RANDOMIZED, DOUBLE-BLIND-STUDY COMPARING SARUPLASE WITH STREPTOKINASETHERAPY IN ACUTE MYOCARDIAL-INFARCTION - THE COMPASS EQUIVALENCE TRIAL

Objectives. This study sought to demonstrate the equivalence of sarupl ase and streptokinase in terms of 30-day mortality. Background. The us e of thrombolytic agents in the treatment of acute myocardial infarcti on is well established and has been shown to substantially reduce post -myocardial infarction mortality. Methods. Three thousand eighty nine patients with symptoms compatible with those of acute myocardial infar ction for <6 h entered the study at a total of 104 centers and were ra ndomized to receive streptokinase (1.5-MU infusion over 60 min) or sar uplase (20-mg bolus and 60-mg infusion over 60 min). In the saruplase group, a bolus of heparin (5,000 IU) was administered before saruplase , and a corresponding blinded double-dummy placebo bolus was administe red before streptokinase. All patients received intravenous heparin in fusions for greater than or equal to 24 h starting 30 min after the en d of the thrombolytic infusions; the infusions were titrated to mainta in an activated partial thromboplastin time at 1.5 to 2.5 times that o f normal. Results. Death of any cause up to 30 days after randomizatio n occurred in 88 (5.7%) of 1,542 patients randomized to receive sarupl ase and 104 (6.7%) of 1,547 patients randomized to receive streptokina se (odds ratio 0.84, p < 0.01 for equivalence). Hemorrhagic strokes oc curred more often in patients receiving saruplase (0.9% vs. 0.3%), whe reas thromboembolic strokes were more prevalent in the streptokinase-t reated patients (0.5% vs. 1.0%). The rate of bleeding was similar in t he two treatment groups (10.4% vs. 10.9%). Hypotension and cardiogenic shock occurred less frequently in the saruplase group. Reinfarction r ates were similar. Conclusions. Saruplase is a clinically safe and eff ective thrombolytic medication. This profile ranks saruplase favorably among the currently available thrombolytic agents. (C) 1998 by the Am erican College of Cardiology.