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.