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.

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.