Catheter-directed thrombolysis with microplasmin for acute peripheral arterial occlusion (PAO): an exploratory study.

Abstract

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.

• Authors: P Verhamme, S Heye, K Peerlinck, G Cahillane, M Tangelder, I Fourneau, K Daenens, A Belmans, S Pakola, R Verhaeghe, G Maleux
• Journal: International angiology : a journal of the International Union of Angiology (Int Angiol) Vol. 31 Issue 3 Pg. 289-96 (Jun 2012) ISSN: 1827-1839 [Electronic] Italy
• PMID: 22634985 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Peptide Fragments
• microplasmin
• Fibrinolysin

Topics

• Acute Disease
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Arterial Occlusive Diseases (drug therapy)
• Catheters
• Female
• Fibrinolysin (administration & dosage)
• Humans
• Male
• Middle Aged
• Peptide Fragments (administration & dosage)
• Peripheral Arterial Disease (drug therapy)
• Pilot Projects
• Thrombolytic Therapy (methods)
• Young Adult