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BHF PROTECT-TAVI

Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation

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Year of Publication: 2025

Authors: Rajesh K. Kharbanda, James Kennedy, Zahra Jamal, ..., Tim Clayton

Journal: The New England Journal of Medicine

Citation: N Engl J Med 2025;392:1288-96. DOI: 10.1056/NEJMoa2415120

Link: https://www.nejm.org/doi/10.1056/NEJMoa2415120

PDF: https://www.ahajournals.org/doi/pdf/10.1161/01.STR.29.1.4

Clinical Question

Does routine use of cerebral embolic protection (CEP) during transcatheter aortic-valve implantation (TAVI) reduce the incidence of stroke within 72 hours after the procedure?

Bottom Line

Routine use of cerebral embolic protection during TAVI did not reduce stroke incidence within 72 hours or before hospital discharge and had no significant benefit for disabling stroke or mortality.

        Major Points
        7635 patients undergoing TAVI were randomized 1:1 to CEP device (Sentinel) vs no CEP.
Primary outcome (stroke within 72h or before discharge): 2.1% (CEP) vs 2.2% (control); P=0.94.
Disabling stroke: 1.2% (CEP) vs 1.4% (control); Death: 0.8% (CEP) vs 0.7% (control).
Serious adverse events: 0.6% (CEP) vs 0.3% (control); not statistically significant.
Trial stopped early for futility after crossing prespecified threshold.
No subgroup showed significant benefit for CEP.

      

Design

Study Type: Multicenter, open-label, randomized controlled trial with blinded outcome adjudication

Randomization: 1

Blinding: Outcomes adjudicated by a blinded independent clinical events committee

Enrollment Period: October 29, 2020 to October 9, 2024

Follow-up Duration: Up to 72 hours after TAVI or discharge, whichever came first

Centers: 33

Countries: United Kingdom

Sample Size: 7635

Analysis: Modified intention-to-treat; generalized linear models for risk ratios and differences; CACE analysis; subgroup interaction terms; performed using Stata 17

Inclusion Criteria

Age ≥18 years
Diagnosis of aortic stenosis and scheduled for TAVI
Clinically and anatomically suitable for Sentinel CEP device (as judged by physician)
Provided written informed consent

Baseline Characteristics

Characteristic	Control	Active
Age-yr	81.3 ± 6.5	81.2 ± 6.5
Female sex	38.4%	39.1%
White	93.2%	93.4%
Hypertension	67.4%	68.4%
Hypercholesterolemia	60.4%	63.4%
Diabetes	20.2%	20.9%
History of TIA	7.8%	8.5%
History of stroke	6.3%	5.8%
Atrial fibrillation/flutter	33.8%	33.5%
Heart failure	12.8%	14.1%
CAD	32.9%	34.6%
EuroSCORE II	2.4 (1.6–4.0)	2.4 (1.6–4.1)
LVEF ≥50%	76.9%	76.2%

Arms

Field	CEP group	Control
Intervention	TAVI with Sentinel cerebral embolic protection device	TAVI without cerebral embolic protection device
Duration	Up to 72 hours after TAVI or until discharge	Up to 72 hours after TAVI or until discharge

Outcomes

Outcome	Type	Control	Intervention	HR / OR / RR	P-value
Stroke within 72 hours after TAVI or before discharge (if earlier)	Primary	2.2%	2.1%	Difference -0.1 percentage points (95% CI -0.68 to 0.63)	0.94
Disabling stroke (6–8 weeks)	Secondary	1.4%	1.2%	0.89
Death within 72h or before discharge	Secondary	0.7%	0.8%	1.12
Composite of stroke or death	Secondary	2.7%	2.8%	1.04
Severe stroke	Secondary	0.5%	0.5%	0.95
Serious adverse events	Adverse	0.3%	0.6%
Overall access-site complications	Adverse	7.7%	8.1%

Subgroup Analysis

No subgroup (e.g., age, sex, valve type, prior stroke) showed benefit from CEP. No statistically significant interactions.

Criticisms

Trial stopped early for futility; may have reduced power to detect smaller benefits.
Event rate for stroke was lower than expected, limiting power.
Subgroup analyses were not powered and may have been underpowered for rare outcomes.
Operator experience with CEP varied; no formal run-in phase.
Eligibility for CEP use was based on local physician judgment without core lab review.

Funding

British Heart Foundation and Boston Scientific

Based on: BHF PROTECT-TAVI (The New England Journal of Medicine, 2025)