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BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial
Benjamin D Hunt1, Matthew A Popplewell2, Huw Davies2
1Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, Public Health Building, University of Birmingham, Birmingham, B15 2TT, UK. b.hunt@bham.ac.uk.
Insights
The BASIL-3 trial evaluates new endovascular treatments for severe limb ischaemia (SLI). It compares drug-eluting stents and drug-coated balloons against standard angioplasty to determine clinical and cost-effectiveness for NHS funding.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Health Economics
Background:
- Severe limb ischaemia (SLI) involves rest pain or tissue loss due to atherosclerotic peripheral arterial disease.
- Superficial femoral and popliteal arteries are commonly affected and treated with endovascular techniques.
- The clinical benefit and cost-effectiveness of drug-eluting stents (DES) and drug-coated balloons (DCB) versus traditional methods are unknown.
Purpose of the Study:
- To compare the clinical and cost-effectiveness of plain balloon angioplasty, DCB angioplasty, and primary stenting with DES for SLI.
- To assess amputation-free survival and quality-adjusted life years.
- To inform National Health Service (NHS) funding decisions for advanced endovascular treatments.
Main Methods:
- BASIL-3 is a multicentre, randomised controlled trial (RCT) in the UK.
- Compares plain balloon angioplasty +/- bare metal stenting, DCB angioplasty +/- bare metal stenting, and primary DES stenting.
- Primary outcome: amputation-free survival; economic outcome: cost per quality-adjusted life year.
Main Results:
- N/A - Results not yet available as per abstract.
- The trial aims to recruit 861 participants over 3 years with 2-5 years follow-up.
- The study is designed as a pragmatic RCT reflecting current UK clinical practice.
Conclusions:
- The BASIL-3 trial will provide crucial data on the effectiveness and economic value of DES and DCB for SLI.
- Results will guide NHS commissioning and clinical practice for femoro-popliteal interventions.
- This research addresses a significant gap in knowledge regarding advanced endovascular treatment options.
Background:
Severe limb ischaemia (SLI) is defined as the presence of rest pain and/or tissue loss secondary to lower extremity atherosclerotic peripheral arterial disease. The superficial femoral and popliteal arteries are the most commonly diseased vessels in such patients and are being increasingly treated using endovascular revascularisation techniques. However, it is currently unknown whether drug-eluting stents and drug-coated balloons confer additional clinical benefits over more established techniques using plain balloons and bare metal stents, or whether they represent a cost-effective use of NHS resources.
Methods:
The BASIL-3 trial is a UK National Institute for Health Research, Health Technology Assessment Programme-funded, multicentre, randomised controlled trial (RCT) comparing the clinical and cost-effectiveness of plain balloon angioplasty with or without bail-out bare metal stenting, drug-coated balloon angioplasty with or without bail-out bare metal stenting, and primary stenting with drug-eluting stents for SLI secondary to femoro-popliteal disease. Patients with 'multilevel' disease may receive aorto-iliac and/or infrapopliteal treatments concurrently with their randomised femoro-popliteal intervention. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the index limb or death from any cause. The primary outcome for the economic analysis is cost per quality-adjusted life year. Secondary outcome measures include overall survival, major adverse limb events, major adverse cardiac events, relief of ischaemic pain, healing of tissue loss, and quality of life. The required sample size has been calculated at 861 participants (287 on each arm). These patients will be recruited over 3 years and followed-up for between 2 and 5 years.
Discussion:
BASIL-3 is a pragmatic RCT designed to reflect current UK clinical practice. The results will inform decision-making regarding the appropriateness of funding the use of drug-coated balloons and drug-eluting stents, by the NHS, for the management of SLI due to femoro-popliteal disease.
Trial Registration:
ISRCTN Registry, identifier: ISRCTN14469736 . Registered on 22 October 2015.
