Onyx ONE Header

ONYX ONE THE ONLY ONE

Resolute Onyx DES was shown to be safe and effective with superior acute performance in highly complex high bleeding risk (HBR) patients with 1-month DAPT.1
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STUDY DETAILS

~2,000 HBR patients  | Only DES vs. DES trial  |  1-month DAPT

One-Year Results

Resolute Onyx DES was safe and effective with 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

ST||

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

   

Onyx ONE Trial Design A
HBR Inclusion Criteria

1.6 HBR CRITERIA PER PATIENT

Used the broadest inclusion
criteria of high bleeding
risk patients.††2

46% of Patients

Met two or more HBR criteria3

HIGHLY COMPLEX RESOLUTE
ONYX DES
PATIENT POPULATION

53%

ACS
 

80%

B2/C LESIONS

39%

DIABETES

46%

MODERATE/SEVERE
CALCIFIED LESIONS

26%

PRIOR MI

33%

ATRIAL FIBRILLATION

Onyx ONE Physician Discussion

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*

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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

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

2

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.

3

Data on file at Medtronic.