Biotronik’s Orsiro DES for STEMI Evaluated at 5-Years in BIOSTEMI

October 26, 2023—Biotronik announced that 5-year data from the BIOSTEMI trial confirmed the superiority of the company’s Orsiro drug-eluting stent (DES) versus a durable polymer everolimus-eluting stent (DP-EES) for patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

BIOSTEMI is an investigator-initiated, multicenter, superiority trial composed of 1,300 patients with acute myocardial infarction. Using the Bayesian design, it compares the safety and efficacy of the biodegradable-polymer, sirolimus-eluting Orsiro stent to the DP-EES (Xience, Abbott). The Orsiro and Orsiro Mission DES are not indicated for STEMI patients in the United States, advised Biotronik.

Juan F. Iglesias, MD, of the Geneva University Hospitals in Geneva, Switzerland, presented the final study data in a late-breaking clinical science session at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California. The results were published simultaneously by Dr. Iglesias et al in The Lancet.

According to Biotronik, Orsiro DES demonstrated superiority for the clinical primary endpoint of target lesion failure (TLF) at 5 years with an incidence of 7.7% compared to Xience DES with an incidence of 11.1% (posterior probability of superiority, 98.8%). This difference was mainly driven by a numerically lower risk for ischemia-driven target lesion revascularization for the Orsiro ultrathin strut DES.

The BIOSTEMI randomized controlled trial previously demonstrated the superiority of the Orsiro DES versus Xience in STEMI patients (TLF, 4% vs 6%) in 1-year data that was presented and published in 2019 and confirmed in 2-year final follow-up data (TLF, 5.1% vs 8.1%) that were presented and published in 2021.

Those results triggered an extension study, BIOSTEMI Extended Survival (ES), to assess the long-term clinical outcomes with the Orsiro stent compared to the Xience stent up to 5 years.

“The BIOSTEMI ES study is truly unique as it is the first head-to-head randomized trial with a superiority design and long-term follow-up demonstrating significant differences between two contemporary DES for the treatment of patients with STEMI,” commented Dr. Iglesias. “Another unique characteristic of this trial is the absence of late catch-up phenomenon with newer-generation biodegradable polymer DES after complete degradation of the polymer coating.”