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Alert Indications, Safety, and Warnings
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RESOLUTE ONYX DES NOW CE MARKED FOR 1-MONTH DAPT IN HBR PATIENTS

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 ProgramME 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 (CD), 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 shown 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)

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Onyx ONE Global Study Results
Published by The New England Journal of Medicine 

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

Windecker S, et al.

737KB

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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

  • 752 US/Japan HBR patients from prospective, multicenter, single-arm trial
  • Pooled with similar "clear" Resolute Onyx DES patients from the Onyx ONE Global study
  • ~1,500 patients included in primary endpoint analysis

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)

128KB

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pdf Onyx ONE Clear Results Presentation (ACC.20) (.pdf)

Kirtane A, et al.

528KB

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WANT TO LEARN MORE?

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CE Mark
*

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.