Final 5-Year Data from BIOFLOW-V Trial Confirms Better Safety for Orsiro DES

BIOTRONIK Sets New Clinical Benchmark with Ultrathin Strut Orsiro Coronary Drug-Eluting Stent

February 28, 2022 — BIOTRONIK announced five-year data from the BIOFLOW-V trial, which was presented yesterday at the 2022 CRT Conference during a late-breaking-clinical-trial session by Dr. David Kandzari, US Principal Investigator, Piedmont Heart Institute, Atlanta, Georgia.

The five-year follow-up data demonstrates consistently lower clinical event rates in target lesion failure (TLF) and significantly lower rates of target-vessel myocardial infarction (TV-MI). These data reinforce the body of evidence differentiating Orsiro®DES from other contemporary DES – the first and only ultrathin strut DES proven to outperform Xience DES.^1,2,3 Orsiro DES received FDA approval in 2019 and has been used to treat more than three million patients worldwide to date. The latest generation of BIOTRONIK’s DES Orsiro® Mission gained FDA approval in 2021 and benefits from the same stent as its predecessor device with a reengineered delivery system for even better deliverability.*

"The final five-year follow up data confirms Orsiro’s superior safety profile and low TLF rates." said Dr. David Kandzari. "The ultrathin strut Orsiro stent significantly reduces the risk for TV-MI and shows a low rate of stent thrombosis (ST), and specifically a significant reduction in late and very late stent thrombosis. These long-term results confirm that the Orsiro DES sets a new clini-cal benchmark in PCI treatment options."

The clinical performance of the Orsiro DES in the pivotal BIOFLOW-V trial (n=1334)² has already demonstrated significantly lower rates for TLF and TV-MI compared to Xience DES at 12 months follow up and continued to show significant differences across the most important secondary endpoints at 36 months follow up.⁴

BIOFLOW-V is the first large randomized trial to show improved long-term outcomes in the field of DES over Xience DES. The international study included 1334 patients, of which a sizable percentage were complex: 50.8% of patients presented with acute coronary syndrome (ACS),⁶ 35.0% of patients were diabetic,⁶ and 73.8% of lesions were ACC/AHA Class B2/C.⁷

“The BIOFLOW-V long term study results continue to prove that Orsiro DES provides best clinical outcomes, complementing the proven superiority in STEMI demonstrated in the BIOSTEMI trial 8. Orsiro DES has one of the most extensive clinical programs of any contemporary DES including more than 68 clinical studies and over 55.000 enrolled patients to date,**” commented Alexander Uhl, President Vascular Intervention at BIOTRONIK, “and with the new Orsiro Mission DES now available, we have the same clinical performance with next level deliverability, making it a'must have' in every cath-lab."

*Clinical data conducted with Orsiro, Orsiro Mission’s predecessor device can be used to illustrate Orsiro Mission clinical data.

**BIOTRONIK data on file, status as per January 2020

Orsiro and Orsiro Mission are trademarks or registered trademarks of the BIOTRONIK Group of Companies.

References

1. Xience is a trademark or registered trademark of the Abbott Group of Companies.

2. Kandzari D et al. The Lancet. 2017, 390(10105).

3. Pilgrim et al. Biodegradable – versus durable-polymer drug-eluting stents for STEMI. Final 2-year outcomes of the BIOSTEMI trial. J Am Coll Cardiol. Cardiovasc Interven. 2021, doi: 10.1016/j.jcin.2020.12.011.

4. Kandzari D et al. J Am Coll Cardiol. Cardiovasc Interven. 2020, doi: 10.1016/j.jcin.2020.02.019.

5. Kandzari D presented at CRT 2022 – Late Breaking Clinical Trial February 27th, 2022, Late Breaking Trials: Session I

6. Kandzari et al, Supplement to: Kandzari DE, Mauri L, Koolen JJ et al. Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents in Patients Undergoing Coronary Revascularisation  (BIOFLOW V): a randomised trial, JACC, 2017

7. Kandzari, BIOFLOW V – Comparison of ultrathin sirolimus eluting bioresorbable polymer with thin everolimus eluting durable polymer stents, Presented at ESC Congress, Barcelona, 2017

8. Pilgrim et al. Biodegradable – versus durable-polymer drug-eluting stents for STEMI. Final 2-year outcomes of the BIOSTEMI trial. J Am Coll Cardiol. Cardiovasc Interven. 2021, doi: 10.1016/j.jcin.2020.12.011

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