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(Circulation. 1995;92:2050-2057.)
© 1995 American Heart Association, Inc.

Articles

Thrombolytic Therapy of Peripheral Arterial Occlusion With Recombinant Staphylokinase

Steven Vanderschueren, MD; Luc Stockx, MD; Guy Wilms, MD, PhD; Hendrik Lacroix, MD; Raymond Verhaeghe, MD, PhD; Jozef Vermylen, MD, PhD; Désiré Collen, MD, PhD

From the Center for Molecular and Vascular Biology (S.V., R.V., J.V., D.C.) and the Departments of Radiology (L.S., G.W.) and Vascular Surgery (H.L.), University of Leuven (Belgium).

Correspondence to D. Collen, MD, PhD, Center for Molecular and Vascular Biology, University of Leuven, Campus Gasthuisberg, O&N, Herestraat 49, B-3000 Leuven, Belgium.

Background Recombinant staphylokinase (STAR) induces fibrin-specific coronary artery recanalization in patients with evolving myocardial infarction. The present pilot study evaluates its thrombolytic efficacy, safety, fibrin specificity, and immunogenicity in patients with peripheral arterial occlusive disease.

Methods and Results Thirty patients (37 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 bolus 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 hypovolemic shock caused by bleeding at the angiographic puncture site. Administration of STAR did not induce fibrinogen breakdown or a significant prolongation 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 with peripheral arterial occlusion in the absence of fibrinogen degradation.

Key Words: peripheral vascular disease • thrombolysis • plasminogen activators • staphylokinase

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