Clinical evidence Medtronic drug-eluting stents

Patients and lesions can be complex, increasing the burden on your practice. Medtronic is committed to advancing clinical data to provide the insights you may need for your patients. Even better, clinical data evaluating Resolute Onyx™ DES also applies to Onyx Frontier™ DES.

1-month DAPT in HBR patients

Resolute Onyx™ DES was shown to be safe and effective in complex, real-world, high bleeding risk (HBR) patients.1,2

Onyx ONE Global Trial

 

  • First randomised, 1-month DAPT trial comparing a DES to a DES in HBR patients.
  • Showed Resolute Onyx™ DES was safe and effective at one year.1
  • Final two-year results confirmed safety and efficacy.2
  • Based on the trial, Resolute Onyx™ was the first DES CE-indicated for 1-month DAPT in HBR patients.

Onyx ONE Global Trial results
Published by The New England Journal of Medicine

Onyx ONE Clear Analysis

 

  • Prospective, multicentre, single-arm analysis that evaluated Resolute Onyx™ DES in ~1,500 HBR patients on 1-month DAPT.
  • Reinforced safety and efficacy results from the Onyx ONE Global Trial.3
  • Based on this analysis, Resolute Onyx™ was the first DES FDA-indicated for HBR patients and labeled for 1-month DAPT.4

Onyx ONE Clear Analysis
Published by Circulation: Cardiovascular Interventions

Complex patient population

Onyx ONE Global Trial

  • 1,003 Resolute Onyx™ DES patients studied
  • 53% ACS patients included
  • 33% AF patients included
  • 39% diabetic patients included
  • 80% B2/C lesions
  • 38 mm average stented length
  • 46% moderate/severe calcified lesions

Onyx ONE Clear Analysis

  • 1,506 Resolute Onyx™ DES patients studied
  • 49% ACS patients included
  • 36% AF patients included
  • 39% diabetic patients included
  • 79% B2/C lesions
  • 37 mm average stented length
  • 50% moderate/severe calcified lesions
CE mark 2797

Left main PCI

The Medtronic DES extra-large platform was specifically designed to treat larger coronary vessel sizes, and their ability to expand to 6.0 mm makes them ideal for clinical research.

ROLEX Registry

Largest prospective study on left main (LM) PCI with a DES that has a dedicated extra-large stent platform (N = 450)

Low 5.1% TLF, 2.0% TLR, and 1.1% ST at one year5

Bar chart showing the event rates at one year from the ROLEX registry.

Resolute Onyx™ DES was safe and effective in complex, left main PCI with 99% device success.5

Complex patient population

  • 59% multivessel disease
  • 53% acute coronary syndrome
  • 30% diabetic

EBC MAIN

First randomised trial based on European Bifurcation Club (EBC) consensus, comparing a provisional to a planned, dual-stent strategy, LM bifurcation PCI (N = 467)

Resolute Onyx™ DES demonstrated excellent outcomes at one year6

Bar chart showing the event rates at one year from the EBC Main trial
Resolute Onyx™ is the only DES with randomised data supporting provisional and dual-stent strategies in LM bifurcation PCI.6
 
  • Primary endpoint (death, MI, TLR) showed numerically fewer serious adverse events in the provisional arm (14.7%) versus the dual-stent arm (17.7%).
  • Provisional arm showed significantly shorter procedure duration and fluoroscopy time.

Small-vessel

The Medtronic DES small-vessel platform starts at 2.00 mm, and its exceptional deliverability helps reach distal, highly occluded, small vessels.7  

DISCO-9

Single-arm prospective registry studying Resolute Onyx™ DES in small-vessel PCI (N = 302)

Complex patient population

  • 65% acute coronary syndrome
  • 39% diabetic

0% stent thrombosis and low rate of CD-TLR at one year8

Bar chart showing the event rates at one year in the DISCO-9 study

Resolute Onyx™ DES was safe and effective in complex, small coronary vessels.8

All-comer

Medtronic DES have shown outstanding safety and efficacy in a complex, real-world patient population.10

BIONYX

Prospective, single-blinded trial with 1:1 randomisation to look at Resolute Onyx™ DES durable polymer coating versus Orsiro DES bioresorbable coating — stratifying for gender and diabetes (N = 2,470)

Definite or probable stent thrombosis

Bar chart showing the definite or probable stent thrombosis at one, two, and three years from the BIONYX trial

Long-term safety shown at three-year follow-up with Resolute Onyx™ DES.9–11

Additional resources

Introducing Onyx Frontier™ DES

Our latest DES is engineered to deliver.

Bifurcation education

View five techniques that highlight Resolute Onyx DES through endoscopic imaging captured inside an isolated and reanimated beating porcine heart.

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™Third-party brands are trademarks of their respective owners.

Resolute Onyx™ DES received CE mark approval for 1-month DAPT in HBR patients in 2020.

References

1

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.

2

Windecker S, et al. Final Two-Year Results from the Randomized Onyx ONE Trial in High Bleeding Risk Patients Treated with 1-month DAPT. Presented at ACC 2021.

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.

4

Resolute Onyx DES IFU M981345A001 Rev. AA..

5

Tarantini G, et al. The ROLEX Registry (Revascularization Of LEft Main With Resolute onyX). Presented at PCR 2022. Investigator-initiated study funded by Medtronic.

6

Hildick-Smith D, Egred M, Banning A, et al. The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN). Eur Heart J. October 1, 2021;42(37):3829-3839.

7

Based on bench test data on file at Medtronic (method 10036340DOC). May not be indicative of clinical performance. Minimum of N=10 of each DES tested: Resolute Onyx DES, Orsiro DES, XIENCE Alpine™* DES, SYNERGY™* DES, Ultimaster™* DES.

8

Cuellas C, et al. Use of a Zotarolimus-eluting stent for small vessel disease (DISCO 9 Study). Presented at PCR 2021.

9

Buiten RA, Ploumen EH, Zocca P, et al. Thin Composite-Wire-Strut Zotarolimus-Eluting Stents Versus Ultrathin-Strut Sirolimus-Eluting Stents in BIONYX at 2 Years. JACC Cardiovasc Interv. May 2020;13(9):1100-1109.

10

Von Birgelen C, Zocca P, Buiten RA, et al. Thin composite wire strut, durable polymer-coated (Resolute Onyx) versus ultrathin cobalt-chromium strut, bioresorbable polymer-coated (Orsiro) drug-eluting stents in allcomers with coronary artery disease (BIONYX): an international, single-blind, randomised non-inferiority trial. Lancet. October 6, 2018;392(10154):1235-1245.

11

Ploumen E, et al. Data presented at ACC 2021. Investigator-initiated study funded by Medtronic, BIOTRONIK.

Brief statement

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