Emerging Sirolimus-Based Drug-Coated Technologies for Femoropopliteal Disease: A Systematic Review

Sirolimus-coated devices offer a promising alternative to paclitaxel-based technologies for femoropopliteal PAD, with encouraging efficacy and a favorable short- to mid-term safety profile. Outcomes are comparable to those of paclitaxel devices, even in complex lesions. Nevertheless, current evidence is limited by heterogeneous study designs, small sample sizes, and relatively short follow-up. Larger randomized trials with independent adjudication and extended surveillance are required to define the long-term safety and clinical role of sirolimus in femoropopliteal interventions.Clinical ImpactThis systematic review consolidates the emerging clinical evidence on sirolimus-coated technologies for femoropopliteal disease, offering clinicians a structured appraisal of efficacy and safety across devices and lesion complexities. In the context of persistent debate surrounding paclitaxel, sirolimus represents a mechanistically distinct, cytostatic alternative with encouraging short- and mid-term outcomes and no current safety signal. For practicing interventionists, these findings support the cautious integration of sirolimus-coated balloons and newer-generation stents into daily practice, particularly in complex lesions. The innovation lies in controlled drug delivery platforms leveraging mTOR inhibition, potentially combining antiproliferative efficacy with improved vascular healing. Larger randomized trials will determine their definitive role in treatment algorithms.