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Clinical Trial
. 2025 Feb 24:388:e080881.
doi: 10.1136/bmj-2024-080881.

Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial

Andrew W Bradbury  1 , Jack A Hall  2 , Matthew A Popplewell  3   4 , Lewis Meecham  5 , Gareth R Bate  6 , Lisa Kelly  6 , Jon J Deeks  2   4   7 , Catherine A Moakes  2 ; BASIL-3 Investigators
Collaborators, Affiliations
Clinical Trial

Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial

Andrew W Bradbury et al. BMJ. .

Abstract

Objective: To 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.

Design: Three arm, open label, pragmatic, multicentre, randomised, phase 3 superiority trial (BASIL-3).

Setting: 35 UK NHS vascular units.

Participants: Patients with chronic limb threatening ischaemia who required endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.

Interventions: Participants 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 measures: The 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.

Results: Between 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 v DCBA±BMS: 0.84, 97.5% confidence interval 0.61 to 1.16, P=0.22; PBA±BMS v DES: 0.83, 0.60 to 1.15, P=0.20). No differences in serious adverse events were reported between the groups.

Conclusions: Neither 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 registration: ISRCTN registry ISRCTN14469736.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from UK National Institute for Health and Care Research for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

Fig 1
Fig 1
Consolidated standards of reporting trials (CONSORT) diagram. Assessment conducted refers to clinical review, not assessment of primary endpoint
Fig 2
Fig 2
Amputation free survival (AFS) Kaplan-Meier plot and hazard ratio over time fitted assuming non-proportional hazards (intention-to-treat analysis). CI=confidence interval
See this image and copyright information in PMC

References

    1. Conte MS, Bradbury AW, Kolh P, et al. GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS) . Global vascular guidelines on the management of chronic limb-threatening ischemia. Eur J Vasc Endovasc Surg 2019;58(1S):S1-109, 109.e33. 10.1016/j.ejvs.2019.05.006 - DOI - PMC - PubMed
    1. Bradbury AW, Adam DJ, Bell J, et al. . Multicentre randomised controlled trial of the clinical and cost-effectiveness of a bypass-surgery-first versus a balloon-angioplasty-first revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial. Health Technol Assess 2010;14:1-210, iii-iv. 10.3310/hta14140 - DOI - PubMed
    1. Farber A, Menard MT, Conte MS, et al. BEST-CLI Investigators . Surgery or endovascular therapy for chronic limb-threatening ischemia. N Engl J Med 2022;387:2305-16. 10.1056/NEJMoa2207899 - DOI - PubMed
    1. Bradbury AW, Moakes CA, Popplewell M, et al. BASIL-2 Investigators . A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial. Lancet 2023;401:1798-809. 10.1016/S0140-6736(23)00462-2. - DOI - PubMed
    1. Almasri J, Adusumalli J, Asi N, et al. . A systematic review and meta-analysis of revascularization outcomes of infrainguinal chronic limb-threatening ischemia. J Vasc Surg 2019;69(6S):126S-36S. 10.1016/j.jvs.2018.01.071 - DOI - PubMed

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