1-Month DAPT Evidence In Complex Patients

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

Evaluating Resolute Onyx DES in ~1,700 patients with 1-month DAPT
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Medtronic is committed to developing additional evidence to help guide dual antiplatelet therapy treatment decisions, which are best made on an individual basis and should integrate current guidelines, clinical judgement, assessment of the benefit/risk ratio, and patient preference. Resolute Onyx™ DES is not currently indicated for high bleeding risk patients on 1-month DAPT. 

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 Population1

Onyx ONE Month DAPT Program table highlighting patient criteria details from the Onyx ONE Global Study and Onyx ONE Clear Study

Onyx ONE Month DAPT Program Resources

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

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

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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.

Current ACC/AHA guidelines regarding DAPT duration following PCI: Per ACC/AHA guidelines, a daily aspirin dose of 81 mg is recommended indefinitely after PCI. A P2Y12 platelet inhibitor should be given daily for at least 6 months in stable ischemic heart disease (SIHD) patients and for at least 12 months in patients with acute coronary syndrome (ACS). Consistent with the 2016 ACC/AHA guidelines, longer duration of DAPT may be considered in any patients at higher ischemic risk with lower bleeding risk. In patients at higher risk of bleeding, DAPT discontinuation may be reasonable after 3 months in stable SIHD patients or 6 months in ACS patients. Decisions about duration of DAPT are best made on an individual basis and should integrate clinical judgement, assessment of the benefit/risk ratio, and patient preference. Physicians should consider all of the available evidence on DAPT to make the most appropriate decisions for each of their patients. Resolute Onyx DES is not currently indicated for high bleeding risk patients on 1-month DAPT.

Matching LEADERS FREE inclusion criteria.

§

At 1 year.

||

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.

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.