Routine cerebral embolic protection in transcatheter aortic valve implantation: rationale and design of the randomised British Heart Foundation PROTECT-TAVI trial

DOI: 10.4244/EIJ-D-22-00713

Rajesh Kharbanda
Rajesh K. Kharbanda1,2, PhD, FRCP; Alexander David Perkins3, MSc; James Kennedy4, FRCP; Adrian P. Banning1, FRCP; Andreas Baumbach5, MD; Daniel J Blackman6, MD, MBChB, MRCP; Matthew Dodd2, MSc; Richard Evans2, BA; David Hildick-Smith7, FRCP; Zahra Jamal2, MSc; Peter Ludman8, MD; Stephen Palmer9, PhD; Rodney Stables10, DM; Tim Clayton2, MSc
1. NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK; 2. Department of Cardiovascular Medicine, University of Oxford, Oxford, UK; 3. Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK; 4. Acute Vascular Imaging Centre, Radcliffe Department of Medicine, University of Oxford, Oxford, UK; 5. Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, UK and Barts Heart Centre, London, UK; 6. Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 7. Cardiac Surgery, Cardiac Center, Royal Sussex County Hospital, Brighton, UK and Sussex University Hospitals Trust, Brighton, UK; 8. Institute of Cardiovascular Sciences, University of Birmingham, Birmingham UK; 9. Centre for Health Economics, University of York, York, UK; 10. Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool, UK and Liverpool Heart & Chest Hospital, Liverpool, UK

Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis. Cerebral embolic protection (CEP) devices may impact periprocedural stroke by capturing debris destined for the brain. However, there is a lack of high-quality randomised trial evidence supporting the use of CEP during TAVI. The British Heart Foundation (BHF) PROTECT-TAVI trial will address whether the routine use of CEP reduces the incidence of stroke in patients undergoing TAVI. BHF PROTECT-TAVI is a prospective, open-label, outcome-adjudicated, multicentre randomised controlled trial. The trial is open to all adult patients scheduled for TAVI at participating specialist cardiac centres across the United Kingdom who are able to receive the CEP device. The trial will recruit 7,730 participants. Participants will be randomised in a 1:1 ratio to undergo TAVI with CEP or TAVI without CEP (standard of care). The primary outcome is the incidence of stroke at 72 hours post-TAVI. Key secondary outcomes include the incidence of stroke and all-cause mortality up to 12 months post-TAVI, disability and cognitive outcomes, stroke severity, access site complications and a health economics analysis. The sample size of 7,730 participants has 80% power to detect a 33% relative risk reduction from a 3% incidence of the primary outcome in the controls. Trial recruitment commenced in October 2020. As of October 2022, 3,068 patients have been enrolled. BHF PROTECT-TAVI is designed to provide definitive evidence on the clinical efficacy and cost-effectiveness of using routine CEP with the SENTINEL device to reduce stroke in TAVI.

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cerebral protectionclinical researchclinical trialstavi
Interventions for valvular diseaseTAVI
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