Routine cerebral embolic protection in transcatheter aortic valve implantation: rationale and design of the randomised British Heart Foundation PROTECT-TAVI trial
Why the study?
There is a lack of high-quality randomised trial evidence supporting the routine use of cerebral embolic protection to reduce stroke during transcatheter aortic valve implantation.
Does routine cerebral embolic protection reduce the incidence of stroke at 72 hours in adult patients undergoing TAVI?
Population
7,730 adult patients scheduled for TAVI across the United Kingdom able to receive a CEP device
Comparison
TAVI with CEP vs TAVI without CEP (standard of care)
Design
Prospective, open-label, outcome-adjudicated, multicentre randomised controlled trial
Follow-up
72 hours for primary outcome, up to 12 months for secondary outcomes
Authors
Discussion
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Implication
The BHF PROTECT-TAVI trial is designed to provide definitive evidence on the clinical efficacy and cost-effectiveness of using routine cerebral embolic protection to reduce stroke in TAVI.
Structured PICO
Does routine cerebral embolic protection reduce the incidence of stroke at 72 hours in adult patients undergoing TAVI?
P
Population
Adult patients scheduled for TAVI at participating specialist cardiac centres across the United Kingdom who are able to receive the CEP device. Target n=7,730.
I
Intervention
TAVI with routine cerebral embolic protection (CEP) using the SENTINEL device
C
Comparator
TAVI without CEP (standard of care)
O
Outcome
Incidence of stroke at 72 hours post-TAVIhard clinical
The BHF PROTECT-TAVI trial is designed to provide definitive evidence on the clinical efficacy and cost-effectiveness of using routine cerebral embolic protection to reduce stroke in TAVI.
Cite This Study
Kharbanda et al. (2023) studied this question.