title: First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study.
abstract: BACKGROUND
  Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes.
  
  
  RESULTS
  The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm(2) on optical coherence tomography and 0.17±0.26 mm(2) on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm(2) on intravascular ultrasound, P=0.003 and 0.77±1.33 m(2) on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis.
  
  
  CONCLUSIONS
  This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.
authors.affiliation: Auckland City Hospital, Auckland, New Zealand.
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Robert-Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Bernard
authors.initials: B
authors.lastname: de Bruyne
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: 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: Richard
authors.initials: R
authors.lastname: Rapoza
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D001315:Australia; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology; D003328:Coronary Thrombosis / Q000175:diagnosis / Q000209:etiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000473:pathology / Q000503:physiopathology; D003952:Diagnostic Imaging / Q000379:methods; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima; D009520:New Zealand; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D054457:Tissue Scaffolds; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D000068338:Everolimus; D020123:Sirolimus