title: Randomized comparison between 3-month Cre8 DES vs. 1-month Vision/Multilink8 BMS neointimal coverage assessed by OCT evaluation: the DEMONSTRATE study.
abstract: BACKGROUND
  It has been hypothesized that incomplete endothelialization and delayed vascular healing may trigger stent thrombosis events after drug-eluting stent (DES) implantation. We aimed to demonstrate non-inferiority in terms of neointimal coverage of novel Cre8 DES at 3 months, compared to Vision/Multilink8 Bare Metal Stent (BMS) at 1month.
  
  
  METHODS
  The ranDomizEd coMparisOn betweeN novel Cre8 DES and BMS to assess neoinTimal coveRAge by OCT Evaluation (DEMONSTRATE) was a multicenter, randomized, parallel group study. Thirty-eight patients undergoing angioplasty of de-novo coronary lesion were randomized to Cre8 (19) or Vision/Multilink8 (19) stent placement at 6 OCT-experienced centers. Primary end-point was the Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of <30%, determined by OCT at 3 and 1 months for Cre8 and Vision/Multilink8, respectively. Percentage of uncovered/malapposed stent struts, neointimal growth and thickness were the main secondary end-points.
  
  
  RESULTS
  The primary end-point of RUTTS score<30% occurred in 99.8% (899/901) of Cre8 struts and in 99.6% (1116/1121) of Vision/Multilink8 struts (difference 0.2, CI 95% -0.2 to 0.6, p for noninferiority<0.001). The percentage of uncovered/malapposed struts was comparable (0.36±0.64 vs. 0.12±0.24, p=0.145) in the two study groups, while both neointimal percentage area (8.46±5.29 vs. 19.84±15.93, p<0.001) and thickness (0.07±0.04 vs. 0.16±0.12, p<0.001) were significantly reduced by Cre8 stent.
  
  
  CONCLUSIONS
  The Cre8 DES at 3 months has comparable strut coverage to Vision/Multilink8 BMS at 1 month while preserving a greater efficacy in neo-intima formation reduction. Further studies to assess clinical implication of these Cre8 characteristics are warranted.
authors.affiliation: Centro per la Lotta contro l'Infarto - Fondazione Onlus, Rome, Italy; San Giovanni-Addolorata Hospital, Rome, Italy. Electronic address: fprati@hsangiovanni.roma.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Prati
authors.affiliation: Centro per la Lotta contro l'Infarto - Fondazione Onlus, Rome, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Romagnoli
authors.affiliation: Azienda Ospedaliera - Universitaria S. Anna, Ferrara, Italy; Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.affiliation: Università Cattolica Del Sacro Cuore, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Burzotta
authors.affiliation: Azienda Ospedaliera Ordine Mauriziano di Torino, Turin, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: De Benedictis
authors.affiliation: Ospedale Civile, Bassano Del Grappa, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Ramondo
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, NY, USA.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Pieter R
authors.initials: PR
authors.lastname: Stella
mesh_terms: D000368:Aged; D054855:Drug-Eluting Stents / Q000592:standards*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima / Q000175:diagnosis* / Q000628:therapy*; D015607:Stents / Q000592:standards; D013997:Time Factors; D041623:Tomography, Optical Coherence / Q000379:methods* / Q000592:standards*; D016896:Treatment Outcome
keywords: Drug-eluting stent; Optical coherence tomography; Randomized controlled trial