Abstract

Four hundred seventy-three patients with acute myocardial infarction (AMI) were treated with either saruplase (80 mg/hour, n = 236) or alteplase (100 mg every 3 hours, n = 237). Comedication included heparin and acetylsalicylic acid. Angiography was performed at 45 and 60 minutes after the start of thrombolytic therapy. When flow was insufficient, angiography was repeated at 90 minutes. Coronary angioplasty was then performed if Thrombolysis In Myocardial Infarction (TIMI) trial 0 to 1 flow was seen. Control angiography was at 24 to 40 hours. Baseline characteristics were similar. Angiography showed comparable and remarkably high early patency rates (TIMI 2 or 3 flow) in both treatment groups: at 45 minutes, 74.6% versus 68.9% (p = 0.22); and at 60 minutes 79.9% versus 75.3% (p = 0.26). Patency rates at 90 minutes before additional interventions were also comparable (79.9% and 81.4%). Angiographic reocclusion rates were not significantly different: 1.2% versus 2.4% (p = 0.68). After rescue angioplasty, angiographic reocclusion rates of 22.0% and 15.0% were observed. Safety data were similar for both groups. Thus, (1) early patency rates were high for saruplase and alteplase treatment, (2) reocclusion rates for both drugs were remarkably low, and (3) complication rates were similar. Thus, saruplase seems to be as safe and effective as alteplase.In the SESAM trial, saruplase or alteplase was given to 473 patients with acute myocardial infarction. Angiography at 45 minutes already showed high patency rates (Thrombolysis in Myocardial Infarction trial 2 or 3 flow) with saruplase and alteplase of 74.6% and 68.9%, at 60 minutes 79.9% and 75.3%, and at 90 minutes (before intervention) 79.9% and 81.4%, respectively. Angiographic reocclusion rates at 24 to 40 hours were low: 1.2% and 2.4% (p = 0.68). Safety data were comparable. Thus, both saruplase and alteplase treatment resulted in high, early patency, and low reocclusion rates.

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