title: Four-year polymer biocompatibility and vascular healing profile of a novel ultrahigh molecular weight amorphous PLLA bioresorbable vascular scaffold: an OCT study in healthy porcine coronary arteries.
abstract: The vascular healing profile of polymers used in bioresorbable vascular scaffolds (BRS) has not been fully characterised in the absence of antiproliferative drugs. In this study, we aimed to compare the polymer biocompatibility profile and vascular healing response of a novel ultrahigh molecular weight amorphous PLLA BRS (FORTITUDE®; Amaranth Medical, Mountain View, CA, USA) against bare metal stent (BMS) controls in porcine coronary arteries.
  
  
  
  Following device implantation, optical coherence tomography (OCT) evaluation was performed at 0 and 28 days, and at one, two, three and four years. A second group of animals underwent histomorphometric evaluation at 28 and 90 days. At four years, both lumen (BRS 13.19±1.50 mm2 vs. BMS 7.69±2.41 mm2) and scaffold areas (BRS 15.62±1.95 mm2 vs. BMS 8.65±2.37 mm2) were significantly greater for BRS than BMS controls. The degree of neointimal proliferation was comparable between groups. Histology up to 90 days showed comparable healing and inflammation profiles for both devices.
  
  
  
  At four years, the novel PLLA BRS elicited a vascular healing response comparable to BMS in healthy pigs. Expansive vascular remodelling was evident only in the BRS group, a biological phenomenon that appears to be independent of the presence of antiproliferative drugs.
authors.affiliation: CRF-Skirball Center for Innovation, New York, NY, USA.
authors.forename: Torsten P
authors.initials: TP
authors.lastname: Vahl
authors.forename: Pawel
authors.initials: P
authors.lastname: Gasior
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Gongora
authors.forename: Kamal
authors.initials: K
authors.lastname: Ramzipoor
authors.forename: Chang
authors.initials: C
authors.lastname: Lee
authors.forename: Yanping
authors.initials: Y
authors.lastname: Cheng
authors.forename: Jenn
authors.initials: J
authors.lastname: McGregor
authors.forename: Masahiko
authors.initials: M
authors.lastname: Shibuya
authors.forename: Edward A
authors.initials: EA
authors.lastname: Estrada
authors.forename: Gerard B
authors.initials: GB
authors.lastname: Conditt
authors.forename: Greg L
authors.initials: GL
authors.lastname: Kaluza
authors.forename: Juan F
authors.initials: JF
authors.lastname: Granada
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects; D000818:Animals; D017023:Coronary Angiography / Q000379:methods; D003331:Coronary Vessels / Q000473:pathology / Q000601:surgery*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D023421:Models, Animal; D008970:Molecular Weight; D058426:Neointima / Q000473:pathology*; D011108:Polymers / Q000009:adverse effects; D013552:Swine; D041623:Tomography, Optical Coherence / Q000379:methods
chemical_list: D011108:Polymers