Onyx ONE clinical evidence Resolute Onyx™ DES

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Onyx ONE Global Trial

  • First randomised, 1-month DAPT trial comparing a DES to a DES in HBR patients
  • Showed Resolute Onyx DES was safe and effective at one year1
  • Final two-year results confirmed safety and efficacy2
  • Based on the trial, Resolute Onyx was the first DES CE-indicated for 1-month DAPT in HBR patients

Onyx ONE Clear Analysis

  • Prospective, multicentre, single-arm analysis that evaluated Resolute Onyx DES in ~1500 HBR patients on 1-month DAPT
  • Reinforced safety and efficacy results from the Onyx ONE Global Trial3
  • Based on this analysis, Resolute Onyx was the first DES FDA-indicated for HBR patients and labeled for 1-month DAPT4

Real-world patient population

Seven statistics used to highlight the real-world population of the Onyx ONE global trial and the Onyx ONE clear analysis

Results

Onyx ONE Global Trial results

  • 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 results
Published by The New England Journal of Medicine

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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
Published by Circulation: Cardiovascular Interventions

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Short-DAPT trials comparison

See how Onyx ONE compares to XIENCE 28 and POEM trials when it comes to trial design and patient population.

Additional Resources

See exclusive features and benefits

Resolute Onyx DES is different by design.

See Key Differences

Optimised for complex PCI

Resolute Onyx DES design exclusives make it ideal for complex cases.

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Bifurcation education

View five techniques that highlight Resolute Onyx DES through endoscopic imaging captured inside an isolated and reanimated beating porcine heart.

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CE mark
*

Third-party brands are trademarks of their respective owners.

Resolute Onyx DES received CE mark approval for 1-month DAPT in HBR patients in 2020.

References

1

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.

2

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.

3

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.

4

Resolute Onyx DES IFU.