1-month DAPT data in complex, high bleeding risk patients
The Onyx ONE Month DAPT Program
The Onyx ONE Month DAPT program consists of the Onyx ONE Global Trial and the Onyx ONE Clear Analysis:
Onyx ONE Global Trial
First prospective randomized, 1-month DAPT trial comparing a DES to a DES in HBR patients
Showed Resolute Onyx™ DES was safe and effective at 1 year1
Final two-year results confirmed safety and efficacy2
Based on the trial, Resolute Onyx™ was the first DES to receive a CE indication for 1-month DAPT in high bleeding risk patients.
Onyx ONE Clear Analysis
Evaluated Resolute Onyx™ DES in ~ 1500 HBR patients on 1-month DAPT
Reinforced safety and efficacy results from Onyx ONE Global Trial3
Based on this analysis, Resolute Onyx™ was the first DES to receive FDA approval for high bleeding risk patients with 1-month DAPT labeling.4
Complex HBR patient population in the Onyx ONE Month DAPT program
No vessel or lesion limitations
Real-world patient population
B2/C lesions
Average stented length
Moderate/severe calcified lesions
ACS patients included
AF patients included
Diabetic patients included
Prior revasc.
Onyx ONE Global Trial
Resolute Onyx™ DES Arm patients studied
1003
80%
38mm
46%
53%
33%
39%
31%
Onyx ONE Clear Analysis
"Clear" patients treated with Resolute Onyx™ DES
1506
79%
37mm
50%
49%
36%
39%
36%
Onyx ONE Global Trial results
First prospective, randomized, 1-month DAPT trial comparing a DES to a DES in ~2,000 HBR patients.
At one year: primary endpoint met with Resolute Onyx™ DES (17.1%) noninferior to BioFreedom™* DCS (16.9%) for cardiac death (CD), myocardial infarction (MI), and stent thrombosis (ST)1
Final two-year follow-up: Safety and efficacy maintained with Resolute Onyx™ DES (21.3%) noninferior to BioFreedom DCS (20.7%)2
The first study in the United States and Japan evaluating 1-month DAPT duration in HBR patients with a current DES.
Onyx ONE Clear Analysis results
Evaluated 752 HBR patients in the U.S. and Japan from the single-arm analysis, pooled with similar Resolute Onyx™ DES patients from the Onyx ONE Global Trial who were clear of events after 1-month DAPT.
Resulted in an analysis of ~1500 HBR patients on 1-month DAPT
Primary endpoint results: 7.0% cardiac death or myocardial infarction at one year, beating the performance goal of 9.7%3
Resolute Onyx™ DES is safe and effective in real-world HBR patients on 1‑month DAPT
Based on results from the Onyx ONE Clear Analysis, evaluating over 1,500 complex HBR patients.
DAPT duration decisions are best made on an individual basis. Premature discontinuation or interruption of prescribed antiplatelet medication could result in a higher risk of ST, MI, or death.
TM* Third-party brands are trademarks of their respective owners.
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.
Windecker S, et al. Final Two-Year Results from the Randomized Onyx ONE Trial in High Bleeding Risk Patients Treated with 1-month DAPT. Presented at ACC 2021.
Kandzari DE, Kirtane AJ, Windecker S, et al. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. November 2020;13(11):e009565.
