Comparative Effectiveness of Peripheral Angioplasty Strategies for 1-Year Restenosis in Lower Limb Artery Disease: A Retrospective Single-Center Analysis

Background: Optimal endovascular strategy for lower limb peripheral artery disease (PAD) remains debated, particularly regarding 1-year restenosis. Aim: To evaluate the association between drug-coated balloon (DCB)-based angioplasty and 1-year restenosis compared with stent-based and plain balloon strategies in a real-world PAD cohort. Methods: We performed a single-center retrospective analysis of 283 consecutive patients (mean age 67.5 ± 11.2 years, 79% male) undergoing lower limb angioplasty between 2010 and 2023. Patients were treated with one of five strategies: direct stent, pre-dilatation + stent, stent + post-dilatation, DCB ± bailout stent, or plain old balloon angioplasty (POBA). Restenosis at 12 months (≥50% diameter reduction on Doppler, CT angiography, or angiography) was the primary endpoint. Kaplan-Meier curves and multivariable Cox regression adjusted for clinical and lesion characteristics were used. The prespecified main comparison was DCB ± stent versus non-DCB strategies. Results: Overall, 1-year restenosis occurred in 81 patients (28.7%). Restenosis rates were 15.4% with DCB ± stent versus 34.2%, 29.8%, 31.5%, and 38.1% with direct stent, pre-dilatation + stent, stent + post-dilatation, and POBA, respectively (p = 0.004). In adjusted analysis, DCB ± stent was associated with a lower hazard of restenosis compared with direct stent (HR 0.52; 95% CI 0.31–0.87), whereas POBA was associated with a higher hazard versus DCB ± stent (HR 1.89; 95% CI 1.01–3.53). Periprocedural complication rates were low and similar across groups (overall 6.3%). Conclusions: In this real-world PAD cohort, DCB-based angioplasty was independently associated with lower 1-year restenosis compared with stent-based and plain balloon strategies, without an excess of procedural complications. Given the observational design and lesion-driven strategy selection, these findings should be interpreted as hypothesis-generating but support broader use of DCB in appropriately selected lesions.