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1000
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Abstract/Summary
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<jats:title>Abstract</jats:title><jats:sec>
<jats:title>Purpose</jats:title>
<jats:p>To investigate the long-term results of the Eluvia drug-eluting stent (DES) implantation for femoropopliteal arterial disease, including the ‘halo’ phenomenon. Long-term data of DES is scarce. A focal reaction (‘halo’) following Eluvia DES deployment has been described. However, the long-term clinical impact of this phenomenon remains unclear.</jats:p>
</jats:sec><jats:sec>
<jats:title>Methods</jats:title>
<jats:p>This prospective, non-randomized, single-arm study included 130 consecutive patients treated with an Eluvia DES for symptomatic femoropopliteal disease between March 2016 and December 2018. Clinical outcomes and imaging were assessed after 6 months and annually thereafter for up to 5 years. The primary outcome measure was primary patency. Secondary outcomes were freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, overall survival and amputation-free survival rates.</jats:p>
</jats:sec><jats:sec>
<jats:title>Results</jats:title>
<jats:p>The primary patency was 65% at 5 years. The freedom from CD-TLR and from major amputation at 5 years was 79 and 96%, respectively. The overall survival and amputation-free survival rates were 88 and 83% at 60 months, respectively. Out of the 27 patients with a halo sign, two showed an increased (7.4%) and 6 (22.2%) a decreased diameter. In 19 cases (70.4%), the diameter remained unchanged at the latest follow-up. The presence of the ‘halo’ sign was associated with increased primary patency (87% versus 59%, HR: 2.48, 95%CI 1.19–5.16, <jats:italic>P</jats:italic> = .015).</jats:p>
</jats:sec><jats:sec>
<jats:title>Conclusions</jats:title>
<jats:p>The presented patient cohort treated with the Eluvia DES for femoropopliteal artery lesions indicates durable efficacy and a good safety profile regardless of the halo phenomenon. The results need to be confirmed in a larger patient cohort.</jats:p>
</jats:sec><jats:sec>
<jats:title>Level of Evidence III</jats:title>
<jats:p>Non-randomized controlled cohort/follow-up study.</jats:p>
</jats:sec><jats:sec>
<jats:title>Graphical Abstract</jats:title>
</jats:sec>
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1000
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Hinweis
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DeepGreen-ID: bfec8e676e824806a7a1b6dc61601c3b ; metadata provieded by: DeepGreen (https://www.oa-deepgreen.de/api/v1/), LIVIVO search scope life sciences (http://z3950.zbmed.de:6210/livivo), Crossref Unified Resource API (https://api.crossref.org/swagger-ui/index.html), to.science.api (https://frl.publisso.de/), ZDB JSON-API (beta) (https://zeitschriftendatenbank.de/api/), lobid - Dateninfrastruktur für Bibliotheken (https://lobid.org/resources/search)
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