Medtronic is committed to developing additional evidence to help guide dual antiplatelet therapy treatment decisions, which are best made on an individual basis and should integrate current guidelines, clinical judgement, assessment of the benefit/risk ratio, and patient preference. Resolute Onyx™ DES is not currently indicated for high bleeding risk patients on 1-month DAPT.
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**
“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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Current ACC/AHA guidelines regarding DAPT duration following PCI: Per ACC/AHA guidelines, a daily aspirin dose of 81 mg is recommended indefinitely after PCI. A P2Y12 platelet inhibitor should be given daily for at least 6 months in stable ischemic heart disease (SIHD) patients and for at least 12 months in patients with acute coronary syndrome (ACS). Consistent with the 2016 ACC/AHA guidelines, longer duration of DAPT may be considered in any patients at higher ischemic risk with lower bleeding risk. In patients at higher risk of bleeding, DAPT discontinuation may be reasonable after 3 months in stable SIHD patients or 6 months in ACS patients. Decisions about duration of DAPT are best made on an individual basis and should integrate clinical judgement, assessment of the benefit/risk ratio, and patient preference. Physicians should consider all of the available evidence on DAPT to make the most appropriate decisions for each of their patients. Resolute Onyx DES is not currently indicated for high bleeding risk patients on 1-month DAPT.
Matching LEADERS FREE inclusion criteria.
At 1 year.
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.