{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T09:53:44Z","timestamp":1793267624519,"version":"4.5.0"},"reference-count":70,"publisher":"Hogrefe Publishing Group","license":[{"start":{"date-parts":[[2026,4,27]],"date-time":"2026-04-27T00:00:00Z","timestamp":1777248000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vasa"],"abstract":"<jats:p>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\u20130.64, p &lt; .01). The proportion of patients with improvement of at least one Rutherford category was greater after DCB at 6\u201312 months (6 months: RR 1.11 [95% CI: 1.03\u20131.20], p = .005, 12 months: RR 1.06 [95% CI: 1.01\u20131.12], 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.<\/jats:p>","DOI":"10.1024\/0301-1526\/a001283","type":"journal-article","created":{"date-parts":[[2026,4,27]],"date-time":"2026-04-27T16:03:10Z","timestamp":1777305790000},"source":"Crossref","is-referenced-by-count":3,"title":["Clinical and patient-reported outcomes after drug-coated balloon angioplasty for femoropopliteal peripheral artery disease"],"prefix":"10.1024","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0049-3522","authenticated-orcid":true,"given":"Benedetta","family":"Madaro","sequence":"first","affiliation":[{"name":"Department of Vascular Medicine, University Hospital Zurich, Zurich, Switzerland"},{"name":"Internal Medicine Residency Program, School of Medicine, University of Insubria, Varese and Como, 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