Evidence and Guideline Recommendations for Drug‑Coated Balloons in Peripheral Artery Disease

Efficacy Evidence

Meta‑analysis of femoropopliteal lesions shows that drug‑coated balloons significantly reduce restenosis rates, and higher paclitaxel loads (3.0 mg/mm² vs 2.0 mg/mm²) provide greater restenosis reduction. This finding is based on pooled randomized trials. 1
Recent analyses refute the earlier mortality signal associated with paclitaxel‑coated devices, indicating no confirmed increase in long‑term mortality after drug‑coated balloon use. 1

The U.S. FDA issued a warning (January 2019) about a possible increased long‑term mortality risk with paclitaxel‑coated peripheral devices, prompting heightened surveillance of these products. 2

The Canadian Cardiovascular Society (2022) recommends drug‑coated balloons for SFA disease, citing randomized trial data and meta‑analysis that demonstrate a significant reduction in restenosis compared with plain balloon angioplasty. (Class IIa, Level A evidence). 1
The European Society of Cardiology (ESC) Guidelines (2024) state that for short infrapopliteal lesions extending into the SFA, drug‑eluting balloons and bare‑metal stents have no superiority over plain balloon angioplasty. (Evidence level: moderate). 3
The ACC/AHA Guidelines (2024) list drug‑coated balloon angioplasty as a standard endovascular option for peripheral revascularization, alongside other modalities. (Class I, Level B). 4

The ESC Guidelines (2024) conclude that drug‑eluting balloons and bare‑metal stents do not outperform plain balloon angioplasty for infrapopliteal disease; drug‑eluting stents may be considered only for short proximal tibial lesions. (Evidence level: moderate). 3
The Canadian Guidelines (2022) note that infrapopliteal endovascular therapy is characterized by high restenosis rates (primary patency 22 %–92 % at 1 year), yet acceptable limb‑salvage outcomes can be achieved despite limited vessel patency. (Evidence level: moderate). 1

Patency vs. limb salvage in tibial disease: Angiographic patency improvements with drug‑coated balloons do not necessarily translate into better limb‑salvage or mortality outcomes; therefore, the additional cost of DCBs may not be justified in this vascular bed. (Based on guideline commentary). 1