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Official Journal of the , the International Union of Phlebology and the
Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 0,899
Online ISSN 1827-1839
Verhamme P. 1, 2, Heye S. 3, Peerlinck K. 1, 2, Cahillane G. 4, Tangelder M. 4, 5, Fourneau I. 6, Daenens K. 6, Belmans A. 7, Pakola S. 4,Verhaeghe R. 1, Maleux G. 3
1 Department of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium;
2 Center for Molecular and Vascular Biology, University of Leuven, Leuven, Belgium;
3 Department of Radiology, University Hospitals Leuven, Leuven, Belgium;
4 Clinical Development, ThromboGenics NV, Leuven, Belgium;
5 Department of Vascular Surgery, University Medical Center Utrecht, the Netherlands;
6 Department of Vascular Surgery, University Hospitals Leuven, Leuven, Belgium;
7 Leuven Biostatistics and Statistical Bioinformatics Centre, University of Leuven, Leuven, Belgium
AIM: We performed an open-label, dose-ascending, single-centre, Phase IIa study to explore the safety and efficacy of catheter-directed thrombolysis (CDT) with microplasmin for infrainguinal arterial or bypass occlusions.
METHODS: Patients who presented with acute occlusions were subsequently treated with an intrathrombus infusion of five ascending doses of microplasmin: 0.3 mg/kg/h for 4 hours; 0.45 mg/kg/h for 4 hours; 0.6 mg/kg/h for 4 hours; 0.9 mg/kg/h for 4 hours or 0.6 mg/kg/h for 6 hours. Repeat angiograms were obtained to assess the degree of clot lysis. The primary outcome was complete thrombolysis defined as >95% thrombus volume reduction at the end of the microplasmin infusion. Safety evaluation included bleedings, adverse events and coagulation biomarkers.
RESULTS: Complete thrombolysis was obtained in 3 of the 19 treated patients at the end of microplasmin infusion. Thrombus volume reduction between 50% and 95% was achieved with all dosing regimens. Clinically significant distal embolization occurred in 8 patients. One major and two non-major bleedings occurred. Microplasmin depleted α2-anti-plasmin and decreased fibrinogen.
CONCLUSION: Intrathrombus infusion of microplasmin for 4 or 6 hours resulted in significant clot lysis. Distal embolization appeared the most important limitation.