Drug Balloon and Stenting Do Not Confer Patient Benefit versus Plain Balloon in Limb-Threatening Ischemia

Bradbury AW, Hall JA, Popplewell MA, et al. Plain versus Drug Balloon and Stenting in Severe Ischaemia of the Leg (BASIL-3): Open Label, Three Arm, Randomised, Multicentre, Phase 3 Trial. BMJ. 2025;388:e080881.

Randomized trials have supported the use of surgical revascularization for patients with chronic limb-threatening ischemia when femoral-popliteal bypass is needed and adequate vein for the bypass conduit is available.

When endovascular revascularization is required because of inadequate vein availability, high patient risk, or patient preference, data to support the choice of endovascular device—plain balloon with or without bare metal stenting (PBA±BMS), drug coated balloon with or without bare metal stenting (DCBA±BMS), or drug-eluting stenting (DES)—are lacking.

This randomized trial (n = 481) compared the three treatment options; the main outcome of interest was amputation-free survival.

Over a 5-year follow up interval, death or amputation occurred in 66% of the PBA±BMS group, 60% of the DCBA±BMS group, and 58% of the DES group. The authors concluded that neither DCBA±BMS nor DES conferred significant patient benefit compared with PBA±BMS.