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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

CharacteristicControlActive
Age-yr81.3 ± 6.581.2 ± 6.5
Female sex38.4%39.1%
White93.2%93.4%
Hypertension67.4%68.4%
Hypercholesterolemia60.4%63.4%
Diabetes20.2%20.9%
History of TIA7.8%8.5%
History of stroke6.3%5.8%
Atrial fibrillation/flutter33.8%33.5%
Heart failure12.8%14.1%
CAD32.9%34.6%
EuroSCORE II2.4 (1.6–4.0)2.4 (1.6–4.1)
LVEF ≥50%76.9%76.2%

Arms

FieldCEP groupControl
InterventionTAVI with Sentinel cerebral embolic protection deviceTAVI without cerebral embolic protection device
DurationUp to 72 hours after TAVI or until dischargeUp to 72 hours after TAVI or until discharge

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Stroke within 72 hours after TAVI or before discharge (if earlier)Primary2.2%2.1%Difference -0.1 percentage points (95% CI -0.68 to 0.63)0.94
Disabling stroke (6–8 weeks)Secondary1.4%1.2%0.89
Death within 72h or before dischargeSecondary0.7%0.8%1.12
Composite of stroke or deathSecondary2.7%2.8%1.04
Severe strokeSecondary0.5%0.5%0.95
Serious adverse eventsAdverse0.3%0.6%
Overall access-site complicationsAdverse7.7%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)

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

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

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