10.05.15
A drug-eluting stent developed by Biotronik SE & Co. Kg is comparable to Terumo's Nobori stent and can help significantly reduce thrombosis risk, clinical trial results indicate.
One year results from Biotronik's SORT OUT VII trial confirmed Orsiro's efficacy compared with the bioabsorbable polymer biolimus-eluting Nobori stent in an all-comers population. In addition, patients in the Orsiro arm had a significantly lower rate of definite stent thrombosis, a potentially dangerous adverse event following coronary intervention. Only 0.4 percent of Orsiro patients experienced thrombosis compared with 1.2 percent of patients in the Nobori arm (p=0.03).
SORT OUT VII compares the ultra-thin strut sirolimus-eluting Orsiro to the biolimus-eluting Nobori drug-eluting stent in coronary artery lesion disease treatment. During the trial, 1,261 patients underwent treatment with Orsiro, while 1,264 patients were treated with Nobori. At one year, the primary endpoint target lesion failure, defined as a composite of cardiac death, myocardial infarction or target lesion revascularization within one year, occurred in 3.8 percent of Orsiro patients vs. 4.6 percent of those treated with Nobori DES (p-value for non-inferiority < 0.0001).
Experts contend that Orsiro's 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 following percutaneous coronary intervention.
"Several factors, including significantly thinner struts and more controlled drug release, distinguish Orsiro from other bioabsorbable polymer DES," said Lisette Okkels Jensen, M.D., a physician at Odense University Hospital in Denmark who also is the SORT OUT VII principal investigator. "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."
Launched in 2011, the Orsiro Hybrid drug-eluting stent (DES) features a hybrid solution that combines passive and active components. proBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue, according to the company. The stent's BIOlute active coating contains a highly biocompatible polymer that delivers a limus drug through a bioabsorbable matrix. This hybrid coating is layered on top of the PRO-Kinetic energy stent platform, renowned for its advanced ultra-thin strut stent design and deliverability.
"These results reconfirm those of Bioscience, the largest independent comparison between Orsiro and Xience Prime to date. Bioscience confirmed Orsiro's performance as best-in-class and its results were published in the Lancet," said Daniel Buehler, Ph.D., president of Vascular Intervention at Biotronik. "Now Orsiro has proven itself in an even larger, real-world patient population, demonstrating efficacy and safety. We are certain that Orsiro's ultra-thin strut design and drug deliverability will continue to impress."
Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.
One year results from Biotronik's SORT OUT VII trial confirmed Orsiro's efficacy compared with the bioabsorbable polymer biolimus-eluting Nobori stent in an all-comers population. In addition, patients in the Orsiro arm had a significantly lower rate of definite stent thrombosis, a potentially dangerous adverse event following coronary intervention. Only 0.4 percent of Orsiro patients experienced thrombosis compared with 1.2 percent of patients in the Nobori arm (p=0.03).
SORT OUT VII compares the ultra-thin strut sirolimus-eluting Orsiro to the biolimus-eluting Nobori drug-eluting stent in coronary artery lesion disease treatment. During the trial, 1,261 patients underwent treatment with Orsiro, while 1,264 patients were treated with Nobori. At one year, the primary endpoint target lesion failure, defined as a composite of cardiac death, myocardial infarction or target lesion revascularization within one year, occurred in 3.8 percent of Orsiro patients vs. 4.6 percent of those treated with Nobori DES (p-value for non-inferiority < 0.0001).
Experts contend that Orsiro's 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 following percutaneous coronary intervention.
"Several factors, including significantly thinner struts and more controlled drug release, distinguish Orsiro from other bioabsorbable polymer DES," said Lisette Okkels Jensen, M.D., a physician at Odense University Hospital in Denmark who also is the SORT OUT VII principal investigator. "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."
Launched in 2011, the Orsiro Hybrid drug-eluting stent (DES) features a hybrid solution that combines passive and active components. proBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue, according to the company. The stent's BIOlute active coating contains a highly biocompatible polymer that delivers a limus drug through a bioabsorbable matrix. This hybrid coating is layered on top of the PRO-Kinetic energy stent platform, renowned for its advanced ultra-thin strut stent design and deliverability.
"These results reconfirm those of Bioscience, the largest independent comparison between Orsiro and Xience Prime to date. Bioscience confirmed Orsiro's performance as best-in-class and its results were published in the Lancet," said Daniel Buehler, Ph.D., president of Vascular Intervention at Biotronik. "Now Orsiro has proven itself in an even larger, real-world patient population, demonstrating efficacy and safety. We are certain that Orsiro's ultra-thin strut design and drug deliverability will continue to impress."
Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.