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Short Report
12 April 2024

Polymer-based drug-eluting stent treatment extends the time to reintervention for patients with symptomatic femoropopliteal artery disease: clinical evidence and potential economic value

Authors: William A Gray https://orcid.org/0000-0003-4676-2839 [email protected], Yoshimitsu Soga https://orcid.org/0000-0003-1931-5769, Masahiko Fujihara, Osamu Iida https://orcid.org/0000-0001-6829-7304, Anvar Babaev, Daizo Kawasaki, Thomas Zeller https://orcid.org/0000-0003-2704-3871, David O'Connor, Michael R Jaff https://orcid.org/0000-0002-3772-5887, Anna M Chavez, and Stefan Müller-HülsbeckAuthor Info & Affiliations
Volume 13, Number 6
https://doi.org/10.57264/cer-2024-0025
PDFFormats

Abstract

Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer-based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer-coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n = 465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5 years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5 years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; p = 0.0058) for patients treated with Eluvia (n = 56) than for those treated with Zilver PTX (n = 30). Through the 5-year study follow-up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p = 0.3540) and mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.

Shareable abstract

Long-term follow-up data from the randomized IMPERIAL trial showed that treatment with the Eluvia drug-eluting stent delayed lesion restenosis and extended the time before reintervention was needed. Such a delay could lead to cost savings depending on the surveillance period, as shown in cost-avoidance scenarios based on costs associated with reintervention episodes of care.

Plain language summary

What is this article about?

The IMPERIAL randomized controlled trial was an international clinical study of the Eluvia drug-eluting stent compared with the Zilver PTX drug-coated stent for treating lesions of the femoropopliteal arterial segment (i.e., arteries in the thigh).

What were the results?

Long-term follow-up data showed that treatment with Eluvia delayed lesion restenosis and extended the time before reintervention was needed.

What do the results mean?

The time patients spend without undergoing reintervention is a potentially useful parameter for healthcare stakeholders when comparing interventional options. Avoiding repeat hospitalization and invasive procedures is important to patients and such a delay could lead to cost savings depending on the surveillance period, as shown in cost-avoidance scenarios based on costs associated with reintervention episodes of care.

Supplementary Material

File (supplementary material.docx)

References

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