A pilot study on bolus administration of recombinant staphylokinase for coronary artery thrombolysis

Recombinant staphylokinase (Sak) is a highly fibrin-specific thrombolytic agent but the optimal dose and mode of administration remain to be defined. Intravenous (i.v.) infusion over 5 min of 20 mg Sak in 12 patients with acute myocardial infarction induced complete coronary patency (TIMI perfusion grade 3) in 7 patients (58%) within 60 min. In 3 of the 5 patients with no or suboptimal flow (TIMI grade 0, 1 or 2) at 60 min, an additional 10 mg i.v. bolus of Sak resulted in TIMI grade 3 flow at 90 min. No major treatment-related complication occurred. Residual fibrinogen and alpha 2-antiplasmin levels at 90 min were 110 +/- 6.0% and 98 +/- 4.1% (mean +/- SEM) of baseline, respectively. Median antibody-related Sak-neutralizing activity was low at baseline (0.0 microgram/ml) and after 1 week (0.5 microgram/ml) but increased from day 10 on (to 4.0 micrograms/ml). Thus, bolus thrombolysis with Sak may induce efficient coronary artery recanalization while preserving circulating fibrinogen and alpha 2-antiplasmin. Comparative trials of coronary thrombolysis with double-bolus Sak appear to be warranted.