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.
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.
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 one-month DAPT.
Events include spontaneous MI, repeat revascularization, stroke, stent thrombosis, and death through 1 month.
ZEUS, LEADERS FREE, and SENIOR trials.
Matching LEADERS FREE inclusion criteria.
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.
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.