BHF PROTECT-TAVI
Trial question
What is the effect of routine use of a cerebral embolic protection device in patients with aortic stenosis undergoing TAVI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 7601
7601 patients (2945 female, 4656 male).
Inclusion criteria: adult patients with aortic stenosis undergoing TAVI.
Key exclusion criteria: anatomically unsuitable for treatment with cerebral embolic protection device; clinical contraindications to the use of cerebral embolic protection device.
Interventions
N=3798 cerebral embolic protection device (TAVI with a sentinel cerebral embolic protection device).
N=3803 no cerebral embolic protection device (TAVI without a sentinel cerebral embolic protection device).
Primary outcome
Stroke within 72 hours after transcatheter aortic valve implantation or before discharge
2.1%
2.2%
2.2 %
1.7 %
1.1 %
0.6 %
0.0 %
Cerebral embolic protection
device
No cerebral embolic protection
device
No significant
difference ↔
No significant difference in stroke within 72 hours after TAVI or before discharge (2.1% vs. 2.2%; RR 0.99, 99% CI 0.73 to 1.34).
Secondary outcomes
No significant difference in the rate of disabling stroke within 6-8 weeks after TAVI (1.2% vs. 1.4%; RR 0.89, 95% CI 0.6 to 1.31).
No significant difference in severe stroke within 72 hours after TAVI or before discharge (0.5% vs. 0.5%; RR 0.95, 95% CI 0.5 to 1.8).
No significant difference in death or stroke within 72 hours after TAVI or before discharge (2.8% vs. 2.7%; RR 1.04, 95% CI 0.8 to 1.36).
Safety outcomes
No significant difference in clinical complications and adverse events.
Conclusion
In adult patients with aortic stenosis undergoing TAVI, cerebral embolic protection device was not superior to no cerebral embolic protection device with respect to stroke within 72 hours after TAVI or before discharge.
Reference
Rajesh K Kharbanda, James Kennedy, Zahra Jamal et al. Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation. N Engl J Med. 2025 Mar 30. Online ahead of print.
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