Document Detail


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.
MedLine Citation:
PMID:  23206837     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-12-01
Journal Detail:
Title:  Lancet     Volume:  381     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-02-12     Completed Date:  2013-03-05     Revised Date:  2013-06-04    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  461-7     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2013 Elsevier Ltd. All rights reserved.
Affiliation:
Deutsches Herzzentrum, Technische Universität, Munich, Germany. byrne@dhm.mhn.de
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00987324
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MeSH Terms
Descriptor/Qualifier:
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:
33069-62-4/Paclitaxel; 53123-88-9/Sirolimus
Investigator
Investigator/Affiliation:
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:
Nat Rev Cardiol. 2013 Feb;10(2):62   [PMID:  23247311 ]
Lancet. 2013 Feb 9;381(9865):431-3   [PMID:  23206833 ]
Dtsch Med Wochenschr. 2013 Mar;138(12):561   [PMID:  23607116 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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