Orsiro Drug-Eluting Stent Demonstrates Superiority in STEMI Patients
About 30 percent of patients undergoing primary percutaneous coronary intervention (PCI) suffer from ST-Elevation Myocardial Infarction (STEMI) – the most acute form of coronary artery disease. It’s caused by a complete thrombotic occlusion and is associated with significant morbidity and mortality.1
With Orsiro, we can incrementally improve patients’ care path.
Following his presentation at a Late-Breaking session of the European Society of Cardiology (ESC) Congress, Dr. Juan F. Iglesias of Geneva University Hospitals has communicated the benefits of BIOTRONIK’s Orsiro drug-eluting stent (DES) for the challenging STEMI patient group.* Dr. Iglesias is a co-principal investigator of the BIOSTEMI clinical trial, which found using Orsiro to be associated with a 41 percent lower risk of target lesion failure (TLF) at 12 months, when compared to Abbott’s Xience. The study enrolled 1,300 patients and has since been published in The Lancet.2
Although STEMI patients make up a third of primary PCI cases, BIOSTEMI is the first randomized clinical trial, powered for superiority, to look at them specifically. “BIOSTEMI is not only the first randomized clinical trial comparing two contemporary drug-eluting stents, it is also the first randomized clinical trial comparing two new devices with high standing platforms in patients with STEMI,” says Dr. Iglesias, adding that he hopes the trial will lead to further research gaps being closed. “The use of these stents is mainly supported by non-inferiority trials, including all-comer patients, and for the first time we have a sub-group of patients that’s been shown to benefit from a dedicated stent.”
The ultrathin Orsiro was launched in the CE market in 2011 and received FDA approval in 2019. Orsiro’s safety, efficacy and clinical performance has been investigated in an extensive clinical program with more than 48,5003 patients enrolled so far.
“Based on the data, compared to the Xience stent, Orsiro is a superior solution for STEMI patients. In this patient group, vascular healing is a challenge due to the complex environment with the vessel. With Orsiro, we can incrementally improve patients’ care path”, concluded Dr. Iglesias.
* For indications, please see Instructions for Use
1 Vogel B et al. ST-segment elevation myocardial infarction; Nature Reviews Disease Primers. 2019; 5(1):39.
2 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, randomised superiority trial. The Lancet. Published online: Sep 2, 2019. DOI: https://doi.org/10.1016/S0140-6736(19)31877-X
3 Status January 2019