Based on results from the Onyx ONE Clear Analysis, evaluating over 1,500 complex HBR patients.
High bleeding risk (HBR) patients are a large, growing, complex population that historically had little evidence to support treatment decisions. For these reasons, Medtronic initiated the Onyx ONE Month DAPT Program.
Watch Dr. David Kandzari discuss the
Onyx ONE Month DAPT Program.
Watch an interview with Dr. David Kandzari as he discusses the Onyx ONE Month DAPT Program
First prospective, randomized,
1-month DAPT trial comparing a DES to a DES in ~2,000 HBR patients.
Resolute Onyx DES met the primary endpoint for cardiac death, myocardial infarction, and stent thrombosis, showing non-inferiority vs. BioFreedom™* DCS at 12 months (17.1% vs. 16.9%).2
Low event rates for Resolute Onyx DES in a highly complex HBR patient population, including significantly lower MI vs. BioFreedom DCS¶
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 analysis showed 7.0% cardiac death or myocardial infarction at one year, beating the performance goal of 9.7%.3
Performance goal derived from contemporary 1-month DAPT trials.**
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Matching LEADERS FREE inclusion criteria.
Device success was not a powered endpoint or adjusted for multiplicity.
Crossover and acute gain were not pre-specified, 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 revascularization, stroke, stent thrombosis, and death through 1 month.
ZEUS, LEADERS FREE, and SENIOR trials.
Kedhi E, Latib A, Abizaid A, et al. Rationale and design of the Onyx ONE global randomised trial: A randomised 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.
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.
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.
BioFreedom DCS is not approved for use in the United States.