Antithrombogenic Coating of Stents Using a Biodegradable Drug Delivery Technology

R. Herrmann; G. Schmidmaier; B. Märkl; A. Resch; I. Hähnel; A. Stemberger; E. Alt

doi:10.1055/s-0037-1614629

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1999; 82(01): 51-57
DOI: 10.1055/s-0037-1614629

Rapid Communication

Schattauer GmbH

Antithrombogenic Coating of Stents Using a Biodegradable Drug Delivery Technology

R. Herrmann

²From the I. Medizinische Klinik, Technische Universität München, Munich, Germany

,

G. Schmidmaier

¹Inst. Exp. Onkologie und Therapieforschung, Klinikum rechts der Isar, Technische Universität München, Munich, Germany

,

B. Märkl

²From the I. Medizinische Klinik, Technische Universität München, Munich, Germany

,

A. Resch

²From the I. Medizinische Klinik, Technische Universität München, Munich, Germany

,

I. Hähnel

²From the I. Medizinische Klinik, Technische Universität München, Munich, Germany

,

A. Stemberger

¹Inst. Exp. Onkologie und Therapieforschung, Klinikum rechts der Isar, Technische Universität München, Munich, Germany

,

E. Alt

²From the I. Medizinische Klinik, Technische Universität München, Munich, Germany

› Author Affiliations

Abstract

Summary

To reduce the thrombogenic properties of coronary artery stents, a biodegradable polylactic acid (PLA) stent coating with an incorporated thrombin inhibitor and a platelet aggregation inhibitor has been developed. In an ex vivo human stasis model, its effect on platelets, plasmatic coagulation and its release characteristics were studied using whole blood. Bare steel and bare gold-surface stents were compared to steel and gold-surface stents coated with PLA (30 kDa) containing 5% polyethyleneglycol (PEG)-hirudin and 1% iloprost, with an empty tube as control. Markers of activated coagulation (prothrombin fragment F_1-2 and thrombin-antithrombin III complex, TAT), were assayed and the release of drugs from the coating was assessed by aPTT and collagen-induced platelet aggregation. Bare steel and gold stents were completely covered by a blood clot, and high levels of coagulation markers (F_1-2 fragment and TAT) were detected. No differences in the thrombogenic properties were found between bare gold or steel stents. Coated stents were free of blood clots and only minor elevations of markers were detected. Release data from in-vitro studies over 90 days showed a gradual release of the drugs with an initial exponential release characteristic for PEG-hirudin, slow release of iloprost and a 10% degradation of the PLA carrier. This drug releasing biodegradable coating effectively reduced thrombus formation independent of the metallic surface.

Full Text

References

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