Skip to main content

Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free Drug-Coated Stent

CardioVascular and Interventional Radiology volume 44, pages 368–375 (2021)Cite this article

Abstract

Purpose

To report additional endpoints, including 2-year primary patency, patient outcomes, and safety results, as well as the initial assessment of hypoechogenic halo from the IMPERIAL Randomized Controlled Trial (RCT).

Materials and methods

IMPERIAL RCT is a prospective, randomized (2:1), multicenter study of patients with symptomatic femoropopliteal artery lesions (length 30–140 mm, Rutherford category 2–4) treated with the Eluvia paclitaxel-eluting nitinol stent or the Zilver PTX paclitaxel-coated stent. Two-year follow-up included patency, safety, and mortality assessments and core laboratory-reviewed B-mode ultrasound imaging to screen for hypoechogenic halo in the stented segment, and assess blood flow.

Results

At 24 months, all-cause mortality was 7.1% (21/295) for Eluvia and 8.3% (12/145) for Zilver PTX (P = 0.6649). The clinically driven target lesion revascularization rate was significantly less for patients treated with Eluvia vs Zilver PTX (12.7% vs 20.1%; P = 0.0495). The Kaplan–Meier estimate of primary patency at 24 months was 83.0% for Eluvia and 77.1% for Zilver PTX (log rank P = 0.1008). Transverse ultrasound imaging was implemented during the 24-month follow-up window and was evaluable for 27.5% (128/465) of patients. Hypoechogenic halo prevalence rates did not differ significantly between Eluvia and Zilver PTX study arms (33.7% [29/86] vs 21.4% [9/42]; P = 0.153). In no case was flow documented within the halo; no adverse events were associated with these ultrasound findings.

Conclusion

Two-year follow-up suggests a sustained advantage for Eluvia for avoiding target lesion revascularization. Initial hypoechogenic halo assessment showed no difference in prevalence between the study arms, no flow within the halo, and no associated adverse events.

Clinical trial Registration: clinicaltrials.gov identifier NCT02574481. Date of registration: October 14, 2015.

Level of evidence: Level 1; randomized controlled trial.

This is a preview of subscription content, access via your institution.

Access options

Buy single article

Instant access to the full article PDF.

USD 39.95

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Fig. 1
Fig. 2
Fig. 3
Fig. 4

References

  1. Malgor RD, Alahdab F, Elraiyah TA, et al. A systematic review of treatment of intermittent claudication in the lower extremities. J Vasc Surg. 2015;61:54S-73S.

    Article  Google Scholar 

  2. Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the zilver PTX randomized trial. Circulation. 2016;133:1472–83.

    Article  CAS  Google Scholar 

  3. Gray WA, Keirse K, Soga Y, et al. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet. 2018;392:1541–51.

    Article  CAS  Google Scholar 

  4. Golzar J, Soga Y, Babaev A, et al. Effectiveness and safety of a paclitaxel-eluting stent for superficial femoral artery lesions up to 190 mm: one-year outcomes of the single-arm IMPERIAL long lesion substudy of the eluvia drug-eluting stent. J Endovasc Ther. 2020;27:296–303.

    Article  Google Scholar 

  5. Bisdas T, Beropoulis E, Argyriou A, Torsello G, Stavroulakis K. 1-year all-comers analysis of the eluvia drug-eluting stent for long femoropopliteal lesions after suboptimal angioplasty. JACC Cardiovasc Interv. 2018;11:957–66.

    Article  Google Scholar 

  6. Laird JR, Schneider PA, Tepe G, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol. 2015;66:2329–38.

    Article  Google Scholar 

  7. Sridharan ND, Boitet A, Smith K, et al. Cost-effectiveness analysis of drug-coated therapies in the superficial femoral artery. J Vasc Surg. 2018;67:343–52.

    Article  Google Scholar 

  8. Sartipy F, Sigvant B, Lundin F, Wahlberg E. Ten year mortality in different peripheral arterial disease stages: a population based observational study on outcome. Eur J Vasc Endovasc Surg. 2018;55:529–36.

    Article  Google Scholar 

  9. Tato F, Hoffmann U. Clinical presentation and vascular imaging in giant cell arteritis of the femoropopliteal and tibioperoneal arteries. Analysis of four cases. J Vasc Surg. 2006;44:176–82.

    Article  Google Scholar 

  10. Muller-Hulsbeck S, Link J, Schwarzenberg H, et al. MR imaging signal-intensity abnormalities after placement of arterial endoprostheses. AJR Am J Roentgenol. 1997;169:743–8.

    Article  CAS  Google Scholar 

  11. D’Arrigo G, Giaquinta A, Virgilio C, Davi A, Pierfrancesco V, Veroux M. Nickel allergy in a patient with a nitinol stent in the superficial femoral artery. J Vasc Interv Radiol. 2014;25:1304–6.

