title: A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study.
abstract: OBJECTIVE
  This study sought to define the impact of paclitaxel-coated balloon angioplasty for treatment of drug-eluting stent restenosis compared with uncoated balloon angioplasty alone.
  
  
  BACKGROUND
  Drug-coated balloon angioplasty is associated with favorable results for treatment of bare-metal stent restenosis.
  
  
  METHODS
  In this prospective, single-blind, multicenter, randomized trial, the authors randomly assigned 110 patients with drug-eluting stent restenoses located in a native coronary artery to paclitaxel-coated balloon angioplasty or uncoated balloon angioplasty. Dual antiplatelet therapy was prescribed for 6 months. Angiographic follow-up was scheduled at 6 months. The primary endpoint was late lumen loss. The secondary clinical endpoint was a composite of cardiac death, myocardial infarction attributed to the target vessel, or target lesion revascularization.
  
  
  RESULTS
  There was no difference in patient baseline characteristics or procedural results. Angiographic follow-up rate was 91%. Treatment with paclitaxel-coated balloon was superior to balloon angioplasty alone with a late loss of 0.43 ± 0.61 mm versus 1.03 ± 0.77 mm (p < 0.001), respectively. Restenosis rate was significantly reduced from 58.1% to 17.2% (p < 0.001), and the composite clinical endpoint was significantly reduced from 50.0% to 16.7% (p < 0.001), respectively.
  
  
  CONCLUSIONS
  Paclitaxel-coated balloon angioplasty is superior to balloon angioplasty alone for treatment of drug-eluting stent restenosis. (PEPCAD DES-Treatment of DES-In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting PTCA Catheter [PEPCAD-DES]; NCT00998439).
authors.affiliation: Medizinische Klinik 2, Universitätsklinikum Erlangen, Erlangen, Germany. rittger@arcor.de
authors.forename: Harald
authors.initials: H
authors.lastname: Rittger
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachmann
authors.forename: Anil-M
authors.initials: AM
authors.lastname: Sinha
authors.forename: Matthias
authors.initials: M
authors.lastname: Waliszewski
authors.forename: Marc
authors.initials: M
authors.lastname: Ohlow
authors.forename: Andreas
authors.initials: A
authors.lastname: Brugger
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
authors.forename: Ralf
authors.initials: R
authors.lastname: Birkemeyer
authors.forename: Volkhard
authors.initials: V
authors.lastname: Kurowski
authors.forename: Ole-A
authors.initials: OA
authors.lastname: Breithardt
authors.forename: Martin
authors.initials: M
authors.lastname: Schmidt
authors.forename: Stefan
authors.initials: S
authors.lastname: Zimmermann
authors.forename: Sandra
authors.initials: S
authors.lastname: Lonke
authors.forename: Moritz
authors.initials: M
authors.lastname: von Cranach
authors.forename: The-Vinh
authors.initials: TV
authors.lastname: Nguyen
authors.forename: Werner G
authors.initials: WG
authors.lastname: Daniel
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000972:Antineoplastic Agents, Phytogenic / Q000494:pharmacology; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000494:pharmacology*; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel