1-Year Data From SORT OUT VII Demonstrate Orsiro Noninferiority

May 26, 2015—Biotronik announced that new data regarding the Orsiro hybrid drug-eluting stent (DES) were presented during a Hot Line session at the EuroPCR 2015 conference in Paris, France. One-year results from the SORT OUT VII trial confirmed Orsiro’s noninferiority to the bioabsorbable polymer biolimus-eluting Nobori stent (Terumo Interventional Systems) in an all-comers population. Patients in the Orsiro arm had a significantly lower rate of definite stent thrombosis (0.4% of Orsiro patients compared with 1.2% of patients in the Nobori arm; P = .03).

SORT OUT VII is an investigator-initiated, randomized, multicenter, two-arm, noninferiority study comparing the ultra-thin strut, sirolimus-eluting Orsiro DES to the biolimus-eluting Nobori DES in the treatment of coronary artery lesions. During the trial, 1,261 patients underwent treatment with Orsiro, whereas 1,264 patients were treated with Nobori. At 1 year, the primary endpoint target lesion failure (TLF), defined as a composite of cardiac death, myocardial infarction, or target lesion revascularization within 1 year, occurred in 3.8% of Orsiro patients versus 4.6% of those treated with the Nobori DES (P for non-inferiority < .0001).

During the Hot Line session at EuroPCR, physicians discussed potential explanations for Orsiro’s enhanced safety profile and low rate of stent thrombosis, citing that Orsiro’s unique ultra-thin strut stent design enables greater flexibility than thicker strut designs, and may lead to improved apposition to the vessel wall and quicker endothelialization after percutaneous coronary intervention.

“Several factors, including significantly thinner struts and more controlled drug release, distinguish Orsiro from other bioabsorbable polymer DES,” commented Dr. Jensen. “These refinements could explain the trend towards lower rates of adverse events for Orsiro, exemplified by the considerably reduced risk of definite stent thrombosis seen in SORT OUT VII.”

According to the company, the Orsiro Hybrid DES, launched in 2011, features the latest development in Biotronik stent technology—a unique hybrid solution that combines passive and active components. The proBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue, and the BIOlute active coating contains a highly biocompatible polymer that delivers a limus drug via a bioabsorbable matrix. This hybrid coating is layered on top of the high-performance PRO-Kinetic Energy stent platform, which has an advanced ultra-thin strut stent design and outstanding deliverability.