title: Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial.
abstract: OBJECTIVE
  Little is known about the respective healing responses and clinical efficacy and safety of drug-eluting balloons (DEB) and the second generation of drug-eluting stents (DES) when used to treat in-stent restenosis (ISR). In this study, we set out to compare prospectively the healing characteristics, as assessed by optical coherence tomography (OCT), of DEB versus DES after treatment of ISR in bare metal stents (BMS).
  
  
  RESULTS
  Fifty patients with BMS ISR were randomised to treatment with a paclitaxel-eluting balloon vs. an everolimus-eluting stent (EES). The primary endpoint was the percentage of uncovered struts, assessed with OCT at nine months, as a marker of vessel wall healing. A mean of 366±135 and 636±184 struts were analysed per patient in the DEB and EES groups, respectively. The percentage of uncovered struts per patient was significantly lower with DEB vs. EES (1.4% vs. 3.1%, p=0.025). Mean neointimal hyperplasia area was 2.4±1.08 mm in DEB vs. 1.92±0.67 mm in EES (p=0.1806), while the percentage of malapposed struts per patient was very low in both groups (0.2% vs. 0.3%, p=0.699). At nine months, angiographic in-stent MLD (minimum lumen diameter) was lower (2.13 vs. 2.54 mm, p=0.006), while diameter stenosis (26.4 vs. 11.4%, p=0.002), and LLL (0.28 vs. 0.07 mm, p=0.1) were higher after DEB compared to EES. During one-year follow-up, we did not observe differences in the rates of death, TLR (target lesion revascularisation) or stent thrombosis.
  
  
  CONCLUSIONS
  DEB appears to be associated with better healing characteristics, as assessed by stent strut coverage with OCT, but tended to be slightly less effective compared to EES. These findings give support to the use of either DEB or EES as valuable treatment options for ISR.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT 01065532.
authors.affiliation: Department of Cardiovascular Medicine, University Hospitals Leuven & Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.
authors.forename: Tom
authors.initials: T
authors.lastname: Adriaenssens
authors.forename: Jo
authors.initials: J
authors.lastname: Dens
authors.forename: Giovanni
authors.initials: G
authors.lastname: Ughi
authors.forename: Johan
authors.initials: J
authors.lastname: Bennett
authors.forename: Christophe
authors.initials: C
authors.lastname: Dubois
authors.forename: Peter
authors.initials: P
authors.lastname: Sinnaeve
authors.forename: Stefanus
authors.initials: S
authors.lastname: Wiyono
authors.forename: Mark
authors.initials: M
authors.lastname: Coosemans
authors.forename: Ann
authors.initials: A
authors.lastname: Belmans
authors.forename: Jan
authors.initials: J
authors.lastname: D'hooge
authors.forename: Mathias
authors.initials: M
authors.lastname: Vrolix
authors.forename: Walter
authors.initials: W
authors.lastname: Desmet
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000473:pathology*; D003331:Coronary Vessels / Q000601:surgery; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D041623:Tomography, Optical Coherence / Q000379:methods; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus