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: 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Deutsches Herzzentrum.
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany. byrne@dhm.mhn.de
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Susanne
authors.initials: S
authors.lastname: Pinieck
authors.forename: Britta
authors.initials: B
authors.lastname: Wolff
authors.forename: Klaus
authors.initials: K
authors.lastname: Tiroch
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schulz
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Fusaro
authors.forename: Ilka
authors.initials: I
authors.lastname: Ott
authors.forename: Tareq
authors.initials: T
authors.lastname: Ibrahim
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.forename: Christian
authors.initials: C
authors.lastname: Valina
authors.forename: Jürgen
authors.initials: J
authors.lastname: Pache
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Laugwitz
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods* / Q000401:mortality; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D020123:Sirolimus / Q000627:therapeutic use; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D020123:Sirolimus