| 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. | |
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MedLine Citation:
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PMID: 23206837 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: Deutsches Herzzentrum. |
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Authors:
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Robert A Byrne; Franz-Josef Neumann; Julinda Mehilli; Susanne Pinieck; Britta Wolff; Klaus Tiroch; Stefanie Schulz; Massimiliano Fusaro; Ilka Ott; Tareq Ibrahim; Jörg Hausleiter; Christian Valina; Jürgen Pache; Karl-Ludwig Laugwitz; Steffen Massberg; Adnan Kastrati; |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2012-12-01 |
Journal Detail:
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Title: Lancet Volume: 381 ISSN: 1474-547X ISO Abbreviation: Lancet Publication Date: 2013 Feb |
Date Detail:
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Created Date: 2013-02-12 Completed Date: 2013-03-05 Revised Date: 2013-04-19 |
Medline Journal Info:
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Nlm Unique ID: 2985213R Medline TA: Lancet Country: England |
Other Details:
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Languages: eng Pagination: 461-7 Citation Subset: AIM; IM |
Copyright Information:
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Copyright © 2013 Elsevier Ltd. All rights reserved. |
Affiliation:
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Deutsches Herzzentrum, Technische Universität, Munich, Germany. byrne@dhm.mhn.de |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00987324 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Angioplasty, Balloon, Coronary / methods*, mortality Coronary Angiography / methods Coronary Restenosis / mortality, radiography, therapy* Drug-Eluting Stents* Female Follow-Up Studies Germany Humans Male Middle Aged Paclitaxel / therapeutic use* Prospective Studies Risk Assessment Severity of Illness Index Sirolimus / therapeutic use Survival Analysis Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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33069-62-4/Paclitaxel; 53123-88-9/Sirolimus |
| Investigator | |
Investigator/Affiliation:
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A Kastrati / ; J Mehilli / ; K Tiroch / ; C Schmitt / ; D Poci / ; P Barthel / ; J Mehilli / ; R A Byrne / ; S Schulz / ; K A Fiedler / ; H Holle / ; K Hösl / ; S Kufner / ; F Maimer-Rodrigues / ; H Paul / ; N Rifatov / ; G Schömig / ; B Wolff / ; B von Merzljak / ; I Zenullahi / ; R A Byrne / ; S Pinieck / ; D Blersch / ; S Cassese / ; S Hurt / ; L King / ; T Tada / |
| Comments/Corrections | |
Comment In:
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Dtsch Med Wochenschr. 2013 Mar;138(12):561 Lancet. 2013 Feb 9;381(9865):431-3 [PMID: 23206833 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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