Summary: Background: Drug-coated balloons (DCB) reduce restenosis and reintervention in femoropopliteal peripheral artery disease (PAD), but uncertainty remains regarding benefit in terms of clinical outcomes and long-term safety. This systematic review and meta-analysis compared clinical and functional outcomes of patients receiving DCB versus plain old balloon (POBA) angioplasty. Materials and methods: Randomised trials comparing DCB versus POBA for symptomatic femoropopliteal PAD were searched in MEDLINE, Embase, and CENTRAL (inception to 14 October 2025). Studies including below-the-knee disease were excluded. Groups were compared for the incidence of major amputation, clinically driven target lesion revascularization (CD-TLR), as defined by individual trials, major adverse limb events (MALE), and all-cause death, as well as improvement in Rutherford classification, EuroQol-5, Walking-Impairment-Questionnaire, and six-minute-walking-test. Pooled risk ratios and mean differences were calculated using random-effects models. Results: We included 27 trials (4,248 patients: DCB = 2,507 of whom 2,506 treated with paclitaxel-coated balloons; POBA = 1,741). DCB significantly reduced CD-TLR (relative risk (RR) 0.53; 95% confidence interval (CI):0.44–0.64, p < .01). The proportion of patients with improvement of at least one Rutherford category was greater after DCB at 6–12 months (6 months: RR 1.11 95% CI: 1.03–1.20, p = .005, 12 months: RR 1.06 95% CI: 1.01–1.12, p = .03), but not at 24 months. We found no evidence of differences between groups for any of the other outcomes with results consistent across subgroups (DCB type, native vs. in-stent, low-risk-of-bias trials). Conclusions: Among patients with femoropopliteal PAD, paclitaxel-coated balloon angioplasty reduced CD-TLR, and improved Rutherford category compared with POBA. We did not find evidence to support the use of paclitaxel-coated balloons to reduce the risk of major amputation or MALE, whereas it did not appear to influence the risk of death at long-term follow-up.
Madaro et al. (Mon,) studied this question.