CVIR Endovasc. 2026 Jul 30;9(1):93. doi: 10.1186/s42155-026-00744-1.
ABSTRACT
BACKGROUND: A drug-coated balloon (DCB)-based "leave-nothing-behind" strategy has become a predominant approach for femoropopliteal artery (FPA) lesions in contemporary clinical practice. However, despite the intention to complete procedures with DCB alone, stent implantation is frequently required because of severe dissection, elastic recoil, or suboptimal lesion preparation. Whether DCB angioplasty combined with selective stent implantation compromises 1-year primary patency compared with DCB monotherapy remains uncertain.
METHODS: In this prospective multicenter registry, 310 limbs in 277 patients undergoing endovascular therapy for FPA lesions between September 2021 and December 2022 were enrolled. Thirty-seven limbs were excluded if they had isolated common femoral artery lesions (n = 8), were treated with bare nitinol stents or stent grafts (n = 25), or were treated with plain old balloon angioplasty alone (n = 4). A total of 273 limbs in 254 cases were included in the primary outcome analysis. Patients were categorized into three groups: the DCB group (balloon angioplasty with DCB alone), the drug-eluting stent (DES) group (implantation of Eluvia™ or Zilver PTX™), and the Combination group (DCB angioplasty combined with DES). The primary endpoint was 1-year primary patency. Secondary endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinically driven target vessel revascularization (CD-TVR), which were assessed using Kaplan-Meier analysis. Factors associated with loss of primary patency were evaluated using Cox regression analysis.
RESULTS: DCB monotherapy was performed in 78.3% of cases, DESs in 10.9%, and combination therapy in 10.6%. The overall 1-year primary patency rate was 84.0%, with no significant differences among strategies (DCB: 84.1%, DES: 84.6%, Combination: 82.8%; log-rank p value = 0.91). Freedom from CD-TLR and CD-TVR at 1 year was 88.7% and 93.8%, respectively. Chronic limb-threatening ischemia and history of revascularization were independently associated with loss of primary patency. Combination therapy was not associated with an increased risk of loss of primary patency.
CONCLUSION: A DCB-based strategy with selective scaffolding may achieve acceptable patency outcomes.
PMID:42530849 | DOI:10.1186/s42155-026-00744-1