title: Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes.
abstract: OBJECTIVE
  The aim of this study was to demonstrate that the prevention of early scaffold area shrinkage of the ABSORB BVS (Rev.1.1, Abbott Vascular, Santa Clara, California) was sustained and not simply delayed by a few months.
  
  
  BACKGROUND
  With improved scaffold design and modified manufacturing process of its polymer, the second iteration of ABSORB (BVS 1.1) has improved performance to prevent a scaffold area reduction at 6 months.
  
  
  METHODS
  Fifty-six patients were enrolled and received 57 ABSORB scaffolds. Quantitative coronary angiography, intravascular ultrasound (IVUS), analysis of radiofrequency backscattering, echogenicity and optical coherence tomography (OCT) were performed at baseline and at 12-month follow-up.
  
  
  RESULTS
  Overall the scaffold area remained unchanged with IVUS as well as with OCT, whereas the radiofrequency backscattering and the echogenicity of the struts decreased by 16.8% (p < 0.001) and 20% (p < 0.001), respectively; more specifically, the strut core area on OCT decreased by 11.4% (p = 0.003). Despite the absence of scaffold area loss, pharmacological vasomotion was restored. On an intention-to-treat basis, the angiographic late lumen loss amounted to 0.27 ± 0.32 mm with an IVUS relative decrease in minimal lumen area of 1.94% (p = 0.12), without significant changes in mean lumen area. The OCT at follow-up showed that 96.69% of the struts were covered and that malapposition, initially observed in 18 scaffolds was only detected at follow-up in 4 scaffolds. Two patients experienced peri-procedural and iatrogenic myocardial infarction, respectively, whereas 2 underwent repeat intervention, resulting in the major adverse cardiac event rate of 7.1% (4 of 56).
  
  
  CONCLUSIONS
  The 12-month performance of the second-generation ABSORB bioresorbable everolimus-eluting scaffold justifies the conduct of a randomized trial against current best standards. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00856856).
authors.affiliation: Thorax Center, Erasmus Medical Center, Gravendijkwal 230, Rotterdam, the Netherlands. p.w.j.c.serruys@erasmusmc.nl
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Pieter C
authors.initials: PC
authors.lastname: Smits
authors.forename: Jacques
authors.initials: J
authors.lastname: Koolen
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Bernard
authors.initials: B
authors.lastname: de Bruyne
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Dougal
authors.initials: D
authors.lastname: McClean
authors.forename: Robert-Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.forename: Ian
authors.initials: I
authors.lastname: Meredith
authors.forename: Cecile
authors.initials: C
authors.lastname: Dorange
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.forename: Karine Miquel
authors.initials: KM
authors.lastname: Hebert
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D023921:Coronary Stenosis / Q000175:diagnosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus