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Drug Coated Balloon
 
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Pre-Clinicals and Proof of Concept

Drug-eluting balloon: Very short-term exposure and overlapping
Bodo Cremers1; Ulrich Speck2; Nicola Kaufels2; Dirk Mahnkopf3; Michael Kühler4; Michael Böhm1; Bruno Scheller1

1University of Saarland, Homburg/Saar, Department of Internal Medicine III, Germany; 2Humboldt University Berlin, Campus Charité Mitte, Department of Radiology, Germany; 3IMTM GmbH, Immune Technologies & Medicine, Rottmersleben, Germany; 4B. Braun Melsungen AG, Vascular Systems, Berlin, Germany

Published by: © 2009 Schattauer GmbH, Stuttgart

Drug-eluting balloons for percutaneous coronary interventions
Marco Zimarino; Raffaele De Caterina

Institute of Cardiology and Center of Excellence on Aging, “G. d’Annunzio” University, Chieti, Italy

Published by: © 2009 Schattauer GmbH, Stuttgart

Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media
Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O
Invest Radiol. 2004 Mar;39(3):182-6

Department of Radiology, Charité, Humboldt University, Berlin, Germany

RATIONALE AND OBJECTIVES: Paclitaxel added to angiographic contrast medium (CM) has been shown to inhibit restenosis in the porcine coronary overstretch model. This study determined early local tissue concentrations after the administration of different paclitaxel doses and preparations. MATERIALS AND METHODS: Fifteen pigs received 2 stents each in the left coronary artery. During and/or after the intervention, paclitaxel-containing CM or diluted Taxol was injected. Fifteen minutes after the last intracoronary injection, paclitaxel concentrations in the arterial wall and myocardium were measured by high-performance liquid chromatography. RESULTS: Mean paclitaxel concentrations in the left coronary arteries reached 3-10 microM. Higher volumes and higher paclitaxel concentrations resulted in higher tissue concentrations. Paclitaxel in CM was better tolerated and led to higher local concentrations than diluted Taxol. Low paclitaxel concentrations in the uninjected right coronary artery and in plasma indicate selectivity. CONCLUSION: When admixed to CM, paclitaxel results in local tissue concentrations proportional to the amount of the drug injected.

PMID: 15076010 [PubMed – indexed for MEDLINE]   

Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries
Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B
Radiology. 2006 Aug;240(2):411-8

Department of Radiology, Charité Humboldt-University Berlin, Schumannstr 20-21, D 10117 Berlin, Germany

PURPOSE: To compare the inhibition of neointimal proliferation by using non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. MATERIALS AND METHODS: Experiments were conducted with permission of the animal protection committee of the local government. Paclitaxel was either dissolved in a nonionic contrast medium or coated on balloons. Stents were crimped on the coated balloons. Effectiveness was tested in 22 pigs. Two coronary stents were placed in each pig, and slight overstretch was applied. The animals were treated as follows: group A (control group), uncoated balloons, bare stents, and "plain" contrast medium; group B, same treatment as group A, but with paclitaxel in the contrast medium; group C, paclitaxel-coated balloons, with premounted bare stents and plain contrast medium; and group D, sirolimus-eluting stents, noncoated balloons, and plain contrast medium. Stenosis was assessed 4 weeks later at angiography and histomorphometry. For exploratory purposes, continuous variables of quantitative coronary angiography and histomorphometry were compared by using analysis of variance. RESULTS: Results at follow-up angiography indicated a mean of 1.00 mm +/- 0.18 (standard deviation) lumen diameter loss in the control group and 0.14 mm +/- 0.18 loss in the group treated with the paclitaxel-coated balloon (group C; P < .001). Findings at histomorphometry confirmed the effectiveness of drug delivery, with the most impressive inhibition of neointimal proliferation from coated balloons-the neointimal area was 2.4 mm2 +/- 0.3 (P < .01 vs all other groups), compared with 5.2 mm2 +/- 0.3 in group A (control group), 4.3 mm2 +/- 0.3 in group B, and 3.8 mm2 +/- 0.3 in group D. CONCLUSION: In spite of the short intima contact time, paclitaxel coated on the balloon inhibits neointimal formation in the porcine model of coronary stent placement. RSNA, 2006

PMID: 16864669 [PubMed – indexed for MEDLINE]   

Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis
Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm M, Nickenig G

Department of Internal Medicine III-Cardiology/Angiology, University of Saarland, Homburg/Saar, Germany

BACKGROUND: Drug-eluting stents have shown promising antirestenotic effects in clinical trials. Non-stent-based local delivery of antiproliferative drugs may offer additional flexibility and also reach vessel areas beyond the immediate stent coverage. The aim of the present study was to evaluate a novel method of local drug delivery based on angioplasty balloons. METHODS AND RESULTS: Stainless steel stents (n=40; diameter, 3.0 to 3.5 mm; length, 18 mm) were implanted in the left anterior descending and circumflex coronary arteries of domestic pigs. Both conventional uncoated and 3 different types of paclitaxel-coated, percutaneous transluminal coronary angioplasty balloons (contact with vessel wall for 1 minute) were used. No difference in short-term tolerance between coated and uncoated balloons and no signs of thrombotic events were observed. Quantitative angiography and histomorphometry of the stented arteries asserted the statistical equality of the baseline parameters between the control and the 3 treatment groups. Paclitaxel balloon coating led to a marked, dose-dependent reduction of parameters characterizing in-stent restenosis (reduction of neointimal area up to 63%). Despite the marked reduction in neointimal proliferation, endothelialization of stent struts was present in all samples. There was no evidence of a significant inflammatory response in the neighborhood of the stent struts. CONCLUSIONS: Paclitaxel balloon coating is safe, and it effectively inhibits restenosis after coronary angioplasty with stent implantation in the porcine model. The degree of reduction in neointimal formation was comparable to that achieved with drug-eluting stents.

PMID: 15302790 [PubMed – indexed for MEDLINE]