BIOTRONIK Debuts Orsiro on US Market at CRT 2019 With New Data From BIO-RESORT, Meta-Analysis and Health Economic Evaluation
BIO-RESORT RCT Three-Year Data Analysis Shows a Consistent Trend Towards Lower Target Vessel Failure Rates for Orsiro Compared to Resolute Integrity and Synergy
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 Orsiro®2.
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%).
Meta-Analysis Shows Significant Reduction in Risk of Myocardial Infarction for Orsiro compared to Xience
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).
Lower Medical Costs, Better Patient Outcomes
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.
Orsiro DES Now Commercially Available in the US
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.”
1. von Birgelen C, on behalf of BIO-RESORT investigators. 3-years BIO-RESORT: Results Of The 3-arm Randomized Study In Allcomers, Treated With Contemporary Biodegradable Or Durable Polymer-coated Drug-eluting Stents. Presented at: CRT, Mar 3, 2019; Washington DC, USA.
2. Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies.
3. Synergy is a trademark or registered trademark of Boston Scientific Group of Companies.
4. Resolute, Integrity and Resolute Integrity are trademarks or registered trademarks of the Medtronic Group of Companies.
5. Pilgrim T. Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stents Versus Thin Strut Durable Polymer Everolimus-eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: A Meta-Analysis of Individual Patient Data From Randomized Controlled Trials. Presented at: CRT, Mar 3, 2019; Washington DC, USA.
6. Xience is a trademark or registered trademark of the Abbott Group of Companies.
7. Kandzari et al. JACC. Sep 2018. DOI: 10.1016/j.jacc.2018.09.019.
8. All cost estimates were CPI-adjusted to 2018 USD, future cost discounted by 3%.
9. Mattke et al. Cardiovascular Revascularization Medicine. Nov 2018. DOI: 10.1016/j.carrev.2018.11.006.
10. Mattke S. Health Economic Evaluation of the Two-Year Results After Implantation of an Ultrathin, Bioresorbable Polymer Sirolimus-Eluting Coronary Stent Compared to a Thin, Durable Polymer Everolimus-Eluting Stent. Presented at: CRT, Mar 4, 2019; Washington DC, USA.
11. Orsiro is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of ≤ 36 mm.
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.