Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial.

Byrne, Robert A; Neumann, Franz-Josef; Mehilli, Julinda; Pinieck, Susanne; Wolff, Britta; Tiroch, Klaus; Schulz, Stefanie; Fusaro, Massimiliano; Ott, Ilka; Ibrahim, Tareq; Hausleiter, Jörg; Valina, Christian; Pache, Jürgen; Laugwitz, Karl-Ludwig; Massberg, Steffen; Kastrati, Adnan

doi:10.1016/S0140-6736(12)61964-3

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Document type:: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Article
Author(s):: Byrne, Robert A; Neumann, Franz-Josef; Mehilli, Julinda; Pinieck, Susanne; Wolff, Britta; Tiroch, Klaus; Schulz, Stefanie; Fusaro, Massimiliano; Ott, Ilka; Ibrahim, Tareq; Hausleiter, Jörg; Valina, Christian; Pache, Jürgen; Laugwitz, Karl-Ludwig; Massberg, Steffen; Kastrati, Adnan
Title:: Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial.
Abstract:: The best way to manage restenosis in patients who have previously received a drug-eluting stent is unknown. We investigated the efficacy of paclitaxel-eluting balloons (PEB), paclitaxel-eluting stents (PES), and balloon angioplasty in these patients.In this randomised, open-label trial, we enrolled patients older than 18 years with restenosis of at least 50% after implantation of any limus-eluting stent at three centres in Germany between Aug 3, 2009, and Oct 27, 2011. Patients were randomly assigned (1:1:1; stratified according to centre) to receive PEB, PES, or balloon angioplasty alone by means of sealed, opaque envelopes containing a computer-generated sequence. Patients and investigators were not masked to treatment allocation, but events and angiograms were assessed by individuals who were masked. The primary endpoint was diameter stenosis at follow-up angiography at 6-8 months. Primary analysis was done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00987324.We enrolled 402 patients, of whom 137 (34%) were assigned to PEB, 131 (33%) to PES, and 134 (33%) to balloon angioplasty. Follow-up angiography at 6-8 months was available for 338 (84%) patients. PEB was non-inferior to PES in terms of diameter stenosis (38·0% [SD 21·5] vs 37·4% [21·8]; difference 0·6%, one-sided 95% CI 4·9%; p(non-inferiority)=0·007; non-inferiority margin of 7%). Findings were consistent in per-protocol analysis (p(non-inferiority)=0·011). PEB and PES were superior to balloon angioplasty alone (54·1% [25·0]; p(superiority)<0·0001 for both comparisons). Frequency of death, myocardial infarction, or target lesion thrombosis did not differ between groups.By obviating the need for additional stent implantation, PEB could be a useful treatment for patients with restenosis after implantation of a drug-eluting stent.Deutsches Herzzentrum.
Journal title abbreviation:: Lancet
Year:: 2013
Journal volume:: 381
Journal issue:: 9865
Pages contribution:: 461-7
Language:: eng
Fulltext / DOI:: doi:10.1016/S0140-6736(12)61964-3
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/23206837
Print-ISSN:: 0140-6736
TUM Institution:: I. Medizinische Klinik und Poliklinik (Kardiologie)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Innere Medizin I, Kardiologie (Prof. Laugwitz)2013