BASIL-3 Study on Course to Resume Recruitment in September

 

August 9, 2019—The Vascular Society of Great Britain and Ireland announced that the BASIL-3 trial is on course to resume recruitment in September 2019.

The society advised that this plan is supported by recommendations from the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), due process involving the National Institute for Health Research's Health Technology Assessment (NIHR HTA), and consultation with all of the stakeholders over the last few months.

BASIL-3 is a multicenter, randomized controlled trial of the clinical efficacy and cost-effectiveness of drug-coated balloons, drug-eluting stents, and plain balloon angioplasty with bailout bare-metal stent revascularization strategies for severe limb ischemia caused by atherosclerotic femoropopliteal (with or without infrapopliteal involvement) peripheral artery disease. The clinical trial is being directed by the Birmingham Clinical Trials Unit (BCTU) at the University of Birmingham's College of Medical and Dental Sciences in Birmingham, United Kingdom.

In December 2018, recruitment in the trial was paused in response to the publication of findings from a systematic review and meta‐analysis of randomized controlled trials evaluating paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries by Konstantinos Katsanos, MD, et al in Journal of the American Heart Association.

In June, BCTU issued a statement explaining that plans to resume the trial would be underway after the MHRA's Expert Advisory Group recommended that trials such as BASIL-3 should consider resuming recruitment. In these recommendations, MHRA also issued noted that the use of paclitaxel devices should still be considered for the treatment of chronic limb-threatening ischemia in accordance with the National Institute for Health and Care Excellence's guidance document.

The society advised that there is aggregate data on 411 patients who had been randomized before recruitment was paused in December 2018. Statisticians have estimated that to maintain 90% power and a minimum of 2-year follow-up (as per the original protocol), a total enrollment of approximately 500 patients will be needed to answer the original question of the study. In addition, in concordance with advice from MHRA and FDA, the society is discussing with NIHR HTA and other stakeholders, the possibility of extending follow-up to a minimum of 5 years to examine late mortality.

To see all of the articles in our continuing coverage of the paclitaxel safety data review, please visit this page.

 

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