Final BIOSTEMI Data Confirmed Better Target Lesion Failure Rates for BIOTRONIK’s Orsiro Drug-Eluting Stent
Orsiro Drug-Eluting Stent
Five-year-data from the BIOSTEMI trial confirmed the superiority of BIOTRONIK’s Orsiro® drug-eluting stent (DES) over Xience DES in patients with acute ST-segment elevation myocardial infarction (STEMI). Dr. Juan F. Iglesias, Geneva University Hospitals, Geneva, Switzerland presented the final study data in a late-breaking clinical science session at the TCT conference. The results have also been published simultaneously in The Lancet.
BIOSTEMI is an investigator-initiated, multicenter, superiority trial. Using the Bayesian design, it compares the safety and efficacy of the biodegradable-polymer, sirolimus-eluting Orsiro stent to the durable-polymer, everolimus-eluting Xience stent. The trial included 1,300 patients with acute myocardial infarction.
For the clinical primary endpoint of target lesion failure (TLF)3 at five years, Orsiro DES demonstrated superiority 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 already demonstrated the superiority of the Orsiro DES in STEMI patients. The significant difference was initially demonstrated at one year (TLF of 4% for Orsiro vs. 6% for Xience) and confirmed at the two-year final follow-up (TLF of 5.1% for Orsiro vs. 8.1% for Xience)5. The results triggered an extension study, BIOSTEMI ES, to assess the long-term clinical outcomes with the Orsiro stent compared to the Xience stent up to five 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.” Dr. Juan F. Iglesias, Geneva University Hospitals, Geneva, Switzerland. “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.”
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.
“While most stent-comparing trials are non-inferiority trials, the BIOSTEMI study demonstrated Orsiro DES' long-term superiority for STEMI patients,” said Stuart Perks, Vice President of Marketing, Vascular Intervention at BIOTRONIK. “The results further underline the relevance of our ultrathin strut DES in this large and challenging patient group.”