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05.11.2015 | Original Paper | Ausgabe 5/2016 Open Access

Clinical Research in Cardiology 5/2016

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

Zeitschrift:
Clinical Research in Cardiology > Ausgabe 5/2016
Autoren:
Freek Nijhoff, Pieter R. Stella, Maartje S. Troost, Anouar Belkacemi, Hendrik M. Nathoe, Michiel Voskuil, Mariam Samim, Pieter A. Doevendans, Pierfrancesco Agostoni
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1007/​s00392-015-0934-0) contains supplementary material, which is available to authorized users.

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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Zusatzmaterial
Supplementary material 1 (PDF 221 kb)
392_2015_934_MOESM1_ESM.pdf
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