Author + information
- Received November 10, 2014
- Revision received December 22, 2014
- Accepted January 15, 2015
- Published online June 1, 2015.
- Sebastian Kufner, MD∗∗ (, )
- Salvatore Cassese, MD∗,
- Marco Valeskini, Cand Med∗,
- Franz-Josef Neumann, MD†,
- Stefanie Schulz-Schüpke, MD∗,‡,
- Petra Hoppmann, MD§,
- Massimiliano Fusaro, MD∗,
- Heribert Schunkert, MD∗,‡,
- Karl-Ludwig Laugwitz, MD‡,§,
- Adnan Kastrati, MD∗,‡,
- Robert A. Byrne, MB, BCh, PhD∗,
- ISAR-DESIRE 3 Investigators
- ∗Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany
- †Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Freiburg-Bad Krozingen, Germany
- ‡DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
- §I. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
- ↵∗Reprint requests and correspondence:
Dr. Sebastian Kufner, Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität “München”, Lazarettstrasse 36, 80636 Munich, Germany.
Objectives This study sought to investigate the long-term comparative efficacy and safety of paclitaxel-eluting balloon (PEB), paclitaxel-eluting stent (PES), or balloon angioplasty (BA) for the treatment of drug-eluting stent restenosis.
Background The optimal treatment of drug-eluting stent restenosis remains unknown. Although PEB has shown encouraging results, the long-term clinical efficacy and safety of PEB remains poorly defined.
Methods A total of 402 patients with clinically significant restenosis in limus-eluting stents were randomly assigned to receive PEB (n = 137), PES (n = 131), or BA (n = 134). For this analysis, PEB versus PES and PEB versus BA were compared. The primary efficacy and safety endpoints were target lesion revascularization and the composite of death or myocardial infarction.
Results At a median follow-up of 3 years, the risk of target lesion revascularization was comparable with PEB versus PES (hazard ratio [HR]: 1.46, 95% confidence interval [CI]: 0.91 to 2.33; p = 0.11) and lower with PEB versus BA (HR: 0.51, 95% CI: 0.34 to 0.74; p < 0.001). The risk of death/myocardial infarction tended to be lower with PEB versus PES (HR: 0.55, 95% CI: 0.28 to 1.07; p = 0.08), due to a lower risk of death (HR: 0.38, 95% CI: 0.17 to 0.87; p = 0.02). The risk of death/myocardial infarction was similar with PEB versus BA (HR: 0.96, 95% CI: 0.46 to 2.0; p = 0.91).
Conclusions At 3 years, the use of PEB as compared with PES to treat patients with limus-eluting stent restenosis has similar efficacy and safety. PEB remains superior to BA. The sustained efficacy without trade-off in safety supports the role of PEB as treatment option for patients with drug-eluting stent restenosis. (Intracoronary Stenting and Angiographic Results: Drug Eluting Stent In-Stent Restenosis: 3 Treatment Approaches [ISAR-DESIRE 3]; NCT00987324)
Dr. Kastrati has been issued or has applied for patents related to stent technology. Dr. Byrne has received lecture fees from B. Braun Melsungen and Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Kufner and Cassese contributed equally to this work.
- Received November 10, 2014.
- Revision received December 22, 2014.
- Accepted January 15, 2015.
- American College of Cardiology Foundation