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Thrombolytic therapy of peripheral arterial occlusion with recombinant staphylokinase
S Vanderschueren1, L Stockx, G Wilms
1Center for Molecular and Vascular Biology, University of 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.
Insights
Recombinant staphylokinase (STAR) effectively restores vessel patency in peripheral arterial occlusion. This pilot study shows STAR
Area of Science:
- Cardiovascular Research
- Thrombolytic Therapy
- Vascular Medicine
Background:
- Recombinant staphylokinase (STAR) is known for fibrin-specific coronary artery recanalization.
- Its efficacy and safety in peripheral arterial occlusive disease (PAOD) require evaluation.
Purpose of the Study:
- To assess the thrombolytic efficacy of intra-arterial STAR in patients with PAOD.
- To evaluate the safety, fibrin specificity, and immunogenicity of STAR in this patient group.
Main Methods:
- A pilot study involving 30 patients with recent peripheral arterial occlusion.
- Intra-arterial STAR administration with varying bolus and infusion rates, alongside heparin.
- Monitoring for recanalization, bleeding complications, fibrinogen levels, bleeding time, and immune response.
Main Results:
- Successful recanalization in 27 out of 30 patients (25 complete, 2 partial).
- Two major hemorrhagic complications: fatal stroke and bleeding at puncture site.
- No significant fibrinogen breakdown or prolonged bleeding time observed.
- Marked increase in STAR-neutralizing activity and anti-STAR IgG from week two onwards.
Conclusions:
- Intra-arterial STAR effectively restores vessel patency in peripheral arterial occlusion.
- STAR administration in PAOD occurs without inducing fibrinogen degradation.
- The immunogenic response to STAR is significant and sustained post-treatment.