Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent
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CLINICAL INVESTIGATION
ARTERIAL INTERVENTIONS
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 Stefan Mu¨ller-Hu¨lsbeck1 • Andrew Benko2 • Yoshimitsu Soga3 • Masahiko Fujihara4 • Osamu Iida5 • Anvar Babaev6 • David O’Connor7 • Thomas Zeller8 • Daniel D. Dulas9 • Juan Diaz-Cartelle10 • William A. Gray11
Received: 13 August 2020 / Accepted: 21 October 2020 Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2020
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 Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00270-020-02693-1) contains supplementary material, which is available to authorized users. & Stefan Mu¨ller-Hu¨lsbeck [email protected] 1
Ev. Luth. Diakonissenanstalt Flensburg, Flensburg, Germany
2
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada
3
Kokura Memorial Hospital, Kitakyushu, Japan
4
Kishiwada Tokushukai Hospital, Osaka, Japan
5
Kansai Rosai Hospital, Amagasaki, Japan
6
New York University Medical Center, New York, NY, USA
7
Hackensack University Medical Center, Hackensack, NJ, USA
8
Universita¨ts-Herzzentrum Freiberg-Bad Krozingen, Bad Krozingen, Germany
9
Metropolitan Cardiology Consultants, Coon Rapids, MN, USA
10
Boston Scientific, Marlborough, MA, USA
11
Lankenau Heart Institute, Wynnewood, PA, USA
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 sus
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