Five-Year Superiority Proven for Orsiro DES Over Xience DES in STEMI Patients

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.¹ The results have also been published simultaneously in The Lancet.²

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)⁴ 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.⁶ STEMI patients represent about 30% of all primary percutaneous coronary intervention (PCI) cases.⁷

“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.”

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References: 

¹ Iglesias, JF. Long-Term Outcomes with Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With ST-Segment Elevation Myocardial Infarction: 5-Year Follow-up of the Biostemi Randomized Trial. Presented at: TCT 2023; October 25, 2023; San Francisco, USA.

² Iglesias, JF et al. Long-term outcomes with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomized superiority trial, The Lancet, 2023 doi.org/10.1016/S0140-6736(23)02197-9

³ Target lesion failure is a combined endpoint of cardiac death, target vessel myocardial reinfarction, and ischemia-driven target lesion revascularization, representing measures of safety and efficacy.

⁴ 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, randomized superiority trial, The Lancet, 2019

⁵ Pilgrim T. et al. Biodegradable- versus durable-polymer drug-eluting stents for STEMI – Final 2-year outcomes of the BIOSTEMI trial, JACC Cardiovascular Interventions, 2021

⁶ Vogel B et al. ST-segment elevation myocardial infarction; Nature Reviews Disease Primers. 2019; 5(1):39.

⁷ Fokkema ML et al. Outcome after percutaneous coronary intervention for different indications: long-term results from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). EuroIntervention. 2016; 12(3):303-11.

Orsiro and Orsiro Mission DES are not indicated for STEMI patients in the United States.

Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owners.

For more information visit: Orsiro DES