Author + information
- Received January 2, 2012
- Accepted January 18, 2012
- Published online March 1, 2012.
- Bruno Scheller, MD⁎,⁎ (, )
- Yvonne P. Clever, MD⁎,
- Bettina Kelsch, M.Chem†,
- Christoph Hehrlein, MD‡,
- Wolfgang Bocksch, MD§,
- Wolfgang Rutsch, MD∥,
- Dariush Haghi, MD¶,
- Ulrich Dietz, MD#,
- Ulrich Speck, PhD†,
- Michael Böhm, MD⁎ and
- Bodo Cremers, MD⁎
- ↵⁎Reprint requests and correspondence:
Prof. Dr. Bruno Scheller, Klinik für Innere Medizin, III, Universitätsklinikum des Saarlandes, Kirrberger Strasse, 66421 Homburg, Saar, Germany
Objectives This study presents long-term clinical follow-up, including binary restenosis rate and major adverse cardiovascular events, of the PACCOCATH-ISR (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons) I and II trial.
Background The PACCOCATH-ISR trial was a first-in-human study with a drug-coated balloon catheter and the first study for the treatment of coronary ISR with a drug-coated balloon. So, far no long-term follow-up data have been presented.
Methods This study enrolled 108 patients in a randomized, double-blinded multicenter trial on the efficacy and safety of a paclitaxel-coated balloon (3 μg/mm2 balloon surface; PACCOCATH [Bayer AG, Germany]) compared with an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥70% and <30-mm length with a vessel diameter of 2.5 to 3.5 mm. The primary endpoint was angiographic late lumen loss in-segment after 6 months. Combined antiplatelet therapy was continued only for 1 month followed by treatment with aspirin alone.
Results During a follow-up of 5.4 ± 1.2 years, the clinical event rate was significantly reduced in patients treated with the drug-coated balloon (major adverse cardiovascular events: 59.3% vs. 27.8%, p = 0.009), which was mainly driven by the reduction of target lesion revascularization from 38.9% to 9.3% (p = 0.004).
Conclusions Treatment of coronary ISR with paclitaxel-coated balloon catheters is safe and persistently reduces repeat revascularization during long-term follow-up. The initial results were sustained over the 5-year period. (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR I]; NCT00106587. Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR II]; NCT00409981)
The study was supported by Bavaria Medizintechnik GmbH, Oberpfaffenhoven and Bayer-Schering Pharma AG, Berlin. Drs. Scheller and Speck have been named as coinventors of a patent application for various methods of restenosis inhibition, including the technique employed in this trial, by Charité University Hospital, Berlin. Drs. Scheller and Cremers receive lecture fees from B. Braun. Dr. Speck has served as a consultant to Bayer-Schering AG, Berlin. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 2, 2012.
- Accepted January 18, 2012.
- American College of Cardiology Foundation