Superiority of Orsiro DES over Xience DES confirmed in STEMI patients according to new follow-up data from the BIOSTEMI trial.- Biotronik.

Biotronik’s ultrathin-strut stent, Orsiro, demonstrated superiority over Xience DES for target lesion failure (TLF) at 24 months, according to new follow-up data from the BIOSTEMI trial. The latest results were presented by Prof. Thomas Pilgrim, Inselspital Bern, University Hospital, Bern, Switzerland, who unveiled them in a late-breaking session at CRT 2021. The results of this randomized controlled trial have also been published in JACC Cardiovascular Interventions. Most drug eluting stent trials are powered only to demonstrate non-inferiority. BIOSTEMI is a rare trial that demonstrates the superiority between two contemporary DES in patients presenting with acute ST-segment elevation myocardial infarction (STEMI). Caused by a complete thrombotic occlusion in a coronary vessel, STEMI is the most acute manifestation of coronary artery disease, with substantial rates of morbidity and mortality. STEMI patients represent about 30% of all primary percutaneous coronary intervention (PCI) cases. BIOSTEMI is an investigator-initiated, multicenter, superiority trial, using a Bayesian design, to compare biodegradable-polymer, sirolimus-eluting stents to durable-polymer, everolimus-eluting stents in 1,300 patients with acute myocardial infarction. The ultrathin-strut Orsiro DES demonstrated superiority in the clinical primary endpoint of TLF5 at 12 months, which was further confirmed at 24 months with an incidence of 5.1%. In comparison, the Xience DES, showed an incidence of 8.1% at 24 months (Rate Ratio 0.58, 95% Bayesian credible interval, 0.40-0.84; posterior probability of superiority, 99.8%). The difference remained significant after the exclusion of historical data from the BIOSCIENCE trial with only the BIOSTEMI patients being analyzed (Rate Ratio 0.62, 95% Bayesian credible interval, 0.40-0.96; posterior probability of superiority, 98.5%). The difference was driven by a lower incidence of clinically indicated, target lesion revascularization (TLR). No significant difference was observed between the two treatment arms for safety endpoints. See- Pilgrim et al." Biodegradable – versus durable-polymer drug-eluting stents for STEMI. Final 2-year outcomes of the BIOSTEMI trial". J Am Coll Cardiol. Cardiovasc Interven. 2021, doi: 10.1016/j.jcin.2020.12.011.