24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2021-07-07

AUTHORS

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

PurposeThe 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 methodsPatients 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.ResultsThe 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.ConclusionThe 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 RegistrationClinicaltrials.gov identifier NCT02574481.https://clinicaltrials.gov/ct2/show/NCT02574481Level of EvidenceEBM Level III; cohort analysis of randomized trial. More... »

PAGES

1367-1374

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00270-021-02901-6

DOI

http://dx.doi.org/10.1007/s00270-021-02901-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1139492447

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/34235560


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37 PurposeThe purpose
38 RCTs
39 Rutherford classification
40 TLR
41 TLR rate
42 Zilver PTX
43 analysis
44 artery disease
45 assessment
46 categories
47 classification
48 clinical improvement
49 clinical outcome measures
50 cohort
51 cohort analysis
52 disease
53 drug eluting stents
54 drug-coated stents
55 drug-eluting stent use
56 duplex ultrasound
57 efficacy
58 eluvium
59 estimates
60 femoropopliteal lesions
61 freedom
62 improvement
63 lesion revascularization rate
64 lesions
65 level III
66 materials
67 measurements
68 measures
69 months
70 mortality rate
71 outcome measures
72 patency
73 patient cohort
74 patients
75 peripheral artery disease
76 primary patency
77 purpose
78 randomized study
79 rate
80 reintervention
81 results
82 revascularization rates
83 safety
84 safety of DES
85 safety results
86 score improvement
87 stent use
88 stents
89 study
90 sustained clinical improvement
91 time
92 trials
93 ultrasound
94 use
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