24-Month BIOSTEMI Results Support Biotronik’s Orsiro DES in STEMI Patients

March 15, 2021—Biotronik announced that 24-month follow-up data were presented from the BIOSTEMI randomized controlled trial evaluating the company’s Orsiro ultrathin-strut drug-eluting stent (DES) for target lesion failure (TLF) in patients presenting with acute ST-segment elevation myocardial infarction (STEMI).

The results were presented by Professor Thomas Pilgrim, MD, in a late-breaking session at CRT 2021, the annual interventional cardiology conference of the Cardiovascular Research Technologies being held as a virtual conference on 10 Saturdays from February 13 to April 24. Additionally, the results were published by Prof. Pilgrim et al in Journal of the American College of Cardiology: Cardiovascular Interventions.

According the company, BIOSTEMI demonstrated the superiority of the Orsiro DES device versus the Xience DES (Abbott) in patients presenting with acute STEMI.

Biotronik stated that 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 TLF at 12 months, which was further confirmed at 24 months with an incidence of 5.1%. By 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. No significant difference was observed between the two treatment arms for safety endpoints, reported Biotronik.

Prof. Pilgrim, Principal Investigator of the trial, commented in Biotronik’s announcement, “In contrast to the primary endpoint data at 1-year, 2-year data show a significant difference between the two treatment arms, not only using Bayesian statistics incorporating a historical prior from the BIOSCIENCE trial, but also when analyzed as an independent clinical trial.” Prof. Pilgrim is with Inselspital Bern, University Hospital in Bern, Switzerland.