Two-Year Results of the ILLUMINA Study: An Interview With Andrea Kahlberg, MD

VASCULAR DISEASE MANAGEMENT 2022;20(1):E19-E20

At the 2022 VEITH Symposium in New York City, Andrea Kahlberg, MD, from the Department of Vascular Surgery, Vita-Salute University, San Raffaele Scientific Institute in Milan, Italy, presented the 2-year results of the Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy (ILLUMINA) trial. The study assessed the 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.¹

Vascular Disease Management spoke with Dr. Kahlberg to discuss the results of this important study.

Can you provide a background of the ILLUMINA study?

There’s a new self-expanding stent for the superficial femoral artery called the NiTiDES stent system (Alvimedica). It's a sirolimus-eluting stent. It's the only stent available today eluting sirolimus for this segment and has different technological innovations as compared to other platforms. It was the object of the first-in-human study, called ILLUMINA, that was carried out in 10 European centers, enrolling 100 patients. And the 2-year results are now available.

What makes this stent different than others that are on the market?

First is the abluminal reservoir technology, which is the presence of these small cells that are distributed on the metal struts of the stent in which the drug is loaded. They protect the drug and the drug is released in a controlled and sustained way without using any polymers. This is a unique feature of the stent. The second important thing is the formulation of the drug. This is sirolimus with fatty acids, called amphilimus. It is a formulation that allows the drug to be absorbed by the arterial wall in a better way as compared to the classic, normal nonformulated drugs. And the third thing is a carbon coating of the metal struts that reduces the inflammatory reaction of the body. These are the three main technological things that only this stent has.

Can you recap the study findings after 2 years?

The 2-year results have shown 83% of primary patency at 2 years. And the other important result is clinically driven target lesion revascularization (CD-TLR) rates. In diabetic patients, the CD-TLR was about 97% at 2 years. So if we compare these results with one of the most famous recent trials on the superficial femoral artery (SFA), that is the IMPERIAL trial, we can say that for the primary patency, 83% of patency is much better than the Zilver PTX cohort of the IMPERIAL trial and is similar to the Eluvia results in the IMPERIAL trial. And CD-TLR at 2 years is really the best ever published, so it is significantly lower than the TLR reported in the IMPERIAL trial for both the Zilver PTX platform and the Eluvia DES.

What are the key takeaways from the study?

This is the first and only sirolimus-based peripheral DES available. It has been studied in this ILLUMINA trial, the first-in-human trial that showed very high performance at 2 years. These data are really good even if compared with recent important data by other trials on the SFA. Outcomes are particularly interesting in the diabetic population. And of course, the next post-market registry results will be useful to confirm these initial promising results.

Has the outcome of this study changed the way that you practice?

At this time, this new kid on the block is probably one of the most-used stents in my experience, since it's commercially available.

What’s next for the ILLUMINA study?

Next is a post-market registry, in which we will collect a larger series of patients.

REFERENCE

1. Steiner S, Honton B, Langhoff R, et al. 2-year results with a sirolimus-eluting self-expanding stent for femoropopliteal lesions: the first-in-human ILLUMINA study. JACC Cardiovasc Interv. 2022;15(6):618-626. doi:10.1016/j.jcin.2021.12.034