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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;392:2403-2412. DOI: 10.1056/NEJMoa2415120

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

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: 3815 to CEP (Sentinel) and 3820 to control; modified intention-to-treat analysis included 3795 vs 3799 after exclusions.
  • Primary outcome (stroke within 72h or before discharge): 2.1% (CEP) vs 2.2% (control); risk difference -0.02 pp (95% CI -0.68 to 0.63); P=0.94.
  • Disabling stroke at 6-8 wk: 1.2% (CEP) vs 1.4% (control); Death within 72h/discharge: 0.8% (CEP) vs 0.7% (control).
  • Serious adverse events: 22/3798 (0.6%) CEP vs 13/3803 (0.3%) control.
  • Trial stopped early for futility after crossing prespecified threshold (99% CI excluded 40% RRR).
  • 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: Primary and most secondary outcomes assessed within 72 hours after TAVI or before hospital discharge (if sooner); disabling stroke and access-site complications also evaluated at 6 to 8 weeks after TAVI

Centers: 33

Countries: United Kingdom

Sample Size: 7635

Analysis: Modified intention-to-treat; generalized linear models for risk ratios and differences; CACE analysis via two-stage least-squares instrumental variable regression; prespecified 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 treating 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 discharge (with additional 6-8 week follow-up for disabling stroke and access-site complications)Up to 72 hours after TAVI or until discharge (with additional 6-8 week follow-up for disabling stroke and access-site complications)

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Stroke within 72 hours after TAVI or before discharge (if earlier)Primary2.2%2.1%Risk Difference -0.02 percentage points (95% CI -0.68 to 0.63); Risk Ratio 0.99 (95% CI 0.73 to 1.34)0.94
Disabling stroke at 6-8 weeks after TAVISecondary1.4%1.2%
Death within 72h or before dischargeSecondary0.7%0.8%
Composite of death or stroke within 72h or before dischargeSecondary2.7%2.8%
Severe stroke (NIHSS ≥10) within 72h or before dischargeSecondary0.5%0.5%
Death, stroke, or TIA within 72h or before dischargeSecondary3.1%3.3%
Serious adverse eventsAdverse13/3803 (0.3%)22/3798 (0.6%)
Access-site complications before dischargeAdverse290/3776 (7.7%)304/3772 (8.1%)Risk difference 0.4 pp (95% CI -0.8 to 1.6)
Access-site complications at aortogram site between discharge and 6-8 weeksAdverse13/3378 (0.4%)27/3347 (0.8%)Risk difference 0.4 pp (95% CI 0.1 to 0.8)

Subgroup Analysis

No subgroup (e.g., age, sex, valve type, EuroSCORE II, native bicuspid valve, aortic-valve calcification, balloon dilation) 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.
  • Open-label design; only outcome adjudication was blinded.
  • Majority of participants were White; minority racial/ethnic groups underrepresented.

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;392:2403-2412. DOI: 10.1056/NEJMoa2415120

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