Resolute Onyx DES closeup on light blue background

Advancing 1-month DAPT Evidence

Onyx ONE Clear Study1
Evaluating Resolute Onyx™ DES in ~1,500 highly complex high bleeding risk (HBR) patients with 1-month DAPT,* including ~600 patients in the United States and Japan.
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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. 

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, multicenter, 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.

One-year Results

Graph representing Resolute Onyx DES beating the performance goal for cardiac death or myocardial infarction.

Primary Endpoint

Highly Complex High Bleeding Risk PAtients 

no vessel or lesion limitations

  • 79% B2/C lesions
  • 37 mm average stented length
  • 50% moderate to severe calcified lesions

real-world patient population

  • 74 average age
  • 39% diabetes
  • 36% prior revascularization

BROAD HBR INCLUSION CRITERIA§2

  • 1.6 HBR criteria per patient
  • 44% patients having two or more HBR criteria

Sign Up for Onyx ONE Month DAPT Program Updates

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*

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 one-month DAPT.

Events include spontaneous MI, repeat revascularization, stroke, stent thrombosis, and death through 1 month.

ZEUS, LEADERS FREE, and SENIOR trials.

§

Matching LEADERS FREE inclusion criteria.

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

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.