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.