title: Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial.
abstract: OBJECTIVE
  To compare the tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent (ZES) vs. a fluoropolymer-coated everolimus-eluting stent (EES) at 13 months, using optical coherence tomography (OCT) in an 'all-comers' population of patients, in order to clarify the mechanism of eventual differences in the biocompatibility and thrombogenicity of the devices.
  
  
  RESULTS
  Patients randomized to angiographic follow-up in the RESOLUTE All Comers trial (NCT00617084) at pre-specified OCT sites underwent OCT follow-up at 13 months. Tissue coverage and apposition were assessed strut by strut, and the results in both treatment groups were compared using multilevel logistic or linear regression, as appropriate, with clustering at three different levels: patient, lesion, and stent. Fifty-eight patients (30 ZES and 28 EES), 72 lesions, 107 stents, and 23 197 struts were analysed. Eight hundred and eighty-seven and 654 uncovered struts (7.4 and 5.8%, P= 0.378), and 216 and 161 malapposed struts (1.8 and 1.4%, P= 0.569) were found in the ZES and EES groups, respectively. The mean thickness of coverage was 116 ± 99 µm in ZES and 142 ± 113 µm in EES (P= 0.466). No differences in per cent neointimal volume obstruction (12.5 ± 7.9 vs. 15.0 ± 10.7%) or other areas-volumetric parameters were found between ZES and EES, respectively.
  
  
  CONCLUSIONS
  No significant differences in tissue coverage, malapposition, or lumen/stent areas and volumes were detected by OCT between the hydrophilic polymer-coated ZES and the fluoropolymer-coated EES at 13-month follow-up.
authors.affiliation: Erasmus Medical Centre, Thoraxcenter, Ba583a, 's-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands. jlgutierrez@medynet.com
authors.forename: Juan Luis
authors.initials: JL
authors.lastname: Gutiérrez-Chico
authors.forename: Robert Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Evelyn
authors.initials: E
authors.lastname: Regar
authors.forename: Willem J
authors.initials: WJ
authors.lastname: van der Giessen
authors.forename: Henning
authors.initials: H
authors.lastname: Kelbæk
authors.forename: Kari
authors.initials: K
authors.lastname: Saunamäki
authors.forename: Javier
authors.initials: J
authors.lastname: Escaned
authors.forename: Nieves
authors.initials: N
authors.lastname: Gonzalo
authors.forename: Carlo
authors.initials: C
authors.lastname: di Mario
authors.forename: Francesco
authors.initials: F
authors.lastname: Borgia
authors.forename: Eveline
authors.initials: E
authors.lastname: Nüesch
authors.forename: Héctor M
authors.initials: HM
authors.lastname: García-García
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D023921:Coronary Stenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011108:Polymers; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000008:administration & dosage*
chemical_list: D011108:Polymers; D050257:Tubulin Modulators; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus