BIOTRONIK today 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 clinical benchmark in PCI treatment options.”

The clinical performance of the Orsiro DES in the pivotal BIOFLOW-V trial (n=1,334)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 1,334 patients, of which a sizable percentage were complex: 50.8%⁶ of patients presented with acute coronary syndrome (ACS), 35.0%⁶ of patients were diabetic, and 73.8%⁷ of lesions were ACC/AHA Class B2/C.

“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."

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*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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