Does a procedure to open blood vessels (balloon
www.cochrane.org
Aug. 15, 2026, 4:26 a.m.
Peripheral arterial disease, a condition characterized by reduced blood supply to the lower legs due to arterial blockages, affects numerous individuals and can result in serious complications including pain, infection, and amputation. While initial treatment typically involves medication and lifestyle modifications such as smoking cessation and exercise programs, some patients require surgical intervention. Drug-eluting balloon angioplasty, which coats blood vessels with chemotherapy agents like paclitaxel during the procedure, has emerged as a promising alternative to traditional plain balloon angioplasty. A comprehensive review analyzing 31 randomized clinical trials involving 5,292 participants compared these two approaches for treating lower leg peripheral arterial disease in both thigh and leg arteries above and below the knee. The analysis revealed that drug-eluting balloons demonstrated superior outcomes in reducing the need for repeat treatments on the same artery, preventing restenosis, and minimizing late lumen loss. However, no significant differences were observed between the two techniques regarding amputation rates, amputation-free survival, mortality, ankle-brachial index changes, quality of life scores, or walking ability. These findings suggest that while drug-eluting balloons offer technical advantages in preventing vessel renarrowing, they do not translate into meaningful improvements in patient-centered outcomes.