Japanese Patients Treated in the IMPERIAL Randomized Trial Comparing Eluvia and Zilver PTX Stents View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-11-05

AUTHORS

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

ABSTRACT

PurposeThe 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).MethodsThe 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).ResultsFifty-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.ConclusionThe 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 EvidenceLevel 3; subgroup analysis of randomized trial.Clinical Trial RegistrationClinicalTrials.gov, identifier NCT02574481. More... »

PAGES

215-222

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00270-019-02355-x

DOI

http://dx.doi.org/10.1007/s00270-019-02355-x

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1122334473

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/31690980


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