Drug-Coated Balloon Versus Plain Old Balloon Angioplasty in Isolated Popliteal and/or Superficial Femoral Artery Disease: A Retrospective Single-Center Comparative Cohort Study

Background/Objectives: Drug-coated balloons (DCBs) deliver paclitaxel to the vessel wall and leave nothing behind, which makes them mechanistically appealing here, yet head-to-head data confined to the isolated popliteal/SFA segment are still scarce. We directly compared 12-month hemodynamic, symptomatic, and patency loss outcomes between DCB and plain old balloon angioplasty (POBA) in this anatomical setting. Methods: We retrospectively reviewed 401 consecutive endovascular procedures performed at a single center between January 2021 and December 2024 for isolated popliteal and/or SFA disease, comprising 179 DCB and 222 POBA cases. 12-month endpoints of composite clinical success, asymptomatic recovery, and composite patency loss were analyzed. The composite patency loss endpoint was further fitted to a multivariable logistic regression with baseline ABI, baseline Rutherford category, lesion length, and total occlusion as covariates. The composite patency loss endpoint was further fitted to a multivariable logistic regression with baseline ABI, baseline Rutherford category, lesion length, and total occlusion as covariates, designated as the principal effect estimate. Kaplan–Meier cumulative incidence plots are presented descriptively only. Results: The study population comprised 401 patients (mean age 68.4 ± 10.6 years; 316 male [78.8%]), with 179 in the DCB arm (mean age 65.3 ± 10.5 years; 80.4% male) and 222 in the POBA arm (mean age 71.0 ± 9.8 years; 77.4% male). DCB-treated lesions started out more advanced: longer (94.5 ± 48.2 vs. 82.7 ± 43.3 mm; p = 0.010), more often totally occluded (39.7% vs. 19.4%; p < 0.001), and weighted toward TASC II C/D (p < 0.001). Mean ABI improved by +0.27 in both arms, with no detectable between-arm difference (p = 0.860; within-arm p < 0.001 in each). Asymptomatic recovery at 12 months was more common after DCB (62.0% vs. 51.4%; p = 0.033; OR 1.55, 95% CI 1.04–2.31), and composite patency loss was roughly halved (6.7% vs. 12.6%; p = 0.050; OR 0.50, 95% CI 0.25–1.01). Documented TLR (4.5% vs. 7.2%; p = 0.251) and composite clinical success (86.6% vs. 82.4%; p = 0.255) did not reach significance. Conclusions: Across 401 real-world procedures in isolated popliteal and/or SFA disease, mean ABI gain was identical between arms, yet DCB delivered measurably more complete symptomatic recovery and a near-significant halving of composite patency loss at 12 months, with both signals robust to multivariable adjustment. In this real-world setting, DCB was associated with more complete symptomatic recovery and a numerically lower composite patency loss rate; these findings are hypothesis-generating and require confirmation in adequately powered randomized trials.