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ADVANCING DAPT EVIDENCE

High bleeding risk (HBR) patients are a large, growing, complex population that historically had little evidence to support treatment decisions. For these reasons, Medtronic initiated the Onyx ONE Month DAPT Program. 

Animation showing that Onyx ONE Global Study plus the Onyx ONE Clear Study equals the Onyx ONE Month DAPT Program

Onyx ONE Month DAPT Program Enrolled a Highly Complex HBR Patient Population 

Table illustrating details of patients enrolled in the Onyx ONE Month DAPT Program

Onyx one global study

First prospective, randomised, 1-month DAPT trial comparing a DES to a DES in ~2,000 HBR patients.

Primary Endpoint

Met with Resolute Onyx DES (17.1%) noninferior to BioFreedom DCS (16.9%) for cardiac death, myocardial infarction (MI), and stent thrombosis (ST)‡

Acute Performance 

  • Superior device success§
  • Significantly higher crossover from BioFreedom DCS to Resolute Onyx DES||

Landmark Analysis
1–12 Months after DAPT Discontinuation¶2

Low event rates for Resolute Onyx DES in a highly complex HBR patient population, including significantly lower MI versus BioFreedom DCS.#

Landmark analysis chart from the Onyx ONE Global Study showing 1–12 months after DAPT discontinuation

ADDITIONAL RESOURCES

pdf Onyx ONE Global Study Brochure (.pdf) (opens new window)

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pdf Onyx ONE Global Study Results Presentation (TCT 2019) (.pdf) (opens new window)

Windecker S, et al.

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Onyx ONE Global Study Results(opens new window)
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.

Study Details

  • Prospective, multicentre, single-arm trial
  • 601 HBR patients pooled with similar “clear” Resolute Onyx DES patients from the Onyx ONE Global Study
  • ~1,500 patients included in primary endpoint analysis

“Clear” patients are defined as being event-free** and
DAPT-adherent for the first 30 days post-procedure.

Primary Endpoint Results

The Onyx ONE Clear study showed 7.0% cardiac death or myocardial infarction at one year, beating the performance goal of 9.7%.1

Graph showing performance goal beat derived from contemporary 1-month DAPT trials

ADDITIONAL RESOURCES

pdf Onyx ONE Clear One-page Summary (.pdf) (opens new window)

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pdf Onyx ONE Clear Results Presentation (ACC.20) (.pdf) (opens new window)

Kirtane A, et al.

528KB

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Onyx ONE Physician Discussion

WANT TO LEARN MORE ABOUT THE ONYX ONE MONTH DAPT PROGRAM

KEEP ME INFORMED (opens new window)
*

Third-party brands are trademarks of their respective owners.

†

Matching LEADERS FREE inclusion criteria.

‡

At 1 year.

§

Device success was not a powered endpoint or adjusted for multiplicity.

||

Crossover was not prespecified, powered, or adjusted for multiplicity.

From 1 month to 1 year.

#

Post-hoc analyses were not powered.

**

Patients must be free of spontaneous MI, repeat revascularisation, stroke, stent thrombosis, and death through 1 month.

††

ZEUS, LEADERS FREE, and SENIOR trials.

References

1

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.

2

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.

3

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.