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 with approved indication 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 approved by the FDA 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
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
Complex patient population
- 59% multivessel disease
- 53% acute coronary syndrome
- 30% diabetic
Resolute Onyx™ DES was safe and effective in complex, left main PCI with 99% device success.5
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
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
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.9
Additional resources
Introducing Onyx Frontier™ DES
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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
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.
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