Long-Term Efficacy and Safety of Paclitaxel-Eluting Balloon for the Treatment of Drug-Eluting Stent Restenosis: 3-Year Results of a Randomized Controlled Trial.

Kufner, Sebastian; Cassese, Salvatore; Valeskini, Marco; Neumann, Franz-Josef; Schulz-Schüpke, Stefanie; Hoppmann, Petra; Fusaro, Massimiliano; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan; Byrne, Robert A

doi:10.1016/j.jcin.2015.01.031

journal article

Title:: Long-Term Efficacy and Safety of Paclitaxel-Eluting Balloon for the Treatment of Drug-Eluting Stent Restenosis: 3-Year Results of a Randomized Controlled Trial.
Document type:: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Article
Author(s):: Kufner, Sebastian; Cassese, Salvatore; Valeskini, Marco; Neumann, Franz-Josef; Schulz-Schüpke, Stefanie; Hoppmann, Petra; Fusaro, Massimiliano; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan; Byrne, Robert A
Abstract:: 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.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.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.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).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).
Journal title abbreviation:: JACC Cardiovasc Interv
Year:: 2015
Journal volume:: 8
Journal issue:: 7
Pages contribution:: 877-84
Language:: eng
Fulltext / DOI:: doi:10.1016/j.jcin.2015.01.031
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/26003022
Print-ISSN:: 1936-8798
TUM Institution:: I. Medizinische Klinik und Poliklinik (Kardiologie); Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (Prof. Schunkert)
BibTeX

Occurrences:

mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Lehr- und Forschungskooperationen mit den Kliniken und Instituten am Deutschen Herzzentrum Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (DHM) (Prof. Schunkert)2015

mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Innere Medizin I, Kardiologie (Prof. Laugwitz)2015