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Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: Comparative sequential assessment with optical coherence tomography until complete resorption of the polymer.
MedLine Citation:
PMID:  22093210     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
BACKGROUND: Biolimus-eluting stents (BESs) with a biodegradable polymer in abluminal coating achieve more complete coverage at 9 months compared with sirolimus-eluting stents (SESs) with a durable polymer, as assessed by optical coherence tomography (OCT). Whether this advantage persists or augments after complete resorption of the polymer (>12 months) is unknown.
METHODS: The LEADERS trial compared the performance of BES with that of SES. Patients were randomly allocated to a sequential angiographic follow-up, including OCT in selected sites, at 9 and 24 months. Struts coverage was compared using Bayesian hierarchical models as the primary outcome for the OCT substudy.
RESULTS: Fifty-six patients (26 BES, 30 SES) were enrolled in the OCT substudy. Twenty-one patients (10 BES, 11 SES) agreed to perform a second OCT follow-up at 24 months. Eleven lesions and 12 stents were analyzed sequentially in the BES group (2,455 struts at 9 months, 2,131 struts at 24 months) and 11 lesions and 18 stents in the SES group (3,421 struts at 9 months, 4,170 struts at 24 months). The previously reported advantage of BES over SES in terms of better strut coverage at 9 months was followed by improvement in coverage of the SES, resulting in identical coverage in both BES and SES at 24 months: 1.5% versus 1.8% uncovered struts, difference -0.2%, 95% credibility interval, -3.2% to 2.6%, P = .84.
CONCLUSIONS: More complete strut coverage of BES as compared with SES at 9 months was followed by improvement of coverage in SES between 9 and 24 months and a similar long-term coverage in both stent types at 24 months.
Authors:
Juan Luis Gutiérrez-Chico; Peter Jüni; Héctor M García-García; Evelyn Regar; Eveline Nüesch; Francesco Borgia; Willem J van der Giessen; Simon Davies; Robert Jan van Geuns; Gioel Gabrio Secco; Susanne Meis; Stephan Windecker; Patrick W Serruys; Carlo di Mario
Publication Detail:
Type:  Journal Article     Date:  2011-10-07
Journal Detail:
Title:  American heart journal     Volume:  162     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-11-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  922-31     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2011 Mosby, Inc. All rights reserved.
Affiliation:
Erasmus Medical Centre, Thoraxcentre, Rotterdam, The Netherlands.
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