± 1.3 hours after the onset ofsymptoms. Repeat coronary arteriography was performed 90 minutes after administration of study drug. 9 of the 16 patients who received APSAC had demonstrable coronary recanalisation of the infarct related vessel compared with only one patient inthe placebo group (P 0.05).A third full diagnostic coronary arteriogram was performed three days after treatment and this showed persistent patency of all the recanalised coronary arteries except one in the APSAC group as well as late recanalisation in a further 4 cases, 3 of whom had received APSAC.Of the 11 patients who had patent infarctrelated arteries on initial arteriography, 4 received APSAC and 7 placebo. Patency was maintained in all these throughout the study period.There were haemorrhagic complications related to APSAC therapy. This data confirms the thrombolytic efficacy of APSAC in acute myocardial infarction, and indicates that the drug may be used safely by the intravenous route with a 56 per cent recanalisation rate at 90 minutes. Re-occlusion of the recanalised vessel was rare.