Document Detail

Long-Term Safety of an Everolimus-Eluting Bioresorbable Vascular Scaffold and the Cobalt-Chromium XIENCE V Stent in a Porcine Coronary Artery Model.
MedLine Citation:
PMID:  24895447     Owner:  NLM     Status:  Publisher    
BACKGROUND: The Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb) has shown promising clinical results; however, only limited preclinical data have been published. We sought to investigate detailed pathological responses to the Absorb versus XIENCE V (XV) in a porcine coronary model with duration of implant extending from 1 to 42 months.
METHODS AND RESULTS: A total of 335 devices (263 Absorb and 72 XV) were implanted in 2 or 3 main coronary arteries of 136 nonatherosclerotic swine and examined by light microscopy, scanning electron microscopy, pharmacokinetics, and gel permeation chromatography analyses at various time points. Vascular responses to Absorb and XV were largely comparable at all time points, with struts being sequestered within the neointima. Inflammation was mild to moderate (with absence of inflammation at 1 month) for both devices, although the scores were greater in Absorb at 6 to 36 months. Percent area stenosis was significantly greater in Absorb than XV at all time points except at 3 months. The extent of fibrin deposition was similar between Absorb and XV, which peaked at 1 month and decreased rapidly thereafter. Histomorphometry showed expansile remodeling of Absorb-implanted arteries starting after 12 months, and lumen area was significantly greater in Absorb than XV at 36 and 42 months. These changes correlated with dismantling of Absorb seen after 12 months. Gel permeation chromatography analysis confirmed that degradation of Absorb was complete by 36 months.
CONCLUSIONS: Absorb demonstrates comparable long-term safety to XV in porcine coronary arteries with mild to moderate inflammation. Although Absorb was associated with greater percent stenosis relative to XV, expansile remodeling was observed after 12 months in Absorb with significantly greater lumen area at ≥36 months. Resorption is considered complete at 36 months.
Fumiyuki Otsuka; Erica Pacheco; Laura E L Perkins; Jennifer P Lane; Qing Wang; Marika Kamberi; Michael Frie; Jin Wang; Kenichi Sakakura; Kazuyuki Yahagi; Elena Ladich; Richard J Rapoza; Frank D Kolodgie; Renu Virmani
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-6-3
Journal Detail:
Title:  Circulation. Cardiovascular interventions     Volume:  -     ISSN:  1941-7632     ISO Abbreviation:  Circ Cardiovasc Interv     Publication Date:  2014 Jun 
Date Detail:
Created Date:  2014-6-4     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101499602     Medline TA:  Circ Cardiovasc Interv     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2014 American Heart Association, Inc.
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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