Document Detail

The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer.
MedLine Citation:
PMID:  20562074     Owner:  NLM     Status:  MEDLINE    
AIMS: This study reports the 12-month clinical outcomes of the LEADERS clinical trial which compared a biolimus eluting stent with a biodegradable polymer (BES) to a sirolimus eluting stent with a durable polymer (SES).
METHODS AND RESULTS: The multicentre LEADERS trial employed an all-comers approach to recruit 1,707 patients who were randomised to treatment with either BES (n=857) or SES (n=850) in a non-inferiority design. The primary clinical endpoint of this study was a composite of cardiac death, myocardial infarction and clinical-indicated target vessel revascularisation. Follow-up was obtained in 97.6% of patients. At 12 months, BES remained non-inferior compared to SES for the primary endpoint (BES 10.6% vs. SES 12.0%, HR:0.88, 95% CI:0.66-1.17, p=0.37). Rates of cardiac death (2.1% vs. 2.7%, HR:0.77, 95% CI:0.42-1.44, p=0.42), MI (5.8% vs. 4.6%, HR:1.27, 95% CI:0.84-1.94, p=0.26) and clinically-indicated target vessel revascularisation (5.8% vs. 7.1%, HR:0.82, 95%CI:0.56-1.19, p=0.29) were similar for BES and SES. Similarly, there was no difference in the incidence of definite stent thrombosis at 12 months.
CONCLUSIONS: These findings support the safety and efficacy of the BES stent with a biodegradable polymer at 12-month clinical follow-up, and suggest it is a suitable alternative to the SES stent with a durable polymer.
Scot Garg; Giovanna Sarno; Patrick W Serruys; Ton de Vries; Pawel Buszman; Axel Linke; Thomas Ischinger; Volker Klauss; Franz Eberli; Roberto Corti; William Wijns; Marie-Claude Morice; Carlo Di Mario; Robert Jan van Geuns; Pedro Eerdmans; Gerrit-Anne van Es; Bernhard Meier; Peter Jüni; Stephan Windecker
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology     Volume:  6     ISSN:  1969-6213     ISO Abbreviation:  EuroIntervention     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-06-21     Completed Date:  2010-12-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  France    
Other Details:
Languages:  eng     Pagination:  233-9     Citation Subset:  IM    
Department of Interventional Cardiology, Erasmus MC, Rotterdam, The Netherlands.
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MeSH Terms
Absorbable Implants
Drug-Eluting Stents*
Follow-Up Studies
Lactic Acid
Middle Aged
Prospective Studies
Sirolimus / administration & dosage*,  analogs & derivatives*
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Biolimus A9; 0/Polymers; 26100-51-6/poly(lactic acid); 50-21-5/Lactic Acid; 53123-88-9/Sirolimus

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