title: Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: comparative sequential assessment with optical coherence tomography until complete resorption of the polymer.
abstract: BACKGROUND
  Biolimus-eluting stents (BESs) with a biodegradable polymer in abluminal coating achieve more complete coverage at 9 months compared with sirolimus-eluting stents (SESs) with a durable polymer, as assessed by optical coherence tomography (OCT). Whether this advantage persists or augments after complete resorption of the polymer (>12 months) is unknown.
  
  
  METHODS
  The LEADERS trial compared the performance of BES with that of SES. Patients were randomly allocated to a sequential angiographic follow-up, including OCT in selected sites, at 9 and 24 months. Struts coverage was compared using Bayesian hierarchical models as the primary outcome for the OCT substudy.
  
  
  RESULTS
  Fifty-six patients (26 BES, 30 SES) were enrolled in the OCT substudy. Twenty-one patients (10 BES, 11 SES) agreed to perform a second OCT follow-up at 24 months. Eleven lesions and 12 stents were analyzed sequentially in the BES group (2,455 struts at 9 months, 2,131 struts at 24 months) and 11 lesions and 18 stents in the SES group (3,421 struts at 9 months, 4,170 struts at 24 months). The previously reported advantage of BES over SES in terms of better strut coverage at 9 months was followed by improvement in coverage of the SES, resulting in identical coverage in both BES and SES at 24 months: 1.5% versus 1.8% uncovered struts, difference -0.2%, 95% credibility interval, -3.2% to 2.6%, P = .84.
  
  
  CONCLUSIONS
  More complete strut coverage of BES as compared with SES at 9 months was followed by improvement of coverage in SES between 9 and 24 months and a similar long-term coverage in both stent types at 24 months.
authors.affiliation: Erasmus Medical Centre, Thoraxcentre, Rotterdam, The Netherlands. jlgutierrez@medynet.com
authors.forename: Juan Luis
authors.initials: JL
authors.lastname: Gutiérrez-Chico
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: Héctor M
authors.initials: HM
authors.lastname: García-García
authors.forename: Evelyn
authors.initials: E
authors.lastname: Regar
authors.forename: Eveline
authors.initials: E
authors.lastname: Nüesch
authors.forename: Francesco
authors.initials: F
authors.lastname: Borgia
authors.forename: Willem J
authors.initials: WJ
authors.lastname: van der Giessen
authors.forename: Simon
authors.initials: S
authors.lastname: Davies
authors.forename: Robert Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Gioel Gabrio
authors.initials: GG
authors.lastname: Secco
authors.forename: Susanne
authors.initials: S
authors.lastname: Meis
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Carlo
authors.initials: C
authors.lastname: di Mario
mesh_terms: D000328:Adult; D015906:Angioplasty, Balloon, Coronary; D016022:Case-Control Studies; D023921:Coronary Stenosis / Q000473:pathology / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D011108:Polymers / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D012709:Serum Albumin / Q000008:administration & dosage; D000075462:Serum Albumin, Human; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: C422455:ALB protein, human; D007166:Immunosuppressive Agents; D011108:Polymers; D012709:Serum Albumin; C518022:umirolimus; D020123:Sirolimus; D000075462:Serum Albumin, Human