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. This indication also applies to Onyx Frontier™ DES, which has the same stent platform as Resolute Onyx™ DES.

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. This indication also applies to Onyx Frontier™ DES, which has the same stent platform as Resolute Onyx™ DES.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

Mod./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

Onyx ONE Global Trial resources

Onyx ONE Global Trial results
Published by The New England Journal of Medicine 

Onyx ONE Clear Study

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 

 

 

Onyx Frontier™ 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 with Resolute Onyx™ DES.†

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. 

 

 

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