Polymer-based Drug-Eluting Stent Treatment Extends the Time to Reintervention for Patients with Symptomatic Femoropopliteal Artery Disease: Clinical Evidence and Potential Economic Value.

Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymerbased 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 polymercoated 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 followand mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus Plain language summary: What is this article about?:The IMPERIAL randomized controlled trial was aninternational clinical study of the Eluvia drug-eluting stent compared with the Zilver PTX drug-coatedstent 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 lesionrestenosis and extended the time before reintervention was needed.What do the results mean?:The time patients spend without undergoing reintervention is a potentiallyuseful parameter for healthcare stakeholders when comparing interventional options. Avoiding repeathospitalization and invasive procedures is important to patients and such a delay could lead to cost savingsdepending on the surveillance period, as shown in cost-avoidance scenarios based on costs associated withreintervention episodes of care.Shareable abstract:Long-term follow-up data from the randomized IMPERIAL trial showed thattreatment with the Eluvia drug-eluting stent delayed lesion restenosis and extended the time beforereintervention 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