Superiority of Orsiro stent over Xience demonstrated in STEMI patients: late-breaking data at ESC.- Biotronik

BIOTRONIK�s ultrathin Orsiro stent demonstrated superiority over Xience with respect to target lesion failure (TLF) at 12 months, according to newly released data from the BIOSTEMI trial. Dr. Juan Fernando Iglesias, Geneva University Hospitals, Geneva, Switzerland unveiled the results of the randomized controlled trial (RCT) in a late-breaking session at the ESC congress. The results have also been published in The Lancet.

BIOSTEMI is the first direct comparison between two newer-generation drug-eluting stents (DES) in patients presenting with acute ST-segment elevation myocardial infarction (STEMI). BIOSTEMI is also the first RCT to demonstrate superiority between two contemporary DES. �The BIOSTEMI trial proves what the BIOSCIENCE STEMI subgroup analysis had already suggested: Different platform designs can really make a difference,� explained Principal Investigator, Dr. Iglesias. �Based on the data, compared to the Xience stent, Orsiro is a superior solution for STEMI patients. In this patient group, vascular healing is a challenge due to the complex pro-thrombotic and inflammatory milieu. With Orsiro, we can incrementally improve their care path.�

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.3 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. Orsiro demonstrated superiority in the clinical primary endpoint of TLF5 with an incidence of 4%, in comparison to Xience, with an incidence of 6% at 12 months (Rate Ratio 0.59, 95% Bayesian credible interval, 0.37-0.94; posterior probability of superiority, 98.6%). The difference in TLF was driven by lower rates of clinically-indicated target lesion revascularization in patients treated with ultrathin Orsiro compared to Xience. .

See- Iglesias JF et al. "Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial ". The Lancet. Published online: Sep 2, 2019. DOI: https://doi.org/10.1016/S0140-6736(19)31877-X.