Complex percutaneous coronary intervention (PCI)

Resolute Onyx™ drug-eluting stent is optimised for complex PCI

Alert Indications, Safety, and Warnings

Overview

Patients and lesions can be complex, increasing the burden on your practice. A stent that’s optimised for these challenges and proven in multiple applications is ideal.

Left Main PCI

Optimised for left main and other extra-large vessels

  • Complex, left main (LM) PCI can be associated with periprocedural complications and restenosis.
  • Successful LM revascularisation requires a stent that can expand under stress without compromise.

Resolute Onyx DES at 6.0 mm maximum expansion†

Resolute Onyx shown at maximum expansion, zooming in on its struts which still have room to expand

Resolute Onyx DES' 4.5 and 5.0 mm diameters:

  • Expand to 6.0 mm† for optimal deployment with even scaffolding1
  • Provide the sustained radial strength needed to handle the left main artery’s elasticity1

SYNERGY MEGATRON™* DES
at 6.0 mm

SYNERGY MEGATRON at maximum expansion with a zoom in on its straightened struts at their maximum expansion limit

SYNERGY MEGATRON DES' post-dilatation to 6.0 mm causes the struts to straighten as they approach their expansion limit.

Radial strength comparison
at 6.0 mm1

(Higher is better)

Orange and gray bar chart that compares Resolute Onyx radial strength to SYNERGY MEGATRON

EBC Main study2

Resolute Onyx is the only DES with randomised data supporting provisional and dual-stent strategies in LM bifurcation PCI.

  • First randomised trial based on European Bifurcation Club (EBC) Consensus, comparing a provisional to a planned dual-stent strategy in LM bifurcation PCI
  • 467 patients with true LM bifurcation disease enrolled in Europe
  • Resolute Onyx DES was chosen because of its 4.5 and 5.0 mm diameters, which now expand to 6.0 mm†
Orange and gray bar chart that shows the results of the EBC Main study

Results

  • 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
pdf EBC Main Results (.pdf)

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For reference only in markets where the Resolute Onyx coronary stent and the 0.25 mm expansion have been approved.

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Bifurcation PCI

Optimised for bifurcation PCI

  • Bifurcation stenting is complex and associated with a high risk of stent thrombosis and restenosis.3
  • Main branch optimisation without compromising the side branch requires a flexible stent that can facilitate the passage of a secondary device across a broad range of techniques and anatomies.

Resolute Onyx DES' single-wire design increases flexibility and conformability for optimal strut apposition, which reduces arterial injury and thrombus formation.1

Resolute Onyx DES 3.0 mm x 18 mm

Black and white model showing low average of percentage of malapposed Resolute Onyx struts highlighted in red

4.3 ± 1.6%

SYNERGY DES 3.0 mm x 20 mm

Black and white model showing high average of percentage of malapposed SYNERGY struts highlighted in red

13.2 ± 5.2%

Review the Data

Average percentage of malapposed struts in simulated bifurcation anatomies.1

Smooth side branch access

  • Other drug-eluting stents feature irregular cell shapes which may obstruct wire or catheter advancement through the cell’s opening.
  • Resolute Onyx DES has round struts to create a smooth passage when accessing the side branch while lowering the propensity to catch,1 as seen in the corresponding video from our Bifurcation Exploration website.
  • The Bifurcation Exploration website features five techniques performed with Resolute Onyx DES inside an isolated and reanimated beating porcine heart.
  • Medtronic created this resource with the EBC and The Visible Heart™ Lab.
Explore Bifurcation Site

Footage of Resolute Onyx DES within an isolated and reanimated beating porcine heart.

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Small Vessel PCI

Optimised for extra-small vessels

  • Diseased, extra-small coronary arteries with diameters between 2.0–2.25 mm are encountered frequently and, despite size, may require treatment.
  • Resolute Onyx is available in a 2.0 mm size with the lowest crossing profile of any DES, making it ideal for treating extra-small vessels.1
  • Single-wire design gives it a fluid range of motion and provides the flexibility needed for best-in-class deliverability, helping to reach distal, highly occluded, extra-small vessels.1
  • 2.0 mm expands to 3.50 mm† with minimal foreshortening for tapered and extra-small vessels.1
  • Resolute Onyx DES demonstrated 2% target lesion revascularization and 0% stent thrombosis in a complex, small-vessel population.4

 Extra-small vessel deliverability comparison1

(Lower is better)

Orange and gray bar chart comparing deliverability of Resolute Onyx to XIENCE, SYNERGY, and Orsiro DES in extra-small vessels

For reference only in markets where the Resolute Onyx coronary stent and the 0.25 mm expansion have been approved.

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1-month DAPT in HBR Patients

Optimised for HBR patients who may require 1-month dual antiplatelet therapy (DAPT)

  • Up to 40% of patients are at high bleeding risk while 20% may need to interrupt or discontinue DAPT earlier than prescribed.5,6
  • To be confident with this decision, a fast-healing stent that’s proven in this patient population is important.
  • Resolute Onyx DES is conformable for superior strut apposition.1
  • BioLinx™ biocompatible polymer provides superior thromboresistance.7
  • Optical coherence tomography (OCT) data showed 90% strut coverage at 30 days, proving fast healing which may enable a shorter DAPT duration8 and providing the foundation for the Onyx ONE Global Trial.
  • Onyx ONE Global Trial studied real-world, high bleeding risk (HBR) patients on 1-month DAPT treated with a Resolute Onyx DES or a BioFreedom™* DCS.
  • Results showed that Resolute Onyx DES was safe and effective in HBR patients on 1-month DAPT.9

Onyx ONE enrolled real-world patients

Patient and lesion complexity characteristics

Onyx ONE Global Trial

Onyx ONE Clear Analysis

Number of Resolute Onyx DES patients studied

1003

1506

Percentage of acute coronary syndrome (ACS) patients included

53%

49%

Percentage of atrial fibrillation (AF) patients included

33%

36%

Percentage of diabetic patients included

39%

39%

Percentage of B2/C lesions

80%

79%

Average stented length

38 mm

37 mm

Percentage of moderate/severe calcified lesions

46%

50%
See More Data

Deployed to 5.75 mm1§

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Additional Resources

Onyx ONE Global Trial

First randomised, 1-month DAPT trial comparing a DES to a DES in ~2000 high bleeding risk patients on 1-month DAPT.

Review the Data

See exclusive features and benefits

Resolute Onyx DES is different by design.

See Key Differences

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 and FDA approval for increased expansion in 2020.

References

1

Based on bench test data on file at Medtronic. May not be indicative of clinical performance.

2

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. Published online May 18, 2021.

3

Gwon HC. Understanding the Coronary Bifurcation Stenting. Korean Circ J. June 2018;48(6):481–491.

4

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

5

Windecker S. Stent Selection for 1-3 Month DAPT: Current Evidence Ongoing Studies. Presented at TCT 2018; San Diego, CA.

6

Silber S, Kirtane AJ, Belardi JA, et al. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. August 1, 2014;35(29):1949-1956.

7

Jinnouchi H, Sato Y, Cheng Q, et al. Thromboresistance and endothelial healing in polymer-coated versus polymer-free drug-eluting stents: Implications for short-term dual anti-platelet therapy. Int J Cardiol. March 15, 2021;327:52-57.

8

Roleder T, Kedhi E, Berta B, et al. Short-term stent coverage of second-generation zotarolimus-eluting durable polymer stents: Onyx one-month optical coherence tomography study. Adv Interv Cardiol. 2019;15(2):143-150.

9

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.