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Novel ultrahigh molecular weight amorphous PLLA bioresorbable coronary scaffold upsized up to 0.8 mm beyond nominal diameter: An OCT and histopathology study in porcine coronary artery model
Author(s) -
Gasior Pawel,
Cheng Yanping,
Estrada Edward A.,
Ramzipoor Kamal,
Lee Chang,
Conditt Gerard B.,
Rousselle Serge D.,
Granada Juan F.,
Kaluza Grzegorz L.
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27108
Subject(s) - medicine , stent , elastic recoil , bioresorbable scaffold , artery , balloon , biomedical engineering , restenosis , coronary arteries , percutaneous coronary intervention , nuclear medicine , surgery , cardiology , myocardial infarction , lung
Objectives The aim of the study was to evaluate the biomechanical properties and healing pattern of novel sirolimus‐eluting, ultrahigh molecular weight amorphous poly‐L‐lactic acid bioresorbable scaffolds (S‐BRS) that have been postdilated by 0.55 and 0.8 mm beyond the nominal diameters within the pressure‐diameter compliance chart range. Background Due to the inherent limitations of bioabsorbable polymeric materials, overexpansion/upsizing may be very limited for some BRS such as the benchmark Absorb BVS. The unique biomechanical properties of the novel S‐BRS may allow it to be safely upsized. Methods and Results 12 coronary arteries of 4 healthy Yucatan mini‐swine underwent implantation of a novel S‐BRS. Upsizing by postdilation was performed up to 0.55mm (PLUS 0.55, n = 6) or 0.8 mm (PLUS 0.8, n = 6) in a manner maintaining consistent 1:1.1 stent‐to‐artery, thus ensuring not only the overexpansion of the scaffold but consistent level of arterial injury. Optical coherence tomography (OCT) follow‐up was performed at 28 and 90‐days follow‐up. There was no statistical difference between the tested groups in terms of acute recoil. OCT analysis after 28 days showed numerically lower levels of neointimal formation in PLUS 0.8 compared to PLUS 0.55 group. These results were sustained at 90‐days follow‐up. There was no difference in late recoil between studied groups. No scaffold discontinuation, deformation or overlapping of the struts were observed. Conclusions Overexpansion up to 0.8 mm of novel, high strength S‐BRS is not associated with worse angiographic outcomes, neointimal formation or biomechanical issues such as scaffold discontinuation, deformation or overlapping of the struts, neither acutely nor chronically. © 2017 Wiley Periodicals, Inc.