Randomized trial evaluates high-dose drug-coated balloons, improving patency rates in femoropopliteal disease, suggesting a promising alternative.
Background: Randomized trials for treating chronic limb-threatening ischemia have highlighted the effectiveness of bare-metal stents in femoropopliteal disease, despite their low long-term patency rates. This article seeks to explore the optimal outcomes of high-dose drug-coated balloons (HD-DCB) as an alternative to metal stents, offering improved patency rates and reduced intimal hyperplasia. Methods: A retrospective observational study was done with 72 femoropopliteal lesions treated with HD-DCB to collect data over an average of 2 years. The endpoints evaluated included primary patency, late lumen loss (LLL) at 6 months, and all-cause mortality at 12 months. Results: Technical success was achieved in 100% of cases. The average lesion length was 107.1 ± 42 mm. The overall primary patency rate was 75% at 1 year, with a statistically significant difference between de novo lesions (83.8%) and repeat lesions (65.7%), yielding a P = 0.029. The mean LLL was 0.45 mm, ranging from 0.07-0.51 mm. The ankle–brachial index improved from 0.343 ± 0.106 to 0.873 ± 0.073 ( P < 0.0001). The survival rate was 94.8%. Conclusions: These findings suggest that HD-DCBs are both safe and effective, providing a metal-free alternative for treating femoropopliteal artery disease. Further research is needed to confirm these results.
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Mahmoud et al. (2026) studied this question.
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