24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent

Osamu Iida, Masahiko Fujihara, Daizo Kawasaki, Shinsuke Mori, Hiroyoshi Yokoi, Akira Miyamoto, Kimihiko Kichikawa, Masato Nakamura, Takao Ohki, Juan Diaz-Cartelle, Stefan Müller-Hülsbeck, William A Gray, Yoshimitsu Soga, Osamu Iida, Masahiko Fujihara, Daizo Kawasaki, Shinsuke Mori, Hiroyoshi Yokoi, Akira Miyamoto, Kimihiko Kichikawa, Masato Nakamura, Takao Ohki, Juan Diaz-Cartelle, Stefan Müller-Hülsbeck, William A Gray, Yoshimitsu Soga

Abstract

Purpose: The purpose of the study is to report 24-month efficacy and safety results for the Japanese patient cohort in a prospective randomized controlled trial (RCT) of drug-eluting stent (DES) use for peripheral artery disease.

Materials and methods: Patients in the global IMPERIAL RCT had femoropopliteal lesions treated with either the Eluvia DES (Boston Scientific, Marlborough, MA, USA) or the Zilver PTX drug-coated stent (Cook Medical, Bloomington, IN, USA). At 24 months, assessments included duplex ultrasound imaging for core laboratory vessel patency measurement, target lesion revascularization (TLR) rates, and clinical outcome measures.

Results: The Japanese cohort included 84 patients (56 treated with Eluvia and 28 with Zilver PTX). The clinically driven TLR rates were 5.6% (3/54) and 18.5% (5/27) for patients treated with Eluvia and Zilver PTX, respectively (difference -13.0%, 95%CI -28.8, 2.9%; p = 0.11). The Kaplan-Meier estimates for freedom from clinically driven TLR at 24 months were 94.3% for patients who received Eluvia and 80.4% for those who received Zilver PTX (log rank p = 0.05), and for primary patency they were 88.5% and 80.4%, respectively (log rank p = 0.28). Mortality rates were 5.6% (3/54) and 11.1% (3/27); p = 0.39. Rutherford classification improved by at least one category without TLR for 91.8% (45/49) and 68.2% (15/22) of patients (p = 0.03). Walking impairment score improvements were sustained over time.

Conclusion: The results at 24 months support the efficacy and safety of DES in Japanese patients, with sustained clinical improvements and numerically fewer reinterventions for those treated with Eluvia.

Clinical trial registration: Clinicaltrials.gov identifier NCT02574481. https://ichgcp.net/clinical-trials-registry/NCT02574481 LEVEL OF EVIDENCE: EBM Level III; cohort analysis of randomized trial.

Keywords: Drug-eluting stent; Paclitaxel; Peripheral arterial disease; Superficial femoral artery; Vascular patency.

Conflict of interest statement

Osamu Iida reports consulting for Boston Scientific.

Masahiko Fujihara reports consulting for Boston Scientific.

Daizo Kawasaki reports consulting for Boston Scientific.

Mori Shinsuke has no financial conflicts of interest to disclose.

Hiroyoshi Yokoi reports consulting for Boston Scientific.

Akira Miyamoto reports consulting for Boston Scientific.

Kimihiko Kichikawa reports consulting for Boston Scientific.

Masato Nakamura reports consulting for Boston Scientific.

Takao Ohki reports consulting for Boston Scientific.

Juan Diaz-Cartelle is an employee of and owns stock in Boston Scientific.

William A. Gray serves as an advisor to Boston Scientific.

Stefan Müller-Hülsbeck serves as a consultant and has received honoraria and travel grants from Boston Scientific, and has received fees from Terumo.

Yoshimitsu Soga serves as an advisor to Boston Scientific.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Kaplan–Meier estimate of freedom from CD-TLR and standard errors
Fig. 2
Fig. 2
Kaplan–Meier estimate of primary patency and standard errors
Fig. 3
Fig. 3
Rutherford category distribution

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Source: PubMed

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