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Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter

Clinical Research in Cardiology volume 97, pages 773–781 (2008)Cite this article

Abstract

Background

We are presenting an extension of a previously published trial on the efficacy and safety of a paclitaxel-coated balloon in coronary ISR in a larger patient population and after a complete follow-up of 2 years.

Methods

Hundred eight patients were enrolled in two separately randomized, double-blind multicenter trials on efficacy and safety using an identical protocol. Patients were treated by the paclitaxel-coated (3 µg/mm2 balloon surface; Paccocath) or an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥70% and <30 mm length with a vessel diameter of 2.5–3.5 mm. The primary endpoint was angiographic late lumen loss in-segment. Secondary endpoints included binary restenosis rate and major adverse cardiovascular events (MACE).

Results

Quantitative coronary angiography revealed no differences in baseline parameters. After six months in-segment late lumen loss was 0.81 ± 0.79 mm in the uncoated balloon group vs. 0.11 ± 0.45 mm (P < 0.001) in the drug-coated balloon group resulting in a binary restenosis rate of 25/49 vs. 3/47 (P < 0.001). Until 12 months post procedure 20 patients in the uncoated balloon group compared to two patients in the coated balloon group required target lesion revascularization (P = 0.001). Between 12 and 24 only two MACE were recorded, a stroke in the uncoated and a target lesion revascularization in the coated balloon group.

Conclusion

Treatment of coronary ISR with paclitaxel-coated balloon catheters persistently reduces repeat restenosis up to 2 years. (ClinicalTrials.gov Identifier: NCT00106587, NCT00409981).

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Acknowledgments

The authors thank Matthias Braeutigam, MD, Schering AG Berlin, for supporting basic experiments leading to the clinical studies. The authors further thank Wolfgang Gimbel, MD for clinical monitoring, Bettina Kelsch for critical data review and report writing, Bianca Werner and Nicole Hollinger for handling the database, and Kevin Wilhelmi for assistance in quantitative analysis of coronary angiographies. Statistical analysis was supported by BIAS GmbH, Berlin, Germany.

Disclosures: The study was supported by Bavaria Medizintechnik GmbH, Oberpfaffenhoven and Bayer-Schering Pharma AG, Berlin, both Germany. Dr. Scheller and Dr. Speck report being co-inventors of a patent application for various methods of restenosis inhibition, including the technique employed in this trial, by Charité University Hospital, Berlin. Dr. Speck reports serving as a consultant to Bayer-Schering AG, Berlin.

Author information

Affiliations

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

    Bruno Scheller & Michael Böhm

  2. Klinik für Innere Medizin III, Universitätsklinikum, Freiburg, Germany

    Christoph Hehrlein

  3. Medizinische Klinik mit Schwerpunkt Kardiologie, Universitätsklinikum Charité, Campus Virchow-Klinikum, Berlin, Germany

    Wolfgang Bocksch

  4. Medizinische Klinik und Poliklinik mit Schwerpunkt Kardiologie, Angiologie, Pulmonologie, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, Germany

    Wolfgang Rutsch

  5. I. Medizinische Klinik, Universitätsklinikum Mannheim, Ruprecht-Karls-Universität Heidelberg, Mannheim, Germany

    Dariush Haghi

  6. Kardiologie, Deutsche Klinik für Diagnostik, Wiesbaden, Germany

    Ulrich Dietz

  7. Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, Germany

    Ulrich Speck

Authors
  1. Bruno Scheller
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  2. Christoph Hehrlein
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  3. Wolfgang Bocksch
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  4. Wolfgang Rutsch
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  5. Dariush Haghi
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  6. Ulrich Dietz
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  7. Michael Böhm
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  8. Ulrich Speck
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Correspondence to Bruno Scheller.

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Scheller, B., Hehrlein, C., Bocksch, W. et al. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol 97, 773–781 (2008). https://doi.org/10.1007/s00392-008-0682-5

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  • DOI: https://doi.org/10.1007/s00392-008-0682-5

Keywords

  • paccocath
  • drug-coated balloon
  • in-stent restenosis