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Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty

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Abstract

Background

This study investigated p aclitaxel-induced luminal changes following drug-coated balloon (DCB) angioplasty to treat coronary de novo lesions without additional stenting. DCB-mediated local drug delivery reduces late lumen loss in de novo coronary artery lesions. We performed a retrospective clinical assessment based on a pre-specified quantitative coronary angiography (QCA) protocol.

Methods

QCA was performed for each centre to assess the primary endpoint late lumen changes, i.e. the difference between in-lesion minimal lumen diameter (MLD) at the routine angiographic follow-up as compared to post-procedural in-lesion MLDs. These MLD changes were compared to corresponding reference vessel diameter changes as an intra-patient control.

Results

We evaluated 58 consecutive native coronary artery lesions directly after DCB angioplasty and at a routine target follow-up angiography of 4 months by QCA. Target lesion MLD increased significantly within the 4.1 ± 2.1 month observation period (1.75 ± 0.55 vs. 1.91 ± 0.55 mm, p < 0.001, diameter stenosis 33.8 ± 12.3 vs. 26.9 ± 13.8 %, p < 0.001), while there were no changes in non-target reference vessel diameters (2.33 ± 0.60 vs. 2.34 ± 0.61 mm, p = ns). A total of 69 % of patients showed luminal enlargement whereas 29 % had minor luminal loss.

Conclusion

Local application of paclitaxel by DCB angioplasty to native coronary arteries after pre-dilatation without major dissection and recoil leads to late lumen increase.

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Conflict of interest

The authors declare the following conflicts of interest: Franz Kleber is a consultant to B. Braun and has received institutional grant support by Medtronic and B. Braun. Yvonne Clever and Telse Hausschild declared no potential conflict of interest. Antonia Schulz received travel expenses from B. Braun. Matthias Waliszweski is a full-time employee at the Medical Scientific Affairs department of B. Braun Vascular Systems. Michael Böhm and Ulrich Dietz declared no conflict of interest. Bruno Scheller is a consultant to B. Braun and received institutional grants and lecture fees from B. Braun as well as travel expenses from Medtronic and B. Braun. Bodo Cremers received lecture fees from Medtronic and B. Braun as well as travel expenses from Medtronic and B. Braun. This is an investigator-driven study. Relative to this clinical assessment there was no funding provided from any public, commercial or not-for-profit sectors.

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Authors and Affiliations

  1. Cardio Centrum Berlin, Academic Teaching Institution, Charité Universitätsmedizin, Unter den Linden 21, 10117, Berlin, Germany

    Franz X. Kleber

  2. Charité Universitätsmedizin, Berlin, Germany

    Antonia Schulz & Telse Hauschild

  3. Medical Scientific Affairs, B. Braun Vascular Systems, Berlin, Germany

    Matthias Waliszewski

  4. Ernst von Bergmann Klinikum, Potsdam, Germany

    Telse Hauschild

  5. Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany

    Michael Böhm, Bodo Cremers, Bruno Scheller & Yvonne P. Clever

  6. Deutsche Klinik für Diagnostik, Wiesbaden, Germany

    Ulrich Dietz

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  1. Franz X. Kleber
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Correspondence to Bruno Scheller.

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Kleber, F.X., Schulz, A., Waliszewski, M. et al. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol 104, 217–225 (2015). https://doi.org/10.1007/s00392-014-0775-2

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  • DOI: https://doi.org/10.1007/s00392-014-0775-2

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