Quick Search:

uzh logo
Browse by:
bullet
bullet
bullet
bullet

Zurich Open Repository and Archive

Permanent URL to this publication: http://dx.doi.org/10.5167/uzh-61261

Klauss, V; Serruys, P W; Pilgrim, T; Buszman, P; Linke, A; Ischinger, T; Eberli, F; Corti, R; Wijns, W; Morice, M; di Mario, C; van Geuns, R; van Es, G; Kalesan, B; Wenaweser, P; Jüni, P; Windecker, S (2011). 2-year clinical follow-up from the randomized comparison of biolimus-eluting stents with biodegradable polymer and sirolimus-eluting stents with durable polymer in routine clinical practice. JACC: Cardiovascular Interventions, 4(8):887-895.

[img]Published Version
PDF - Registered users only
1MB

View at publisher

Abstract

Objectives:
This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with sirolimus-eluting stents (SES) with durable polymer through 2 years of follow-up.

Background:
BES with a biodegradable polymer provide similar efficacy and safety as SES with a durable polymer at 9 months. Clinical outcomes beyond the period of biodegradation of the polymer used for drug release and after discontinuation of dual antiplatelet therapy are of particular interest.

Methods:
A total of 1,707 patients were randomized to unrestricted use of BES (n = 857) or SES (n = 850) in an all-comers patient population.

Results:
At 2 years, BES remained noninferior compared with SES for the primary endpoint, which was a composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularization (BES 12.8% vs. SES 15.2%, hazard ratio [HR]: 0.84, 95% confidence interval [CI]: 0.65 to 1.08, pnoninferiority < 0.0001, psuperiority = 0.18). Rates of cardiac death (3.2% vs. 3.9%, HR: 0.81, 95% CI: 0.49 to 1.35, p = 0.42), myocardial infarction (6.3% vs. 5.6%, HR: 1.12, 95% CI: 0.76 to 1.65, p = 0.56), and clinically indicated target vessel revascularization (7.5% vs. 8.6%, HR: 0.86, 95% CI: 0.62 to 1.20, p = 0.38) were similar for BES and SES. The rate of definite stent thrombosis through 2 years was 2.2% for BES and 2.5% for SES (p = 0.73). For the period between 1 and 2 years, event rates for definite stent thrombosis were 0.2% for BES and 0.5% for SES (p = 0.42). After discontinuation of dual antiplatelet therapy, no very late definite stent thrombosis occurred in the BES group.

Conclusions:
At 2 years of follow-up, the unrestricted use of BES with a biodegradable polymer maintained a similar safety and efficacy profile as SES with a durable polymer. (Limus Eluted From a Durable Versus Erodable Stent Coating [LEADERS]; NCT00389220)

Citations

12 citations in Web of Science®
13 citations in Scopus®
Google Scholar™

Altmetrics

Downloads

0 downloads since deposited on 15 Mar 2012
0 downloads since 12 months

Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiology
DDC:610 Medicine & health
Language:English
Date:2011
Deposited On:15 Mar 2012 14:16
Last Modified:28 Nov 2013 05:57
Publisher:Elsevier
ISSN:1876-7605
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:10.1016/j.jcin.2011.03.017
PubMed ID:21851904

Users (please log in): suggest update or correction for this item

Repository Staff Only: item control page