Clinical evidence
Resolute Onyx™ drug-eluting stent
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:
- 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.
- 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% |
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
Onyx ONE Global Trial resources
Onyx ONE Global Trial 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.
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
Onyx ONE Clear Analysis resources
Onyx ONE Clear results
Published by Cardiovascular Revascularization Medicine
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.