Document Detail


Head-to-head comparison of the neointimal response between metallic and bioresorbable everolimus-eluting scaffolds using optical coherence tomography.
MedLine Citation:
PMID:  22192368     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: This study sought to compare the neointimal response of metallic everolimus drug-eluting stents (DES) and polymeric everolimus bioresorbable vascular scaffolds (BVS) by optical coherence tomography at 1 year.
BACKGROUND: DES decrease the risk of restenosis by reducing the neointimal response. However, DES may impair strut coverage, and this has been associated with late stent/scaffold thrombosis. BVS may overcome the risk of stent/scaffold thrombosis when completely resorbed. It is unknown if, during the bioresorption process, the neointimal response of the everolimus BVS (Absorb, Abbott Vascular, Santa Clara, California) differs from that of the metallic everolimus DES (Xience, Abbott Vascular).
METHODS: A total of 19 lesions were treated with a single everolimus DES, and 31 lesions were treated with everolimus BVS and imaged with optical coherence tomography at 1 year. Neointimal response was assessed as percentage of uncovered struts, neointimal thickness, in-stent/scaffold area obstruction, and pattern of neointima.
RESULTS: At 1 year, no significant differences in the angiographic lumen loss were seen for the everolimus DES and everolimus BVS (0.18 ± 0.20 mm vs. 0.29 ± 0.36 mm; p = 0.42). optical coherence tomography analysis of 951 cross sections and 8,385 struts demonstrated similar rates of uncovered struts (5.3% everolimus DES vs. 4.5% everolimus BVS; p = 0.11), mean neointimal thickness (120.6 ± 46.0 μm vs. 136.1 ± 71.4 μm; p = 0.82) and in-stent/scaffold area obstruction (12.5 ± 7.1% vs. 13.6 ± 9.7%; p = 0.91), respectively. There was a trend of higher heterogenic tissue pattern of neointima (21.1% vs. 6.5%; p = 0.12) and less intraluminal masses (0% vs. 12.9%; p = 0.10) with everolimus DES than with everolimus BVS.
CONCLUSIONS: The everolimus BVS (Absorb) demonstrated a similar neointimal response as the everolimus DES (Xience). However, the presence of intraluminal masses at 12 months in a small proportion of patients warranted watchful follow-up of these cases.
Authors:
Josep Gomez-Lara; Salvatore Brugaletta; Vasim Farooq; Yoshinobu Onuma; Roberto Diletti; Stephan Windecker; Leif Thuesen; Dougal McClean; Jacques Koolen; Robert Whitbourn; Dariusz Dudek; Pieter C Smits; Bernard Chevalier; Evelyn Regar; Susan Veldhof; Richard Rapoza; John A Ormiston; Hector M Garcia-Garcia; Patrick W Serruys
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Publication Detail:
Type:  Clinical Trial, Phase I; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  4     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2011 Dec 
Date Detail:
Created Date:  2011-12-23     Completed Date:  2012-04-23     Revised Date:  2014-09-05    
Medline Journal Info:
Nlm Unique ID:  101467004     Medline TA:  JACC Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1271-80     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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MeSH Terms
Descriptor/Qualifier:
Absorbable Implants*
Aged
Angioplasty, Balloon, Coronary / adverse effects,  instrumentation*
Cardiovascular Agents / administration & dosage*
Chi-Square Distribution
Coronary Angiography
Coronary Artery Disease / diagnosis,  therapy*
Coronary Stenosis / diagnosis,  etiology,  pathology,  prevention & control*
Coronary Vessels / pathology*
Drug-Eluting Stents*
Female
Humans
Male
Metals*
Middle Aged
Predictive Value of Tests
Prosthesis Design
Sirolimus / administration & dosage,  analogs & derivatives*
Time Factors
Tomography, Optical Coherence*
Treatment Outcome
Tunica Intima / pathology*
Chemical
Reg. No./Substance:
0/Cardiovascular Agents; 0/Metals; 159351-69-6/everolimus; W36ZG6FT64/Sirolimus

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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