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Multicenter Study
. 2022 Mar 28;15(6):618-626.
doi: 10.1016/j.jcin.2021.12.034. Epub 2022 Feb 23.

2-Year Results With a Sirolimus-Eluting Self-Expanding Stent for Femoropopliteal Lesions: The First-in-Human ILLUMINA Study

Sabine Steiner  1 , Benjamin Honton  2 , Ralf Langhoff  3 , Roberto Chiesa  4 , Andrea Kahlberg  4 , Marcus Thieme  5 , Thomas Zeller  6 , Philippe Garot  7 , Philippe Commeau  8 , Alberto Cremonesi  9 , Enrico Maria Marone  10 , Antoine Sauguet  2 , Dierk Scheinert  11
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Free article
Multicenter Study

2-Year Results With a Sirolimus-Eluting Self-Expanding Stent for Femoropopliteal Lesions: The First-in-Human ILLUMINA Study

Sabine Steiner et al. JACC Cardiovasc Interv. .
Free article

Abstract

Objectives: The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics.

Background: DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating.

Methods: Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes.

Results: At 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores.

Conclusions: The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676).

Keywords: drug-eluting stent(s); patency; peripheral vascular disease; sirolimus; superficial femoral artery disease.

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Conflict of interest statement

Funding Support and Author Disclosures The study was funded by Alvimedica. Dr Steiner has served as a consultant for Bayer, Boston Scientific, and Cook Medical; and received research funding from C.R. Bard. Dr Chiesa has served as a consultant for W.L. Gore and Cordis. Dr Kahlberg has served as a consultant or lecturer for Abbott, Alvimedica, Biovascular, Boston Scientific, Cordis, Medtronic, Terumo, and W.L. Gore. Dr Zeller has received honoraria from Abbott Vascular, Veryan, Biotronik, Boston Scientific, Cook Medical, W.L. Gore and Associates, Medtronic, Philips-Spectranetics, and Shockwave; and has served as a consultant for Boston Scientific, W.L. Gore and Associates, Medtronic, Veryan, Intact Vascular, Shockwave, Bayer, and Vesper Medical; and owns common stock in QT Medical. Dr Commeau has served as a consultant for Medtronic, Abbott, Terumo, Boston SCI, and Edwards Lifesciences. Dr Cremonesi has served as a consultant or on the advisory board for Abbott, Medtronic, Boston Scientific, and Terumo. Dr Marone has served as a consultant for QMedics. Dr Scheinert has served as a consultant or on the advisory board for Abbott, Biotronik, Boston Scientific, Cook Medical, Cordis, CR Bard, Gardia Medical, Medtronic/Covidien, TriReme Medical, Trivascular, and Upstream Peripheral Technologies. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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