BASIL-3 (DCBA vs. PBA)
Trial question
What is the role of drug-coated balloon angioplasty with or without bare-metal stenting in patients with chronic limb-threatening ischemia who required endovascular femoropopliteal revascularization, with or without infrapopliteal revascularization?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 321
321 patients (112 female, 209 male).
Inclusion criteria: patients with chronic limb-threatening ischemia who required endovascular femoropopliteal revascularization, with or without infrapopliteal revascularization.
Key exclusion criteria: life expectancy < 6 months; intervention to the target femoropopliteal vessel within the past 12 months; intermittent claudication.
Interventions
N=161 DCBA with or without BMS (drug-coated balloon angioplasty with or without bare-metal stenting as first revascularization strategy).
N=160 PBA with or without BMS (femoropopliteal plain balloon angioplasty with or without bare-metal stenting as first revascularization strategy).
Primary outcome
Amputation-free survival
60%
66%
66.0 %
49.5 %
33.0 %
16.5 %
0.0 %
DCBA with or without
BMS
PBA with or without
BMS
No significant
difference ↔
No significant difference in amputation-free survival (60% vs. 66%; HR 0.84, 97.5% CI 0.61 to 1.16).
Secondary outcomes
No significant difference in death from any cause (56% vs. 60%; HR 0.86, 97.5% CI 0.62 to 1.2).
No significant difference in major amputation (11% vs. 14%; CSHR 0.74, 97.5% CI 0.36 to 1.5).
No significant difference in major adverse limb events (35% vs. 37%; RR 0.92, 97.5% CI 0.66 to 1.28).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with chronic limb-threatening ischemia who required endovascular femoropopliteal revascularization, with or without infrapopliteal revascularization, DCBA with or without BMS was not superior to PBA with or without BMS with respect to a amputation-free survival.
Reference
Andrew W Bradbury, Jack A Hall, Matthew A Popplewell 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 Feb 24:388:e080881.
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