    Article  Google Scholar 

Download references

Acknowledgements

Results from the 2-year analysis of the IMPERIAL RCT were presented at VIVA 2019, Nov 4-7, 2019, Las Vegas, NV, USA. The authors thank the following Boston Scientific employees for their assistance: Nicole Kilburn (clinical trial management), H. Terry Liao, PhD (statistical analysis plan design), and Elizabeth J. Davis, PhD (medical writing).

Funding

This study was funded by Boston Scientific Corporation, Marlborough, MA, USA. Employees of and consultants to the funding body were involved in the design of the study, analysis, and interpretation of data and in writing the manuscript.

Author information

Authors and Affiliations

  1. Ev. Luth. Diakonissenanstalt Flensburg, Flensburg, Germany

    Stefan Müller-Hülsbeck

  2. Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada

    Andrew Benko

  3. Kokura Memorial Hospital, Kitakyushu, Japan

    Yoshimitsu Soga

  4. Kishiwada Tokushukai Hospital, Osaka, Japan

    Masahiko Fujihara

  5. Kansai Rosai Hospital, Amagasaki, Japan

    Osamu Iida

  6. New York University Medical Center, New York, NY, USA

    Anvar Babaev

  7. Hackensack University Medical Center, Hackensack, NJ, USA

    David O’Connor

  8. Universitäts-Herzzentrum Freiberg-Bad Krozingen, Bad Krozingen, Germany

    Thomas Zeller

  9. Metropolitan Cardiology Consultants, Coon Rapids, MN, USA

    Daniel D. Dulas

  10. Boston Scientific, Marlborough, MA, USA

    Juan Diaz-Cartelle

  11. Lankenau Heart Institute, Wynnewood, PA, USA

    William A. Gray

Authors
  1. Stefan Müller-Hülsbeck
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Andrew Benko
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Yoshimitsu Soga
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Masahiko Fujihara
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Osamu Iida
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Anvar Babaev
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. David O’Connor
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Thomas Zeller
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Daniel D. Dulas
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Juan Diaz-Cartelle
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. William A. Gray
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

Stefan Müller-Hülsbeck, Juan Diaz-Cartelle, and William A. Gray contributed to the study conception and design. Stefan Müller-Hülsbeck, Andrew Benko, Yoshimitsu Soga, Masahiko Fujihara, Osamu Iida, Anvar Babaev, David O’Connor, Thomas Zeller, Daniel D. Dulas, and William A. Gray contributed to data collection. Stefan Müller-Hülsbeck and Juan Diaz-Cartelle guided the development of the first draft of the manuscript. All authors commented on previous versions of the manuscript and read and approved the final manuscript.

Corresponding author

Correspondence to Stefan Müller-Hülsbeck.

Ethics declarations

Conflict of Interest

Stefan Müller-Hülsbeck, MD, PhD serves as a consultant and has received honoraria and travel grants from Boston Scientific, and has received fees from Terumo. Andrew Benko, MD reports receiving research funding from Medtronic and Soundbite Medical, is a shareholder in Soundbite Medical, and has received speaking fees from Medtronic, Cordis, and Boston Scientific. Yoshimitsu Soga, MD serves as an advisor to Boston Scientific. Masahiko Fujihara, MD reports consulting for Boston Scientific. Osamu Iida, MD reports consulting for Boston Scientific. Anvar Babaev, MD reports receiving honoraria for physician training from Boston Scientific, Abbott, Medtronic, and Cook. David O’Connor, MD reports receiving honoraria for physician training from Cardiovascular Systems Incorporated, Abbott, and Boston Scientific. Thomas Zeller, MD reports receiving honoraria from: Abbott Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, TriReme, Veryan, Shockwave, Biotronik, B. Braun, Efemoral, consulting for: Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Spectranetics, Veryan, Intact Vascular, Veryan. and holding common stock in: QT Medical. Daniel D. Dulas, MD declares that he has no conflict of interest. Juan Diaz-Cartelle, MD is an employee of and owns stock in Boston Scientific. William A. Gray, MD serves as an advisor to Boston Scientific.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol was approved by the applicable Institutional Review Board (IRB), ethics committee, or research ethics board for each study site.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Consent for Publication

For this type of study, consent for publication is not required.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary file1 (PDF 102 kb)

Supplementary file2 (PDF 128 kb)

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Müller-Hülsbeck, S., Benko, A., Soga, Y. et al. Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free Drug-Coated Stent. Cardiovasc Intervent Radiol 44, 368–375 (2021). https://doi.org/10.1007/s00270-020-02693-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00270-020-02693-1

Keywords

  • Drug-eluting stent
  • Paclitaxel
  • Peripheral arterial disease
  • Superficial femoral artery
  • Vascular patency