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Open Access 01-05-2016 | Original Paper

Comparative assessment of the antirestenotic efficacy of two paclitaxel drug-eluting balloons with different coatings in the treatment of in-stent restenosis

Authors: Freek Nijhoff, Pieter R. Stella, Maartje S. Troost, Anouar Belkacemi, Hendrik M. Nathoe, Michiel Voskuil, Mariam Samim, Pieter A. Doevendans, Pierfrancesco Agostoni

Published in: Clinical Research in Cardiology | Issue 5/2016

Abstract

Background/objectives

Preclinical investigations have suggested that coating technology is crucial for the efficacy of drug-eluting balloons (DEB). Aim of this study is to compare the antirestenotic efficacy of two paclitaxel DEB with different coatings in the treatment of in-stent restenosis (ISR) by means of a morphological and functional assessment.

Methods

In a single center, prospective, non-randomized study, the shellac-paclitaxel coated DIOR, and the urea-paclitaxel coated IN.PACT Falcon were compared in the setting of ISR. Quantitative angiography, fractional flow reserve (FFR), and optical coherence tomography (OCT) were performed at baseline, postprocedure and 6-month follow-up. Main endpoints were QCA, FFR and OCT-based parameters of restenosis.

Results

Forty-five patients were included, 20 (44 %) received treatment with the DIOR and 25 (56 %) with the IN.PACT Falcon. Angiographic and device success were 100 and 90 % for the DIOR, and 100 and 92 % for the IN.PACT Falcon, respectively. After 6-months, in-segment late lumen loss (−0.03 ± 0.43 vs. 0.36 ± 0.48 mm, p = 0.014) and diameter stenosis (30.7 ± 16.2 vs. 41.3 ± 22.6 %, p = 0.083) were lower for the IN.PACT Falcon. FFR distal of the stent was significantly higher in the IN.PACT Falcon group (0.92 ± 0.07 vs. 0.84 ± 0.13, p = 0.029) and in-stent FFR gradient was lower (0.05 ± 0.05 vs. 0.13 ± 0.12, p = 0.002). Between postprocedure and follow-up, a 16 % decrease in neointimal volume was observed for the IN.PACT Falcon, while a 30 % increase was observed for the DIOR (p = 0.006).

Conclusions

The IN.PACT Falcon DEB showed higher antirestenotic efficacy than the DIOR in the treatment of ISR, demonstrating that DEB with an excipient-based coating is not equally effective.

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Title: Comparative assessment of the antirestenotic efficacy of two paclitaxel drug-eluting balloons with different coatings in the treatment of in-stent restenosis
Authors: Freek Nijhoff
Pieter R. Stella
Maartje S. Troost
Anouar Belkacemi
Hendrik M. Nathoe
Michiel Voskuil
Mariam Samim
Pieter A. Doevendans
Pierfrancesco Agostoni
Publication date: 01-05-2016
Publisher: Springer Berlin Heidelberg
Published in: Clinical Research in Cardiology / Issue 5/2016
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-015-0934-0

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Background/objectives

Methods

Results

Conclusions

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