title: The edge vascular response following implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold and the XIENCE V metallic everolimus-eluting stent. First serial follow-up assessment at six months and two years: insights from the first-in-man ABSORB Cohort B and SPIRIT II trials.
abstract: OBJECTIVE
  To assess serially the edge vascular response (EVR) of a bioresorbable vascular scaffold (BVS) compared to a metallic everolimus-eluting stent (EES).
  
  
  RESULTS
  Non-serial evaluations of the Absorb BVS at one year have previously demonstrated proximal edge constrictive remodelling and distal edge changes in plaque composition with increase of the percent fibro-fatty (FF) tissue component. The 5 mm proximal and distal segments adjacent to the implanted devices were investigated serially with intravascular ultrasound (IVUS), post procedure, at six months and at two years, from the ABSORB Cohort B1 (n=45) and the SPIRIT II (n=113) trials. Twenty-two proximal and twenty-four distal edge segments were available for analysis in the ABSORB Cohort B1 trial. In the SPIRIT II trial, thirty-three proximal and forty-six distal edge segments were analysed. At the 5-mm proximal edge, the vessels treated with an Absorb BVS from post procedure to two years demonstrated a lumen loss (LL) of 6.68% (-17.33; 2.08) (p=0.027) with a trend toward plaque area increase of 7.55% (-4.68; 27.11) (p=0.06). At the 5-mm distal edge no major changes were evident at either time point. At the 5-mm proximal edge the vessels treated with a XIENCE V EES from post procedure to two years did not show any signs of LL, only plaque area decrease of 6.90% (-17.86; 4.23) (p=0.035). At the distal edge no major changes were evident with regard to either lumen area or vessel remodelling at the same time point.
  
  
  CONCLUSIONS
  The IVUS-based serial evaluation of the EVR up to two years following implantation of a bioresorbable everolimus-eluting scaffold shows a statistically significant proximal edge LL; however, this finding did not seem to have any clinical implications in the serial assessment. The upcoming imaging follow-up of the Absorb BVS at three years is anticipated to provide further information regarding the vessel wall behaviour at the edges.
authors.affiliation: Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Bill D
authors.initials: BD
authors.lastname: Gogas
authors.forename: Christos V
authors.initials: CV
authors.lastname: Bourantas
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Takashi
authors.initials: T
authors.lastname: Muramatsu
authors.forename: Vasim
authors.initials: V
authors.lastname: Farooq
authors.forename: Roberto
authors.initials: R
authors.lastname: Diletti
authors.forename: Robert-Jan M
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Bernard
authors.initials: B
authors.lastname: De Bruyne
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Pieter C
authors.initials: PC
authors.lastname: Smits
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Jacques
authors.initials: J
authors.lastname: Koolen
authors.forename: Stefan
authors.initials: S
authors.lastname: Windecker
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.forename: Dougal
authors.initials: D
authors.lastname: McClean
authors.forename: Cecile
authors.initials: C
authors.lastname: Dorange
authors.forename: Karine
authors.initials: K
authors.lastname: Miquel-Hebert
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.forename: Richard
authors.initials: R
authors.lastname: Rapoza
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D020123:Sirolimus / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000068338:Everolimus; D020123:Sirolimus