title: Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb Everolimus-Eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions).
abstract: OBJECTIVE
  This study sought to describe the frequency and clinical impact of acute scaffold disruption and late strut discontinuity of the second-generation Absorb bioresorbable polymeric vascular scaffolds (Absorb BVS, Abbott Vascular, Santa Clara, California) in the ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) cohort B study by optical coherence tomography (OCT) post-procedure and at 6, 12, 24, and 36 months.
  
  
  BACKGROUND
  Fully bioresorbable scaffolds are a novel approach to treatment for coronary narrowing that provides transient vessel support with drug delivery capability without the long-term limitations of metallic drug-eluting stents. However, a potential drawback of the bioresorbable scaffold is the potential for disruption of the strut network when overexpanded. Conversely, the structural discontinuity of the polymeric struts at a late stage is a biologically programmed fate of the scaffold during the course of bioresorption.
  
  
  METHODS
  The ABSORB cohort B trial is a multicenter single-arm trial assessing the safety and performance of the Absorb BVS in the treatment of 101 patients with de novo native coronary artery lesions. The current analysis included 51 patients with 143 OCT pullbacks who underwent OCT at baseline and follow-up. The presence of acute disruption or late discontinuities was diagnosed by the presence on OCT of stacked, overhung struts or isolated intraluminal struts disconnected from the expected circularity of the device.
  
  
  RESULTS
  Of 51 patients with OCT imaging post-procedure, acute scaffold disruption was observed in 2 patients (3.9%), which could be related to overexpansion of the scaffold at the time of implantation. One patient had a target lesion revascularization that was presumably related to the disruption. Of 49 patients without acute disruption, late discontinuities were observed in 21 patients. There were no major adverse cardiac events associated with this finding except for 1 patient who had a non-ischemia-driven target lesion revascularization.
  
  
  CONCLUSIONS
  Acute scaffold disruption is a rare iatrogenic phenomenon that has been anecdotally associated with anginal symptoms, whereas late strut discontinuity is observed in approximately 40% of patients and could be viewed as a serendipitous OCT finding of a normal bioresorption process without clinical implications. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).
authors.affiliation: Department of Interventional Cardiology, ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Department of Interventional Cardiology, ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: patrick.w.j.c.serruys@gmail.com.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: Department of Interventional Cardiology, ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Takashi
authors.initials: T
authors.lastname: Muramatsu
authors.affiliation: Department of Interventional Cardiology, ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Shimpei
authors.initials: S
authors.lastname: Nakatani
authors.affiliation: Department of Interventional Cardiology, ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Robert-Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.affiliation: Department of Interventional Cardiology, Cardiovascular Center, Aalst, Belgium.
authors.forename: Bernard
authors.initials: B
authors.lastname: de Bruyne
authors.affiliation: Department of Cardiology and Cardiovascular Interventions, Jagiellonian University, Krakow, Poland.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.affiliation: Department of Cardiology, Skejby Sygehus University Hospital, Aarhus, Denmark.
authors.forename: Evald
authors.initials: E
authors.lastname: Christiansen
authors.affiliation: Department of Interventional Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.
authors.forename: Pieter C
authors.initials: PC
authors.lastname: Smits
authors.affiliation: Institut Cardiovasculaire Paris Sud, Institut Jacques Cartier, Massy, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.affiliation: Department of Interventional Cardiology, Christchurch Hospital, Christchurch, New Zealand.
authors.forename: Dougal
authors.initials: D
authors.lastname: McClean
authors.affiliation: Department of Interventional Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
authors.forename: Jacques
authors.initials: J
authors.lastname: Koolen
authors.affiliation: Department of Interventional Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Cardiac Investigation Unit, St. Vincents Hospital, Fitzroy, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.affiliation: Department of Medicine, Cardiology, Monash Cardiovascular Research Centre, Melbourne, Australia.
authors.forename: Ian
authors.initials: I
authors.lastname: Meredith
authors.affiliation: Department of Interventional Cardiology, Cardialysis, Rotterdam, the Netherlands.
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.affiliation: Department of Clinical Research, Abbott Vascular, Diegem, Belgium.
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.affiliation: Research and Development, Abbott Vascular, Santa Clara, California.
authors.forename: Richard
authors.initials: R
authors.lastname: Rapoza
authors.affiliation: Department of Interventional Cardiology, Auckland City Hospital, Auckland, New Zealand.
authors.forename: John A
authors.initials: JA
authors.lastname: Ormiston
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D008297:Male; 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; D000068338:Everolimus; D020123:Sirolimus
keywords: atherosclerosis; biodegradable polymer; bioresorbable scaffold; everolimus; stent