title: A Polylactide Bioresorbable Scaffold Eluting Everolimus for Treatment of Coronary Stenosis: 5-Year Follow-Up.
abstract: BACKGROUND
  Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown.
  
  
  OBJECTIVE
  This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation.
  
  
  METHODS
  In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging.
  
  
  RESULTS
  Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 ± 19 mm vs. 0.13 ± 0.33 mm; p = 0.7953; B2: 0.23 ± 0.28 mm vs. 0.18 ± 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 ± 0.20 mm versus 0.15 ± 0.24 mm (p = 0.8275) for B1 and 0.30 ± 0.37 mm versus 0.32 ± 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 ± 0.97 mm(2) at 6 months to 4.89 ± 1.81 mm(2) at 5 years (p = 0.04), but remained unchanged in B2 (4.95 ± 0.91 mm(2) at 1 year to 4.84 ± 1.28 mm(2) at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 ± 1.28 mm(2) at 6 months to 3.65 ± 1.39 mm(2) at 5 years (p = 0.01), but remained unchanged in B2, 4.35 ± 1.09 mm(2) at 1 year and 4.12 ± 1.38 mm(2) at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis.
  
  
  CONCLUSIONS
  At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).
authors.affiliation: International Center for Circulatory Health, National Heart and Lung Institute, Imperial College, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: Cardiology Department, Auckland City Hospital, Auckland, New Zealand.
authors.forename: John
authors.initials: J
authors.lastname: Ormiston
authors.affiliation: ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Robert-Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.affiliation: Cardiology Department, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium.
authors.forename: Bernard
authors.initials: B
authors.lastname: de Bruyne
authors.affiliation: Jagiellonian University Institute of Cardiology, University Hospital Krakow, Krakow, Poland.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.affiliation: Department of Cardiology B, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Evald
authors.initials: E
authors.lastname: Christiansen
authors.affiliation: Interventional Cardiology, Institut Hospital Jacques Cartier, Massy, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.affiliation: Cardiologie, Maasstad Ziekenhuis, Rotterdam, the Netherlands.
authors.forename: Pieter
authors.initials: P
authors.lastname: Smits
authors.affiliation: Interventional Cardiology, Christchurch Hospital, Christchurch, New Zealand.
authors.forename: Dougal
authors.initials: D
authors.lastname: McClean
authors.affiliation: Cardiologie, Catharina Ziekenhuis, Eindhoven, the Netherlands.
authors.forename: Jacques
authors.initials: J
authors.lastname: Koolen
authors.affiliation: Universitätsklinik für Kardiologie, Inselspital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Cardiac Catheterisation Lab & Coronary Intervention, Saint Vincent's Hospital Melbourne, Fitzroy, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.affiliation: Monash Heart, Monash Medical Centre, Melbourne, Australia.
authors.forename: Ian
authors.initials: I
authors.lastname: Meredith
authors.affiliation: Clinical Development, Abbott Vascular, Diegem, Belgium.
authors.forename: Luc
authors.initials: L
authors.lastname: Wasungu
authors.affiliation: Clinical Development, Abbott Vascular, Diegem, Belgium.
authors.forename: Divine
authors.initials: D
authors.lastname: Ediebah
authors.affiliation: Clinical Development, Abbott Vascular, Diegem, Belgium.
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.affiliation: ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D002423:Cause of Death / Q000639:trends; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000473:pathology; D054855:Drug-Eluting Stents; D005060:Europe / Q000453:epidemiology; D000068338:Everolimus / Q000494:pharmacology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011091:Polyesters; D011183:Postoperative Complications / Q000453:epidemiology; D011474:Prosthesis Design; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D054457:Tissue Scaffolds; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D007166:Immunosuppressive Agents; D011091:Polyesters; C033616:poly(lactide); D000068338:Everolimus
keywords: angiography; coronary artery disease; follow-up studies; intravascular imaging; long-term; optical coherence; tomography