Onyx ONE Header

ONYX ONE GLOBAL STUDY

Evaluating highly complex high bleeding risk (HBR) patients with 1-month DAPT1 — DES vs. DES.2

STUDY DETAILS

~2,000 HBR patients  |  Resolute Onyx DES vs. BioFreedom™* DCS  |   1-month DAPT     

One-Year Results

Resolute Onyx DES met primary endpoint and showed superior acute performance in HBR patients with 1-month DAPT.

PRimary endpoint

Resolute Onyx DES non-inferior to BioFreedom DCS

Onyx ONE Primary Endpoint

Primary Endpoint

17.1%

Resolute Onyx DES

16.9%

BioFreedom DCS


TLR§

2.8%

Resolute Onyx DES

4.0%

BioFreedom DCS


STII

1.3%

Resolute Onyx DES

2.1%

BioFreedom DCS

Device Success

Superior Acute Performance

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

  

Landmark Analysis 1-12 Months

Landmark Analysis  After DAPT Discontinuation

Low event rates for Resolute Onyx DES in a highly complex HBR patient population, including significantly lower MI vs. BioFreedom DCS.**

Onyx ONE Landmark Analysis

MI

4.3%

Resolute Onyx DES

6.8%

BioFreedom DCS

p = 0.01

ST

0.9%

Resolute Onyx DES

0.9%

BioFreedom DCS

CD

3.5%

Resolute Onyx DES

2.7%

BioFreedom DCS

Trial Design and Patient Population

Trial Design

BioFreedom DCS is currently recommended by the ESC guidelines for HBR patients who may need 1 month of DAPT.3   

Onyx ONE Trial Design A
HBR Inclusion Criteria

1.6 HBR CRITERIA PER PATIENT

Used the broadest inclusion
criteria of high bleeding
risk patients.††4

46% of Patients

Met two or more HBR criteria5

HIGHLY COMPLEX Resolute
Onyx DES
PATIENT POPULATION

80%

B2/C LESIONS

39%

DIABETES

46%

MODERATE/SEVERE

CALCIFIED LESIONS

Onyx ONE Physician Discussion

ADVANCING DAPT EVIDENCE

The Onyx ONE Clear Study is a prospective, multicenter, single-arm trial evaluating Resolute Onyx DES in HBR patients with 1-month DAPT in the U.S. and Japan.

LEARN MORE
*

Third-party brands are trademarks of their respective owners.

Acute performance parameters were not powered or adjusted for multiplicity.

At 1 year.

§

ST and TLR were not separately powered endpoints.

||

Def/prob ST.

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

#

Crossover and acute gain were not pre-specified, powered, or adjusted for multiplicity.

**

Post-hoc analyses were not powered.

††

Matching LEADERS FREE inclusion criteria.

1

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 DES family should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.

2

Windecker, et al. Data presented at TCT 2019; San Francisco, CA.

3

Valgimigli M, Bueno H, Byrne RA, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. January 14, 2018;39(3):213-260.

4

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.

5

Data on file at Medtronic.

BioFreedom DCS is not approved for use in the U.S.