Clinical Research in Cardiology

, Volume 97, Issue 10, pp 773–781

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

Authors

    • Klinik für Innere Medizin IIIUniversitätsklinikum des Saarlandes
  • Christoph Hehrlein
    • Klinik für Innere Medizin IIIUniversitätsklinikum
  • Wolfgang Bocksch
    • Medizinische Klinik mit Schwerpunkt KardiologieUniversitätsklinikum Charité
  • Wolfgang Rutsch
    • Medizinische Klinik und Poliklinik mit Schwerpunkt Kardiologie, Angiologie, PulmonologieCharité-Universitätsmedizin Berlin
  • Dariush Haghi
    • I. Medizinische KlinikUniversitätsklinikum Mannheim, Ruprecht-Karls-Universität Heidelberg
  • Ulrich Dietz
    • KardiologieDeutsche Klinik für Diagnostik
  • Michael Böhm
    • Klinik für Innere Medizin IIIUniversitätsklinikum des Saarlandes
  • Ulrich Speck
    • Institut für RadiologieCharité-Universitätsmedizin Berlin
ORIGINAL PAPER

DOI: 10.1007/s00392-008-0682-5

Cite this article as:
Scheller, B., Hehrlein, C., Bocksch, W. et al. Clin Res Cardiol (2008) 97: 773. doi:10.1007/s00392-008-0682-5

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).

Keywords

paccocathdrug-coated balloonin-stent restenosis

Copyright information

© Springer-Verlag 2008