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A comparison of an ultrathin strut biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent for patients with acute stsegment elevation myocardial infarction undergoing primary percutaneous coronary intervention: rationale and design of the BIOSTEMI trial
- Publication Year :
- 2018
- Publisher :
- Europa Digital & Publishing, 2018.
-
Abstract
- AIMS A novel ultrathin-strut biodegradable polymer sirolimus-eluting stent (Orsiro™, Biotronik, Bülach, Switzerland; BP-SES) was shown to be superior to a thin-strut durable polymer everolimus-eluting stent (Xience™ Xpedition/Alpine, Abbott Vascular, Santa Clara, USA; DP-EES) with respect to the primary endpoint of target lesion failure (TLF) at 12 months in the prespecified subgroup of patients with ST-segment elevation myocardial infarction (STEMI) included in the BIOSCIENCE trial. We designed a large-scale, randomized, 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. METHODS AND RESULTS BIOSTEMI (NCT02579031) is a prospective, multicentre, randomized, controlled, superiority trial that will randomly assign 1'250 patients with STEMI undergoing primary percutaneous coronary intervention to treatment with BP-SES or DP-EES. The primary endpoint of TLF, a composite of cardiac death, target vessel re-infarction, and clinically-indicated target lesion revascularisation within 12 months, will be analysed with Bayesian models applied to the BIOSTEMI dataset (n=1'250) using robustified historical priors to incorporate historical information from the BIOSCIENCE STEMI subgroup (n=407). CONCLUSIONS 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 primary percutaneous coronary intervention.
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi...........20e0dfcf5a258c77e8ddb52c8b8098c9
- Full Text :
- https://doi.org/10.7892/boris.111057