Background:

Paclitaxel-based devices improve femoropopliteal outcomes; however, the optimal strategy for de novo lesions by lesion complexity remains uncertain. This study compared long-term outcomes of full-coverage drug-eluting stent (DES) implantation and drug-coated balloon (DCB) angioplasty stratified by the Trans-Atlantic Inter-Society Consensus II (TASC II) classification.

Methods:

This retrospective, single-center study included 419 patients (507 limbs) with de novo femoropopliteal lesions treated between 2019 and 2021. Limbs were stratified into TASC II A/B (186 limbs) and C/D (321 limbs) groups and treated with DES (107 limbs) or DCB (400 limbs). The primary endpoint was 3-year primary patency, defined as freedom from target lesion revascularization (TLR) or duplex ultrasound-detected restenosis (peak systolic velocity ratio ≥2.5). Secondary endpoints included 3-year freedom from TLR and amputation-free survival (AFS).

Results:

In TASC II A/B lesions, 3-year primary patency was comparable between DES and DCB (80.0% vs 76.9%, p=0.432), as were freedom from TLR (84.2% vs. 88.0%, p=0.959) and AFS (74.3% vs 78.3%, p=0.834). In TASC II C/D lesions, DES achieved higher 3-year primary patency (85.1% vs 50.3%, p<0.001) and freedom from TLR (90.2% vs 66.7%, p=0.008) than DCB, while AFS did not differ significantly (90.2% vs 66.7%, p=0.074). Within the DCB cohort, 3-year primary patency was lower for C/D than A/B lesions (50.3% vs 76.9%, p<0.001), whereas DES outcomes were consistent across strata (85.1% vs 80.0%, p=0.828). The AFS was comparable between the 2 strategies across both TASC II strata. Regarding restenosis patterns, 3-year reocclusion rates were similar in A/B (DES 20% vs DCB 15%, p=0.544), whereas they were higher with DES in C/D (60% vs 29%, p=0.044). On multivariable analysis, below-the-knee runoff ≤1 (hazard ratio [HR]=1.96) and TASC II D classification (HR=2.57) were independent predictors of restenosis in DCB-treated C/D lesions, whereas ischemic wounds (HR=6.61) and extensive eccentric calcification (HR=14.3) predicted restenosis in DES-treated A/B lesions.

Conclusion:

Full-coverage DCB and DES yielded favorable outcomes in TASC II A/B lesions, supporting a stentless strategy in selected cases. For TASC II C/D lesions, DES provided superior long-term patency and lower reintervention rates, highlighting the importance of lesion complexity-based device selection.

Clinical Impact

This study demonstrates that lesion complexity, as defined by the TASC II classification, is a decisive factor in device selection for femoropopliteal interventions. In de novo TASC II A/B lesions, full-coverage drug-coated balloon angioplasty and drug-eluting stent implantation achieved comparable 3-year outcomes, supporting a stentless approach in suitable cases. In contrast, the drug-eluting stent strategy provided superior long-term patency in complex TASC II C/D lesions, emphasizing the value of full-lesion coverage and optimized lumen expansion. These findings offer lesion-specific guidance that may refine treatment algorithms, improve durability of revascularization, and support individualized therapy in peripheral artery disease.

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