Resolute Onyx Drug-eluting Stent Onyx One Clinical Evidence

Safe and effective in real-world, high bleeding risk (HBR) patients on
1-month DAPT.

Alert Indications, Safety, and Warnings
Blue box reading "1-month DAPT"

Resolute Onyx™ DES Is Indicated for HBR Patients on
1-month DAPT

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

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. 

Onyx ONE Month DAPT Program

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

Table comparing patient criteria in the Onyx ONE Global Study and the Onyx ONE Clear Analysis
Enlarge

   

Onyx One Global Trial

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 Trial Resources

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

427KB

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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

  • 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 Trial
  • ~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

Onyx ONE Clear Study Resources

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

459KB

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pdf ACC 2020 Onyx ONE Clear Study Presentation (.pdf)

759KB

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*

Third-party brands are trademarks of their respective owners.

†

Matching LEADERS FREE inclusion criteria.

‡

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

§

Crossover and acute gain were not prespecified, powered, or adjusted for multiplicity.

||

From one month to one year.

Post-hoc analyses were not powered.

#

Patients must be free of spontaneous MI, repeat revascularization, stroke, stent thrombosis, and death through one 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

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.

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