Drug-eluting balloon: Very short-term exposure and overlapping

Bodo Cremers; Ulrich Speck; Nicola Kaufels; Dirk Mahnkopf; Michael Kühler; Michael Böhm; Bruno Scheller

doi:10.1160/TH08-06-0387

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2009; 101(01): 201-206
DOI: 10.1160/TH08-06-0387

New Technologies, Diagnostic Tools and Drugs

Schattauer GmbH

Drug-eluting balloon: Very short-term exposure and overlapping

Bodo Cremers

¹University of Saarland, Homburg/Saar, Department of Internal Medicine III, Germany

,

Ulrich Speck

²Humboldt University Berlin, Campus Charité Mitte, Department of Radiology, Germany

,

Nicola Kaufels

²Humboldt University Berlin, Campus Charité Mitte, Department of Radiology, Germany

,

Dirk Mahnkopf

³IMTM GmbH, Immune Technologies & Medicine, Rottmersleben, Germany

,

Michael Kühler

⁴B. Braun Melsungen AG, Vascular Systems, Berlin, Germany

,

Michael Böhm

¹University of Saarland, Homburg/Saar, Department of Internal Medicine III, Germany

,

Bruno Scheller

¹University of Saarland, Homburg/Saar, Department of Internal Medicine III, Germany

› Author Affiliations

Abstract

Summary

Paclitaxel balloon coating has shown promising effects in inhibiting restenosis in initial clinical trials. The aim of the present study was to evaluate the influence of two critical features of drug-eluting balloon (DEB) application – inflation time and increased dose due to overlapping balloons. Fifty-six stainless steel stents were implanted in the left anterior descending and circumflex coronary arteries of 28 domestic pigs using a 1.2:1.0 overstretch ratio. Stents were mounted on conventional un-coated and paclitaxel-coated angioplasty balloon catheters. The animals were randomized to five different treatments with a range of short (10 seconds [s] inflation using 1 DEB) to extended (2x60 s inflation using 2 DEB) intima contact time. After 28 days, quantitative angiography and histomorphometry of the stented arteries was performed on a total of 23 pigs. Paclitaxel balloon coating led to a marked reduction of parameters characterizing in-stent stenosis: Late lumen loss was 1.37 ± 0.49 mm for uncoated balloons, 0.23 ± 0.42 mm for one coated balloon 60 s inflation time, 0.37 ± 0.28 mm for 10 s inflation time and 0.30 ± 0.19 mm for the vessel segment treated by two coated balloons with 60 s inflation each. Neointimal areas were 4.26 ± 1.18, 1.68 ± 0.23, 1.83 ± 0.40 and 1.67 ± 0.46 mm², respectively (p=0.001 versus control, p>0.05 between paclitaxel-treated groups). Despite the marked reduction of neointimal proliferation, endothelialization of stent struts was present in all samples. DEB were found to effectively reduce neointimal proliferation regardless of inflation time and dose within the tested range. No adverse reactions were seen as dose was increased to more than three times the clinically tested dose.

Keywords

Restenosis - drug-eluting balloon - inflation time - overlap - paclitaxel

Full Text

References

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