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The Only DES Proven Safe and Effective With 1-month DAPT in HBR Patients

Resolute OnyxTM Drug-Eluting Stent
Alert Indications, Safety, and Warnings
Blue box reading 1-month DAPT

Resolute Onyx is the only DES indicated for high bleeding risk (HBR) patients & labeled for 1-month DAPT.

Based on results from the Onyx ONE Clear Analysis, evaluating over 1,500 complex 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. 

Watch Dr. David Kandzari discuss the
Onyx ONE Month DAPT Program.

Onyx ONE Month DAPT Program Enrolled a Highly Complex HBR Patient Population1

Onyx ONE Global Study and Onyx ONE Clear Analysis criteria and patient population.

Onyx ONE Month DAPT Program Resources

pdf Resolute Onyx HBR Indication Brochure (.pdf)

468KB

Download the Resolute Onyx HBR Indication brochure to view results from the Onyx ONE Month DAPT Program, including Onyx ONE Global Study and Onyx ONE Clear Study.

   

Onyx one global study

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

Primary Endpoint

Resolute Onyx DES met the primary endpoint for cardiac death, myocardial infarction, and stent thrombosis, showing non-inferiority vs. BioFreedom™* DCS at 12 months (17.1% vs. 16.9%).2

Acute Performance 

  • Superior device success‡
  • Significantly higher crossover from BioFreedom DCS to Resolute Onyx DES§
  • Significantly higher acute gain§

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 vs. BioFreedom DCS

Landmark Analysis graph depicting low event rates for Resolute Onyx DES in a highly complex HBR patient population

Onyx ONE Global Study Resources

pdf Onyx ONE Global Study One-page Summary (.pdf)

427KB

Download the Onyx ONE Global Study one-page summary

Onyx ONE Global Study 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

  • 752 HBR patients from the United States and Japan in a prospective, multicenter, single-arm trial
  • Pooled with similar “clear” Resolute Onyx DES patients from the Onyx ONE Global Study
  • ~1,500 total 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 analysis showed 7.0% cardiac death or myocardial infarction at one year, beating the performance goal of 9.7%.3

Performance goal derived from contemporary 1-month DAPT trials.**

Chart showing how Resolute Onyx DES beat the performance goal for cardiac death and myocardial infarction (MI).

Onyx ONE Clear Study Resources

pdf Onyx ONE Clear Study One-pager (.pdf)

459KB

Download the Onyx ONE Clear Study one-pager
pdf ACC 2020 Onyx ONE Clear Study Presentation (.pdf)

759KB

ACC 2020 Onyx ONE Clear Study Presentation Intro Slide
Image showing group of physicians talking

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*

Medtronic and Medtronic logo are trademarks of Medtronic.  Third-party trademarks ("™*") belong to their respective owners.  All other brands are trademarks of a Medtronic entity.

†

Matching LEADERS FREE inclusion criteria.

‡

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

§

Crossover and acute gain were not pre-specified, 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 revascularization, stroke, stent thrombosis, and death through 1 month.

**

ZEUS, LEADERS FREE, and SENIOR trials.

References

1

Kedhi E, Latib A, Abizaid A, et al. Rationale and design of the Onyx ONE global randomised trial: A randomised 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.

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

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.

BioFreedom DCS is not approved for use in the United States.