Staying up to date with landmark clinical trials is essential for evidence-based patient care, especially in fields like vascular surgery and interventional cardiology. The recently published BASIL-3 trial sheds light on the best endovascular approach for patients with chronic limb-threatening ischaemia (CLTI).
Study Overview
- Title: BASIL-3: Plain versus drug balloon and stenting in severe ischaemia of the leg
- Design: Open-label, three-arm, randomized, multicentre, phase 3 trial
- Publication: Andrew W Bradbury et al. BMJ 2025;388:e080881
Objective
To determine the most clinically effective primary endovascular revascularization strategy for patients with CLTI requiring femoro-popliteal revascularisation (with or without infra-popliteal intervention).
Participants
- Total Patients Enrolled: 481
- Inclusion Criteria: Patients with CLTI requiring femoro-popliteal, with or without infra-popliteal, endovascular revascularisation.
Interventions Compared
- Group A: Plain Balloon Angioplasty ± Bare Metal Stent (PBA±BMS) – 160 patients
- Group B: Drug-Coated Balloon Angioplasty ± BMS (DCBA±BMS) – 161 patients
- Group C: Drug-Eluting Stents (DES) – 160 patients
Primary Outcomes
Major Amputation or Death:
- PBA±BMS vs. DCBA±BMS:
- 66 events vs. 60 events
- Hazard Ratio (HR) 0.84, 97.5% CI 0.61–1.16, P=0.22
- PBA±BMS vs. DES:
- 66 events vs. 58 events
- HR 0.83, 0.60–1.15, P=0.20
Secondary Outcomes
No differences in serious adverse events were reported between the groups.
Conclusion
The BASIL-3 trial concludes that neither DCBA±BMS nor DES offered significant clinical benefit over PBA±BMS in patients undergoing endovascular femoro-popliteal revascularisation for CLTI. These findings suggest that more complex (and often costlier) drug-based interventions may not provide added value over traditional plain balloon angioplasty with or without stenting in this patient population.
Clinical Implications
For clinicians treating patients with CLTI, these results support a more conservative approach using PBA±BMS, reserving drug-based interventions for specific cases where additional benefits have been clearly demonstrated.