Superiority of Orsiro DES Over Xience DES Confirmed in STEMI Patients
In the BIOSTEMI clinical trial, powered for superiority, Orsiro is confirmed as the superior drug-eluting stent (DES) for STEMI at two-year follow-up
BIOTRONIK’s ultrathin-strut stent, Orsiro®*, demonstrated superiority over Xience DES for target lesion failure (TLF) at 24 months, according to new follow-up data from the BIOSTEMI trial.1
The latest results were presented by Prof. Thomas Pilgrim, Inselspital Bern, University Hospital, Bern, Switzerland, who unveiled them in a late-breaking session at CRT 2021. The results of this randomized controlled trial have also been published in JACC Cardiovascular Interventions.2
Most drug eluting stent trials are powered only to demonstrate non-inferiority. BIOSTEMI is a rare trial that demonstrates the superiority between two contemporary DES in patients presenting with acute ST-segment elevation myocardial infarction (STEMI).
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.4
“In contrast to the primary endpoint data at one-year, two-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,” explained Principal Investigator Prof. Pilgrim.
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 TLF5 at 12 months, which was further confirmed at 24 months with an incidence of 5.1%. In 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 (TLR). No significant difference was observed between the two treatment arms for safety endpoints.
“The BIOSTEMI outcomes at 24 months demonstrate the unequivocal superiority of ultrathin strut Orsiro DES over Xience DES,” commented Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK. “In my opinion this data should define a new standard of care in the treatment of STEMI patients, what would you choose for your heart?"
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1 Pilgrim T, Randomized Comparison Of Biodegradable Polymer Sirolimus-eluting Stents Versus Durable Polymer Everolimus-eluting Stents In Patients With ST-segment Elevation Myocardial Infarction: Final 2-year Outcomes Of The BIOSTEMI Randomized Trial. Presented at virtual CRT2021, March 13, 2021.
2 Pilgrim et al. Biodegradable – versus durable-polymer drug-eluting stents for STEMI. Final 2-year outcomes of the BIOSTEMI trial. J Am Coll Cardiol. Cardiovasc Interven. 2021, doi: 10.1016/j.jcin.2020.12.011.
3 Vogel B et al. ST-segment elevation myocardial infarction; Nature Reviews Disease Primers. 2019; 5(1):39.
4 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.
5 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.
*Orsiro DES is not currently indicated for STEMI patients.
Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies.
Xience is a trademark or registered trademark of the Abbott Group of Companies.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.