A comparison of an ultrathin-strut biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent for patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: rationale and design of the BIOSTEMI trial.

Details

Serval ID
serval:BIB_6F2C9D981507
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Title
A comparison of an ultrathin-strut biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent for patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: rationale and design of the BIOSTEMI trial.
Journal
EuroIntervention
Author(s)
Iglesias J.F., Muller O., Zaugg S., Roffi M., Kurz D.J., Vuilliomenet A., Weilenmann D., Kaiser C., Tapponnier M., Heg D., Valgimigli M., Eeckhout E., Jüni P., Windecker S., Pilgrim T.
ISSN
1969-6213 (Electronic)
ISSN-L
1774-024X
Publication state
Published
Issued date
20/08/2018
Peer-reviewed
Oui
Volume
14
Number
6
Pages
692-699
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
A novel ultrathin-strut biodegradable polymer sirolimus-eluting stent (BP-SES) (Orsiro; Biotronik, Bülach, Switzerland) was shown to be superior to a thin-strut durable polymer everolimus-eluting stent (DP-EES) (XIENCE Xpedition/Alpine; Abbott Vascular, Santa Clara, CA, USA) with respect to the primary endpoint of target lesion failure (TLF) at 12 months in the pre-specified subgroup of patients with ST-segment elevation myocardial infarction (STEMI) included in the BIOSCIENCE trial. We designed a large-scale, randomised, clinical trial to assess the clinical superiority of ultrathin-strut BP-SES over thin-strut DP-EES among patients with STEMI undergoing primary percutaneous coronary intervention (PPCI).
BIOSTEMI (NCT02579031) is a prospective, multicentre, randomised, controlled, superiority trial that will randomly assign 1,250 patients with STEMI undergoing PPCI to treatment with BP-SES or DP-EES. The primary endpoint of TLF, a composite of cardiac death, target vessel reinfarction, and clinically indicated target lesion revascularisation within 12 months, will be analysed with Bayesian models applied to the BIOSTEMI data set (n=1,250) using robust historical priors to incorporate historical information from the BIOSCIENCE STEMI subgroup (n=407).
The BIOSTEMI trial will determine whether ultrathin-strut BP-SES are superior to thin-strut DP-EES with respect to TLF in patients with STEMI undergoing PPCI.
Pubmed
Web of science
Create date
07/12/2017 18:57
Last modification date
20/08/2019 14:28
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