March 10, 2019
Biotronik Launches Orsiro DES With Presentations of Data at CRT
March 6, 2019—Biotronik announced that 3-year outcomes from the BIO-RESORT randomized controlled trial were presented by Clemens von Birgelen, MD, as late-breaking clinical data at CRT 2019, the Cardiovascular Research Technologies annual meeting held March 2–5 in Washington, DC.
According to the company, 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 company's ultrathin bioabsorbable polymer Orsiro DES. The FDA approved the Orsiro DES for the treatment of coronary artery disease on February 22.
The 3-year follow-up in the BIO-RESORT trial, which included a cohort of 3,514 patients, showed that all three stents showed low target vessel failure rates. Orsiro demonstrated favorable outcomes without reaching statistical significance (Orsiro, 8.5%; Synergy [Boston Scientific Corporation], 8.8%; Resolute Integrity [Medtronic], 10%). Additionally, Orsiro demonstrated numerically lower target lesion revascularization (TLR) values (Orsiro 2.9%, Synergy 3.3%, Resolute Integrity 3.8%).
Also at CRT, Biotronik noted that Thomas Pilgrim, MD, presented the results of a patient-level meta-analysis from the pool of 4,480 patients treated in four randomized controlled trials comparing the safety and efficacy of Orsiro (n = 2,630) to Xience (n = 1,850): BIOFLOW-II, -IV, and -V, as well as BIOSCIENCE.
For the primary endpoint of target lesion failure (TLF) at the maximum duration of follow-up, 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 (3.5% vs 4.5%), target-vessel myocardial infarction (5.0% vs 6.5%), and clinically driven TLR (5.9% vs 7.0%) for Orsiro and Xience, respectively.
In the safety endpoint of definite or probable stent thrombosis, there was no statistical difference between Orsiro and Xience (2.7% vs 4.5%). However, there was a statistically significant reduction in the risk of any myocardial infarction among patients undergoing percutaneous coronary interventions with Orsiro compared with Xience (7.1% vs 9.6%; P = .03).
Finally at CRT, results from the health economic evaluation based on the 2-year results of the BIOFLOW-V clinical trial were presented by Soeren Mattke, MD. The evaluation used a Markov simulation to project the mortality and cost outcomes from a perspective of health systems in the United States during 4 years and builds on work published in 2018.
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 with the Xience stent, stated Biotronik.
The study estimated cost savings of $2,429 per patient over 4 years, assuming the two stents were priced at parity. Approximately two-thirds of the savings were attributed to the lower rate of spontaneous target-vessel myocardial infarction in the first 2 years after stent implantation. The lower rate of adverse events for the Orsiro stent in the BIOFLOW-V trial is projected to reduce mortality risk by 6% over 4 years after stent implantation compared with the Xience stent.
In the company's announcement, Dr. Mattke commented, “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 health care systems.”