BIOTRONIK Debuts Orsiro on US Market at CRT 2019 With New Data From BIO-RESORT, Meta-Analysis and Health Economic Evaluation

Washington, D.C. and BUELACH, Switzerland, March 6, 2019 – Three-year outcome data from the BIO-RESORT¹ randomized controlled trial were presented in a late-breaking clinical trials session by Dr. Clemens von Birgelen, Thoraxcentrum Twente, MST, Enschede, The Netherlands. Results from this large three-arm trial with complex all-comers population treated with three highly dissimilar drug-eluting stents (DES) confirmed the trend of earlier data, supporting the use of the ultrathin bioabsorbable polymer DES Orsiro².

At the three-year follow-up in the BIO-RESORT trial, with a cohort of 3,514 patients, all three stents showed low target vessel failure (TVF) rates. Orsiro demonstrated favorable outcomes without reaching statistical significance (Orsiro 8.5%, Synergy³ 8.8%, Resolute Integrity⁴ 10.0%). The same tendency was observed for target lesion revascularization (TLR) where Orsiro demonstrated numerically lower values in comparison to Resolute Integrity and Synergy DES (Orsiro 2.9%, Synergy 3.3%, Resolute Integrity 3.8%).

Dr. Thomas Pilgrim, University of Bern, Switzerland, presented the results of a patient-level meta-analysis⁵ from four randomized controlled trials comparing the safety and efficacy of Orsiro to Xience⁶. From the pool of 4,480 patients from BIOFLOW-II, -IV, and -V, as well as BIOSCIENCE, 2,630 patients were treated with Orsiro and 1,850 with Xience. The primary endpoint was TLF at maximum duration of follow-up.

For the primary endpoint, Orsiro demonstrated a favorable trend without reaching statistical significance in comparison to Xience (11.9% vs. 14.5% respectively). No differences between Orsiro and Xience were seen in the individual components of TLF: Cardiac death occurred in 3.5% vs. 4.5% of the patients, target-vessel myocardial infarction in 5.0% vs. 6.5% and clinically-driven TLR in 5.9% vs. 7.0% for Orsiro and Xience, respectively. While the safety endpoint of definite or probable stent thrombosis did not show a statistical difference between Orsiro and Xience, (2.7% vs. 4.5% respectively), a statistically significant reduction in the risk of any myocardial infarction among patients undergoing PCI with Orsiro in comparison to Xience was observed (7.1% vs. 9.6%, p=0.03).

Dr. Soeren Mattke, University of Southern California, Los Angeles, California, presented results from the health economic evaluation based on the two-year results of the BIOFLOW-V clinical trial⁷. The evaluation used a Markov simulation to project the mortality and cost outcomes from a US health systems perspective⁸ over a horizon of four years and builds on work published in 2018⁹. The findings suggest that the use of the Orsiro stent is associated with a meaningful reduction in direct medical costs and improved patient outcomes compared to the Xience stent. The study estimated cost savings of $2,429 USD per patient over four years, assuming the two stents were priced at parity. Around two-thirds of the savings were due to the lower rate of spontaneous target vessel myocardial infarction in the first two years after stent implantation¹⁰.

The lower rate of adverse events for the Orsiro stent in the BIOFLOW-V trial is projected to reduce mortality risk by 6% over four years after stent implantation compared to the Xience stent¹⁰. “Those results may help clinicians, payers and purchasers to make decisions about the choice of coronary stents, as they suggest that the use of the Orsiro stent can simultaneously reduce medical costs and improve patient outcomes. For a high volume procedure like coronary stenting, these differences have meaningful implications for population health and financial sustainability of healthcare systems,” said Dr. Mattke.

On February 22, 2019 the FDA approved the Orsiro DES for the treatment of coronary artery disease. The ultrathin strut stent is now available for hospitals in the US, which means that interventionalists can rely on Orsiro’s deliverability to treat complex lesions¹¹ and challenging subgroups.

“The range and impact of Orsiro data presented at CRT 2019 demonstrate the contribution BIOTRONIK can make to the interventional landscape in the US,” stated Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “With the FDA approval of Orsiro we are not only bringing technical innovation, but one of the most exciting clinical research programs in the industry to the US interventional community.”

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.

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