Met with Resolute Onyx DES (17.1%) noninferior to BioFreedom DCS (16.9%) for cardiac death, myocardial infarction (MI), and stent thrombosis (ST)‡
Low event rates for Resolute Onyx DES in a highly complex HBR patient population, including significantly lower MI versus BioFreedom DCS.#
Onyx ONE Global Study Results
Published by The New England Journal of Medicine
The first study in the United States and Japan evaluating 1-month DAPT duration in HBR patients with a current DES.
“Clear” patients are defined as being event-free** and
DAPT-adherent for the first 30 days post-procedure.
The Onyx ONE Clear study showed 7.0% cardiac death or myocardial infarction at one year, beating the performance goal of 9.7%.1
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Matching LEADERS FREE inclusion criteria.
At 1 year.
Device success was not a powered endpoint or adjusted for multiplicity.
Crossover was not prespecified, powered, or adjusted for multiplicity.
From 1 month to 1 year.
Post-hoc analyses were not powered.
Patients must be free of spontaneous MI, repeat revascularisation, stroke, stent thrombosis, and death through 1 month.
ZEUS, LEADERS FREE, and SENIOR trials.
Kirtane A, et al. One Month Dual Antiplatelet Therapy in High Bleeding Risk Patients: Primary Results of Onyx ONE Clear. Presented online at ACC 2020.
Windecker S, Latib A, Kedhi E, et al. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. March 26, 2020;382(13):1208-1218.
Kedhi E, Latib A, Abizaid A, et al. Rationale and design of the Onyx ONE global randomized trial: A randomized controlled trial of high bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy. Am Heart J. August 2019;214:134-141.