Comparative Outcomes of Supera Interwoven Nitinol Versus Eluvia Fluoropolymer-Based Drug-Eluting Stents for the Treatment of Severely Calcified Femoropopliteal Artery Lesions: Results of the ELDORADO Study.

Background: Supera interwoven nitinol stents (IWNS) and Eluvia fluoropolymer-based drug-eluting stents (DES) were designed to improve the patency of the femoropopliteal (FP) artery; however, which type of stent yields superior outcomes in calcified FP lesions remains unclear.

Aims: To compare the safety and efficacy of Supera IWNS and Eluvia DES in severely calcified FP lesions.

Methods: This study retrospectively analyzed 257 consecutive patients who underwent endovascular therapy using either IWNS (n = 123) or DES (n = 134) for FP lesions with peripheral arterial calcium scoring system (PACSS) grade 3 or 4 severe calcification between April 2018 and December 2021 at eight cardiovascular centers in Japan.

Results: Propensity score (PS) matching extracted 138 matched patients with no remarkable intergroup difference in patient and lesion characteristics. The 1-year primary patency rates in the matched population were not significantly different between the IWNS and DES groups (85.4% vs. 89.8%, p = 0.320). A significant interaction between the stents used and the number of below-the-knee (BTK) runoff vessels was observed (interaction p = 0.048). The hazard ratio for restenosis was 2.68 (95% confidence interval, 0.51-14.2) in the group with no BTK runoff, favoring DES.

Conclusion: In PS-matched patients with severely calcified FP lesions, 1-year primary patency was not significantly different between treatments using Supera IWNS and Eluvia DES.