Abstract
Purpose
The purpose of the study is to report 12-month efficacy and safety results from the subgroup of Japanese patients in the prospective IMPERIAL 2:1 randomized controlled trial (RCT).
Methods
The global IMPERIAL RCT was designed to compare performance of the Eluvia Drug-Eluting Vascular Stent System (Boston Scientific, Marlborough, MA, USA) with the Zilver PTX Drug-Eluting Peripheral Stent (Cook Medical, Bloomington, IN, USA) for treatment of femoropopliteal artery lesions. Patients with symptomatic (Rutherford category 2–4) disease were included. Post-procedural technical success was defined as delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% by visual assessment. Twelve-month assessments included primary patency (core laboratory-assessed duplex ultrasound peak systolic velocity ratio ≤ 2.4 in the absence of clinically driven TLR or bypass of the target lesion) and major adverse events (MAEs).
Results
Fifty-six patients in the Eluvia group and 28 in the Zilver PTX group were treated at Japanese centers. Mean lesion length was 91.8 ± 38.0 mm for Eluvia and 87.4 ± 41.7 mm for Zilver PTX. Technical success was 100% for both groups. At 12 months, the observed primary patency rate was 90.9% for Eluvia and 84.6% for Zilver PTX. The 12-month MAE rate was 1.8% for Eluvia and 7.7% for Zilver PTX. All MAEs were clinically driven TLRs.
Conclusion
The results show excellent vessel patency and a good safety profile up to 1 year in the subgroup of Japanese patients in IMPERIAL treated with Eluvia for femoropopliteal artery disease.
Level of Evidence
Level 3; subgroup analysis of randomized trial.
Clinical Trial Registration
ClinicalTrials.gov, identifier NCT02574481.
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Acknowledgements
The authors thank the following Boston Scientific employees for their assistance: H. Terry Liao, PhD designed the statistical analysis plan, Naoko Takahashi and Rieko Kuribayashi provided clinical trial management, and Elizabeth J. Davis, PhD provided medical writing assistance.
Funding
This study was sponsored by Boston Scientific, Marlborough, MA, USA.
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Yoshimitsu Soga serves as an advisor to Boston Scientific. Masahiko Fujihara, Osamu Iida, Daizo Kawasaki, Keisuke Hirano, Hiroyoshi Yokoi, Akira Miyamoto, Kimihiko Kichikawa, Masato Nakamura and 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.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional Review Board, Independent Ethics Committee, or Research Ethics Board applicable to each study site, and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
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Soga, Y., Fujihara, M., Iida, O. et al. Japanese Patients Treated in the IMPERIAL Randomized Trial Comparing Eluvia and Zilver PTX Stents. Cardiovasc Intervent Radiol 43, 215–222 (2020). https://doi.org/10.1007/s00270-019-02355-x
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DOI: https://doi.org/10.1007/s00270-019-02355-x