Trial reportBMJ (Clinical research ed.)2025
Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial.
Trial report in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed.
- Plain balloon angioplasty +/- bare metal stenting versus drug-coated balloon angioplasty +/- bare metal stenting versus primary drug-eluting stenting in patients with chronic limb-threatening ischaemia: BASIL-3, an open-label, three-arm, randomised, multi-centre, phase 3 trial.Health technology assessment (Winchester, England) · 2026Trial
- Long-term mortality rate and clinical outcomes associated with femoro-popliteal drug-coated balloon angioplasty and drug-eluting stents in chronic limb-threatening ischaemia: an analysis of the BASIL-3 RCT.The British journal of surgery · 2025Trial
- Reproducibility of Published Randomized Controlled Trial Results in Cardiovascular Surgery: Protocol for a Meta-Epidemiological Umbrella Review.JMIR research protocols · 2026Article
- Biomimetic injectable engineered hierarchical porous microspheres for enhanced synergistic cell therapy of critical limb ischemia.Bioactive materials · 2026Article
- Paclitaxel Efficacy in Dialysis-Dependent Peripheral Artery Disease: A National Cohort Analysis.Journal of the American Heart Association · 2026Article
- Patient and public involvement in pragmatic trials with older adults: a multi-methods study of researchers' experiences.BMC geriatrics · 2026Article
- Clinical outcomes of directional atherectomy versus plain balloon angioplasty as vessel preparation prior to drug-coated balloon treatment for femoropopliteal occlusive disease.Scientific reports · 2026Observational
- Article
- Outcomes of lower extremity revascularization for chronic limb-threatening ischemia in diabetic and non-diabetic patients: a comparative study.Annals of medicine and surgery (2012) · 2026Article
- Unveiling the Sex-Based Divide: Exploring Sex Differences in Peripheral Artery Disease.Current atherosclerosis reports · 2025Review
- Practical guidelines for the prevention and management of diabetic foot disease in China.Burns & trauma · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine which primary endovascular revascularisation strategy represents the most clinically effective treatment for patients with chronic limb threatening ischaemia who require endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.
designThree arm, open label, pragmatic, multicentre, randomised, phase 3 superiority trial (BASIL-3).
setting35 UK NHS vascular units.
participantsPatients with chronic limb threatening ischaemia who required endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.
interventionsParticipants were randomly assigned (1:1:1) to femoro-popliteal plain balloon angioplasty with or without bare metal stenting (PBA±BMS), drug coated balloon angioplasty with or without bare metal stenting (DCBA±BMS), or drug eluting stenting (DES) as their first revascularisation strategy.
main outcome measuresThe primary outcome was amputation free survival defined as time to first major amputation or death from any cause. Secondary outcomes included the composite components of the primary outcome, major adverse limb events, major adverse cardiac events, and other prespecified clinical and patient reported outcome measures. Serious adverse events were collected up to 30 days after the first revascularisation procedure.
resultsBetween 29 January 2016 and 31 August 2021, 481 participants were randomised (167 (35%) women, mean age 71.8 years (standard deviation 10.8)). Major amputation or death occurred in 106 of 160 (66%) participants in the PBA±BMS group, 97 of 161 (60%) in the DCBA±BMS group, and 93 of 159 (58%) in the DES group (adjusted hazard ratios: PBA±BMS
conclusionsNeither DCBA±BMS nor DES conferred significant clinical benefit over PBA±BMS in the femoro-popliteal segment in patients with chronic limb threatening ischaemia undergoing endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.
trial registrationISRCTN registry ISRCTN14469736.
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