title: Scaffold and edge vascular response following implantation of everolimus-eluting bioresorbable vascular scaffold: a 3-year serial optical coherence tomography study.
abstract: OBJECTIVE
  This study sought to investigate the in-scaffold vascular response (SVR) and edge vascular response (EVR) after implantation of an everolimus-eluting bioresorbable scaffold (BRS) using serial optical coherence tomography (OCT) imaging.
  
  
  BACKGROUND
  Although studies using intravascular ultrasound have evaluated the EVR in metal stents and BRSs, there is a lack of OCT-based SVR and EVR assessment after BRS implantation.
  
  
  METHODS
  In the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study, 23 patients (23 lesions) in Cohort B1 and 17 patients (18 lesions) in Cohort B2 underwent truly serial OCT examinations at 3 different time points (Cohort B1: post-procedure, 6 months, and 2 years; B2: post-procedure, 1 year, and 3 years) after implantation of an 18-mm scaffold. A frame-by-frame OCT analysis was performed at the 5-mm proximal, 5-mm distal edge, and 2-mm in-scaffold margins, whereas the middle 14-mm in-scaffold segment was analyzed at 1-mm intervals.
  
  
  RESULTS
  The in-scaffold mean luminal area significantly decreased from baseline to 6 months or 1 year (7.22 ± 1.24 mm(2) vs. 6.05 ± 1.38 mm(2) and 7.64 ± 1.19 mm(2) vs. 5.72 ± 0.89 mm(2), respectively; both p < 0.01), but remained unchanged from then onward. In Cohort B1, a significant increase in mean luminal area of the distal edge was observed (5.42 ± 1.81 mm(2) vs. 5.58 ± 1.53 mm(2); p < 0.01), whereas the mean luminal area of the proximal edge remained unchanged at 6 months. In Cohort B2, the mean luminal areas of the proximal and distal edges were significantly smaller than post-procedure measurements at 3 years. The mean luminal area loss at both edges was significantly less than the mean luminal area loss of the in-scaffold segment at both 6-month and 2-year follow-up in Cohort B1 or at 1 year and 3 years in Cohort B2.
  
  
  CONCLUSIONS
  This OCT-based serial EVR and SVR evaluation of the Absorb Bioresorbable Vascular Scaffold (Abbott Vascular, Santa Clara, California) showed less luminal loss at the edges than luminal loss within the scaffold. The luminal reduction of both edges is not a nosologic entity, but an EVR in continuity with the SVR, extending from the in-scaffold margin to both edges. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
authors.forename: Yao-Jun
authors.initials: YJ
authors.lastname: Zhang
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Department of Cardiovascular Science, University of Sheffield, Sheffield, United Kingdom.
authors.forename: Javaid
authors.initials: J
authors.lastname: Iqbal
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Shimpei
authors.initials: S
authors.lastname: Nakatani
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Christos V
authors.initials: CV
authors.lastname: Bourantas
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Carlos M
authors.initials: CM
authors.lastname: Campos
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Ishibashi
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Yun-Kyeong
authors.initials: YK
authors.lastname: Cho
authors.affiliation: Abbott Vascular, Diegem, Belgium.
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.affiliation: Abbott Vascular, Diegem, Belgium.
authors.forename: Jin
authors.initials: J
authors.lastname: Wang
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.affiliation: Jagiellonian University, Krakow, Poland.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Robert-Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom. Electronic address: p.w.j.c.serruys@gmail.com.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology; D003328:Coronary Thrombosis / Q000175:diagnosis / Q000209:etiology; D003331:Coronary Vessels / Q000473:pathology*; D000068338:Everolimus; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D000068338:Everolimus; D020123:Sirolimus
keywords: Absorb BVS; bioresorbable scaffold; edge vascular response; in-scaffold vascular response; optical coherence tomography