Permanent URL to this publication: http://dx.doi.org/10.5167/uzh-44641
Garg, S; Sarno, G; Serruys, P W; de Vries, T; Buszman, P; Linke, A; Ischinger, T; Klauss, V; Eberli, F; Corti, R; Wijns, W; Morice, M C; Di Mario, C; van Geuns, R J; Eerdmans, P; van Es, G A; Meier, B; Jüni, P; Windecker, S (2010). The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer. EuroIntervention, 6(2):233-239.
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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.
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|Item Type:||Journal Article, refereed, original work|
|Communities & Collections:||04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiology|
|DDC:||610 Medicine & health|
|Deposited On:||04 Feb 2011 18:16|
|Last Modified:||27 May 2014 12:15|
|Publisher:||Société Europa édition|
|Related URLs:||http://www.pcronline.com/eurointervention/28th_issue/ (Publisher)|
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