Comparative assessment of drug-eluting balloons in an advanced porcine model of coronary restenosis

Michael Joner; Robert A. Byrne; Jean-Martin Lapointe; Peter W. Radke; Gerd Bayer; Kristin Steigerwald; Eric Wittchow

doi:10.1160/TH10-11-0698

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2011; 105(05): 864-872
DOI: 10.1160/TH10-11-0698

Animal Models

Schattauer GmbH

Comparative assessment of drug-eluting balloons in an advanced porcine model of coronary restenosis

Authors

Michael Joner

¹Deutsches Herzzentrum München, Munich, Germany
Robert A. Byrne

¹Deutsches Herzzentrum München, Munich, Germany
Jean-Martin Lapointe

²AccelLAB Inc, Boisbriand, Quebec, Canada
Peter W. Radke

⁴Universitätsklinik Schleswig- Holstein, Campus Lübeck, Lübeck, Germany
Gerd Bayer

³Biotronik SE & Co.KG, Berlin-Neukölln, Germany
Kristin Steigerwald

¹Deutsches Herzzentrum München, Munich, Germany
Eric Wittchow

³Biotronik SE & Co.KG, Berlin-Neukölln, Germany

Abstract

Summary

The advent of drug-eluting balloon (DEB) therapy has represented an important development in interventional cardiology. Nevertheless, pre-clinical data with this technology remain scant, and comparative studies have not previously been published. Bare metal stents were implanted in the coronary arteries of 15 pigs followed by balloon angioplasty. Animals were allocated to treatment with a 60-second inflation of one of four different balloon catheters: a conventional untreated plain angioplasty balloon (PBA, Biotronik AG), the Pantera Lux DEB (3.0 μg/mm² paclitaxel; BTHC excipient, Biotronik AG), the Elutax DEB (2.0 μg/mm² paclitaxel; no excipient; Aachen Resonance), or the SeQuent Please DEB (3.0 μg/mm² paclitaxel; iopromide excipient: B. Braun). Twenty-eight days following balloon deployment, animals underwent repeat angiography for quantitative coronary angiography analysis and euthanasia for histopathologic assessment. By histology, the mean neointimal thickness was 0.44 ± 0.19 mm with PBA, 0.35 ± 0.13 mm with Pantera Lux, 0.61 ± 0.20 mm with Elutax, and 0.47 ± 0.21 mm with SeQuent Please DEB (p=0.02). In comparison with PBA, deployment of the Pantera Lux or the SeQuent Please DEB resulted in delayed healing characterised by significant increases in fibrin, neointimal cell vacuity and delayed re-endothelialisation. In conclusion, investigation of comparative DEB performance in a porcine model of advanced coronary restenosis reveals significant heterogeneity of neointimal suppression between the devices tested with numerically lowest values seen in the Pantera Lux group. On the other hand, evidence of delayed healing was observed in the most effective DEB groups.

Keywords

Porcine model - drug-eluting balloon - restenosis

Full Text

References

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