Application of Drug-Eluting Stent With Drug-Coated Balloon Strategy for the Endovascular Treatment of Long-Segment Femoropopliteal Artery Disease.

Abstract

Purpose: Endovascular therapy (EVT) has emerged as a primary approach for managing femoropopliteal artery (FPA) lesions, leveraging drug-eluting stents (DESs), and drug-coated balloons (DCBs), to enhance clinical outcomes. Although a full DES coverage strategy is effective in treating complex lesions, concerns over long-term complications prompt the exploration of alternative strategies. The aim of this study was to investigate clinical result of combination therapy of DES with DCB and compare them with full DES implantation.

Materials and methods: This retrospective, single-center study analyzed 131 patients with occlusive FPA lesions treated at our institution between 2019 and 2022. Patients with Rutherford classification stages 2 to 5 who underwent successful EVT were included. The study compared the outcomes of the drug-within-drug (DWD) strategy, ie, combining DES for failed vessel preparation segments and DCB for successful ones, with those of full DES implantation. The primary outcomes were the primary patency rates, and the secondary outcomes included clinically-driven target lesion revascularization (CD-TLR) rates, restenosis patterns, and survival outcomes.

Results: Of the 131 patients initially considered, 118 met the inclusion criteria, with 45 in the DWD group and 73 in the full metal jacket (FMJ) stent group. The DWD group demonstrated equivalent 1-year primary patency rates (85.3%) to the FMJ group (87.9%, p=0.239). Similarly, no significant differences in CD-TLR rates were found between the 2 groups. The restenosis patterns and subsequent treatment strategies were not significantly different.

Conclusion: The DWD strategy offers a viable alternative to full DES coverage in treating long-segment FPA lesions, with comparable restenosis and target lesion revascularization (TLR) rates. This approach may mitigate risks associated with full-length stenting, such as thrombosis, and challenges in repeat revascularizations by tailoring treatment to lesion characteristics. The DWD strategy represents a promising approach for complex FPA lesions, providing a balanced solution that potentially reduces long-term complications while maintaining effective patency and revascularization rates.

Clinical impact: The efficacy of drug-eluting stents (DES) in treating femoropopliteal artery (FPA) lesions has been well demonstrated. However, concerns remain regarding complications such as thrombotic occlusion and aneurysmal degeneration, especially when full stemt coverage of whole lesions is performed. The "Drug-with-Drug" (DWD) strategy, which involves implanting DES only at sites with severe dissection or residual stenosis after pre-balloon dilation and using drug coated balloons (DCB) for segments successfully prepared without stenting, has shown comparable outcomes to full stent coverage. Unlike traditional bailout stenting or spot stenting, the DWD approach maximizes the benefits of drug technology and presents a valuable option for treating long-segment FPA lesions.