THROMBOLYTIC THERAPY OF PERIPHERAL ARTERIAL-OCCLUSION WITH RECOMBINANT STAPHYLOKINASE

Background Recombinant staphylokinase (STAR) induces fibrin-specific c oronary artery recanalization in patients with evolving myocardial inf arction. The present pilot study evaluates its thrombolytic efficacy, safety, fibrin specificity, and immunogenicity in patients with periph eral arterial occlusive disease.Methods and Results Thirty patients (3 7 to 86 years of age) with angiographically documented thromboembolic peripheral arterial occlusion of recent origin (21+/-5.5 days, mean+/- SEM) were treated with heparin and intra-arterial STAR given as a 1-mg bolus followed by a 0.5-mg/h infusion in 20 patients or as a 2-mg bol us followed by a 1-mg/h infusion in 10 subsequent patients. With 7.0+/ -0.7 mg STAR infused over 8.7+/-1.0 hours, recanalization was complete in 25 patients, partial in 2, and absent in 3. Two major hemorrhagic complications occurred: one fatal hemorrhagic stroke and one hypovolem ic shock caused by bleeding at the angiographic puncture site. Adminis tration of STAR did not induce fibrinogen breakdown or a significant p rolongation of template bleeding time. STAR-neutralizing activity and anti-STAR IgG were low at baseline, increased markedly from the second week on, and remained elevated for several months. Conclusions Intra- arterial administration of STAR restores vessel patency in patients wi th peripheral arterial occlusion in the absence of fibrinogen degradat ion.