Eluvia stent in endovascular treatment of femoropopliteal occlusive disease: Early results of the challenge study

Abstract

Objectives

The aim of this study was to evaluate the one-year results of the Eluvia drug-eluting vascular stent (Boston Scientific, Marlborough, MA, USA) for the treatment of femoropopliteal occlusive disease (FPOD).

Methods

From January 2021 to November 2023, this multicenter study prospectively enrolled patients with peripheral artery disease involving the femoropopliteal artery. The primary outcome measures were the rate of freedom from clinically driven target limb revascularization (f-CD-TLR), rate of freedom from major adverse events (f-MAE), rate of freedom from symptom recurrence (f-SR) and rate of freedom from all-cause death (f-ACD). The secondary outcome measures were the Rutherford grade and Vascular Quality of Life (VascuQoL) scale scores.

Results

In total, 159 patients were enrolled in this study. The mean follow-up time was 370 days, and the follow-up rate was 83.0%. The patients’ mean age was 72 years, and 82.4% were male. A total of 159 patients received 199 stent deployments. The mean lesion length was 194.4 ± 118.9 mm, and 76.7% had total occlusions. The technical success rate for endovascular treatment was 100%, and five complications occurred during the perioperative period. At one, three, six, and 12 months, the f-CD-TLR rate was 99.3%, 97.9%, 96.4%, and 92.8%, respectively; the f-MAE rate was 98.0%, 96.7%, 93.1%, and 91.3%, respectively; the f-SR rate was 94.6%, 85.5%, 80.3%, and 73.4%, respectively; and the f-ACD rate was 98.0%, 98.0%, 95.9% and 94.1%, respectively. There was a substantial increase in the Rutherford grade and average VascuQoL scores at the one-, three-, six-, and 12-month follow-ups (p < .001).

Conclusions

The Eluvia stent had a favorable effect on FPOD throughout 12 months of follow-up. Further studies with larger sample sizes and longer-term follow-up are required to confirm the real-world performance of the Eluvia stent.