New Data Presented at EuroPCR Confirms Orsiro’s Position as a Leading DES
BIO-RESORT One- to Two-Year Landmark Analysis Shows Significantly Lower TLF and TLR Rates for Orsiro Compared to Resolute Integrity with a Favorable Trend Compared to Synergy
Two-year outcome data from the BIO-RESORT randomized controlled trial were presented in a late-breaking clinical trials session by Dr. Marlies M. Kok, Thoraxcentrum Twente, MST, Enschede, the Netherlands and simultaneously published in EuroIntervention.
Results from this large scale three-arm trial with complex all-comers population treated with highly dissimilar contemporary drug-eluting stents (DES) confirmed the trend seen with the one-year data, supporting the use of ultrathin bioabsorbable polymer DES.
At the two-year follow-up in the BIO-RESORT trial (n=3,514), all three stents showed low target vessel failure (TVF) rates. Orsiro1 demonstrated a favorable trend without reaching statistical significance2 (Orsiro 6.6%, Synergy3 6.8%, Resolute Integrity4 8.3%).
The landmark analysis2, evaluating the incremental events between the first and second year of follow-up, showed patients in the Orsiro arm with significantly lower rates of target lesion failure (TLF) in comparison to the permanent-polymer DES arm (respectively Orsiro 1.1%, Resolute Integrity 2.4% p=0.02) and numerically lower than in the biodegradable-polymer DES Synergy arm (Synergy 1.6%, Resolute Integrity 2.4% p=0.22). Furthermore, the landmark analysis demonstrated that Orsiro achieved the lowest rate of TLR beyond one year across all arms (respectively Orsiro 0.6%, Resolute Integrity 1.5% p=0.04; Synergy 0.9%, Resolute Integrity 1.5% p=0.18).
The investigators noted that “very thin-strut biodegradable polymers DES have flexible designs and refined coatings to promote re-endothelialization and reduce the risk of ischemic coronary events” and also that “given those signals seen from the landmark analysis, the ultrathin 60 micron5 bioabsorbable polymer Orsiro DES might reduce the risk of repeat revascularization after the first year of follow-up.”
This data is in line with previously presented BIOFLOW-V6 results demonstrating significantly better outcomes for Orsiro compared to a permanent polymer DES (Xience7).
“The results reported in the BIO-RESORT reinforce those of BIOFLOW-V, showing ultrathin 60-micron bioabsorbable-polymer Orsiro outperforming contemporary permanent polymer DES in clinical performance,” stated Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “These results add to the growing body of evidence that indicate Orsiro can provide a real advantage in patient outcomes.”
1CAUTION – investigational device in the United States. Limited by US law to investigational use.
2Kok, M. on behalf of BIO-RESORT investigators, BIO-RESORT late breaking clinical trial, presented at EuroPCR 2018.
3Synergy is a registered trademark of Boston Scientific.
4Resolute and Resolute Integrity are registered trademarks of Medtronic.
5Ø 2.25 – 3.0 mm
6Kandzari D. et al. Lancet. 2017, 390(10097).
7Xience and Xience Prime are registered trademarks of Abbott Cardiovascular Systems.
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.