title: Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes.
abstract: BACKGROUND
  The first generation of the bioresorbable everolimus drug-eluting vascular scaffold showed signs of shrinkage at 6 months, which largely contributed to late luminal loss. Nevertheless, late luminal loss was less than that observed with bare metal stents. To maintain the mechanical integrity of the device up to 6 months, the scaffold design and manufacturing process of its polymer were modified.
  
  
  RESULTS
  Quantitative coronary angiography, intravascular ultrasound with analysis of radiofrequency backscattering, and as an optional assessment, optical coherence tomography (OCT) were performed at baseline and at a 6-month follow-up. Forty-five patients successfully received a single bioresorbable everolimus drug-eluting vascular scaffold. One patient had postprocedural release of myocardial enzyme without Q-wave occurrence; 1 patient with OCT-diagnosed disruption of the scaffold caused by excessive postdilatation was treated 1 month later with a metallic drug-eluting stent. At follow-up, 3 patients declined recatheterization, 42 patients had quantitative coronary angiography, 37 had quantitative intravascular ultrasound, and 25 had OCT. Quantitative coronary angiography disclosed 1 edge restenosis (1 of 42; in-segment binary restenosis, 2.4%). At variance with the ultrasonic changes seen with the first generation of bioresorbable everolimus drug-eluting vascular scaffold at 6 months, the backscattering of the polymeric struts did not decrease over time, the scaffold area was reduced by only 2.0% with intravascular ultrasound, and no change was noted with OCT. On an intention-to-treat basis, the late lumen loss amounted to 0.19±0.18 mm with a limited relative decrease in minimal luminal area of 5.4% on intravascular ultrasound. OCT showed at follow-up that 96.8% of the struts were covered and that malapposition of at least 1 strut, initially observed in 12 scaffolds, was detected at follow-up in only 3 scaffolds. Mean neointimal growth measured by OCT between and on top of the polymeric struts equaled 1.25 mm(2), or 16.6% of the scaffold area.
  
  
  CONCLUSIONS
  Modified manufacturing process of the polymer and geometric changes in the polymeric platform have substantially improved the medium-term performance of this new generation of drug-eluting scaffold to become comparable to those of current drug eluting stents.
  
  
  BACKGROUND
  URL: http://clinicaltrials.gov. Unique identifier: NCT00856856.
authors.affiliation: ThoraxCenter, Ba-583, 's Gravendijkwal 230, 3015 CE 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: John A
authors.initials: JA
authors.lastname: Ormiston
authors.forename: Bernard
authors.initials: B
authors.lastname: de Bruyne
authors.forename: Evelyn
authors.initials: E
authors.lastname: Regar
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Pieter C
authors.initials: PC
authors.lastname: Smits
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Dougal
authors.initials: D
authors.lastname: McClean
authors.forename: Jacques
authors.initials: J
authors.lastname: Koolen
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: Cécile
authors.initials: C
authors.lastname: Dorange
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.forename: Karine
authors.initials: K
authors.lastname: Miquel-Hebert
authors.forename: Richard
authors.initials: R
authors.lastname: Rapoza
authors.forename: Hector M
authors.initials: HM
authors.lastname: García-García
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000473:pathology* / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000473:pathology; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011108:Polymers; D012189:Retrospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives*; D013997:Time Factors; D054457:Tissue Scaffolds; D041623:Tomography, Optical Coherence / Q000379:methods; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus