A RANDOMIZED TRIAL OF RECOMBINANT STAPHYLOKINASE VERSUS ALTEPLASE FORCORONARY-ARTERY PATENCY IN ACUTE MYOCARDIAL-INFARCTION

Background Recombinant staphylokinase (STAR) was shown recently to off er promise for coronary arterial thrombolysis in patients with evolvin g myocardial infarction. The present multicenter randomized open trial was designed to assess the thrombolytic efficacy, safety, and fibrin specificity of STAR relative to accelerated alteplase (recombinant tis sue-type plasminogen activator [RTPA]). Methods and Results One hundre d patients with evolving myocardial infarction of <6 hours' duration a nd with ST-segment elevation were allocated to accelerated and weight- adjusted RTPA over 90 minutes (52 patients) or to STAR (the first 25 p atients to 10 mg and the next 23 patients to 20 mg given intravenously over 30 minutes). All patients received aspirin and intravenous hepar in. The main end points were coronary artery patency and plasma fibrin ogen levels at 90 minutes. Thrombolysis in Myocardial Infarction (TIMI ) perfusion grade 3 at 90 minutes was achieved in 62% of STAR patients versus 58% of RTPA patients (risk ratio, 1.1; 95% CI, 0.76 to 1.5). W ith 10 mg STAR, TIMI grade 3 patency was 50% (risk ratio, 0.86; 95% CI , 0.54 to 1.4 versus RTPA); with 20 mg STAR, it was 74% (risk ratio, 1 .3; 95% CI, 0.90 to 1.8 versus RTPA). Residual fibrinogen levels at 90 minutes were 118+/-47% (mean+/-SD) of baseline with STAR and 68+/-42% with RTPA (P<.0005). STAR therapy was not associated with an excess m ortality or electric, hemorrhagic, mechanical, or allergic complicatio ns. However, patients developed antibody-mediated STAR-neutralizing ac tivity from the second week after STAR treatment. As an addendum to th e randomized study, 5 patients were given 40 mg STAR over 30 minutes, resulting in TIMI perfusion grade 3 at 90 minutes in 4 patients withou t fibrinogen breakdown (residual levels at 90 minutes of 105+/-8% of b aseline). Conclusions STAR appears to be at least as effective for ear ly coronary recanalization as and significantly more fibrin-specific t han accelerated RTPA in patients with evolving myocardial infarction.