March 7, 2016 — Biotronik announced publication of results from the BIOSCIENCE trial in the journal EuroIntervention. The study’s authors suggest the Orsiro hybrid drug-eluting stent (DES) may have an advantage over Xience Prime/Xpedition in treating ST-segment elevation myocardial infarction (STEMI) patients. STEMI is a potentially fatal type of heart attack caused by a prolonged obstruction of blood supply in the heart. Every year nearly 250,000 people experience STEMI heart attacks.
A subanalysis of 407 STEMI patients included in the BIOSCIENCE trial revealed that Orsiro might be associated with better clinical outcomes than Xience Prime/Xpedition for this indication. At one year, BIOSCIENCE’s primary endpoint of target lesion failure (TLF) occurred in seven (3.3 percent) STEMI patients treated with Orsiro compared with 17 (8.7 percent) patients treated with Xience Prime/Xpedition.
BIOSCIENCE is the largest investigator-initiated study to date evaluating the safety and efficacy of Orsiro, a bioabsorbable polymer DES, in comparison to the durable polymer Xience Prime/Xpedition DES. Results from the multi-center, randomized, controlled non-inferiority trial were first published in The Lancet.
“During the BIOSCIENCE trial, Orsiro was associated with a significantly reduced risk of the primary endpoint of TLF for STEMI patients,” commented lead author Thomas Pilgrim, M.D., University Clinic for Cardiology, Bern, Switzerland. “We hypothesize this is due to Orsiro’s bioabsorbable polymer, which might provide favorable results on arterial healing after implantation. The effect of an enhanced healing response may be more pronounced in the inflammatory milieu of STEMI. As we currently have only limited data available on the clinical performance of newer generation DES in STEMI patients, we will soon attempt to extend these results in a dedicated randomized trial known as BIOSTEMI.”
The Orsiro Hybrid DES, launched in 2011, combines passive and active components. proBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue. BIOlute active coating contains a highly biocompatible polymer that delivers a limus drug via a bioabsorbable matrix. This hybrid coating system is layered on top of the high performance PRO-Kinetic Energy stent platform.
Read the February 2019 article FDA Clears Biotronik Orsiro Stent That Outperforms Xience
For more information: www.biotronik.com