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 Paper/Review - Aug 20, 2018
Iglesias Juan F, Muller Olivier, Zaugg Serge, Roffi Marco, Kurz David J, Vuilliomenet André, Weilenmann Daniel, Kaiser Christoph, Tapponnier Maxime, Heg Dik, Valgimigli Marco, Eeckhout Eric, Jüni Peter, Windecker Stephan, Pilgrim Thomas
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).
METHODS AND RESULTS
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.