Valvular & structural heart diseaseRandomised controlled trial
Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation
- Randomised controlled trial
- multicentre
- 33 UK centres
Authors' conclusion
Among participants undergoing TAVI, routine use of CEP did not decrease the incidence of stroke within 72 hours.
Study context
- Population
- Patients with AS undergoing transcatheter aortic-valve implantation (TAVI), UK
- Participants
- 7,635 patients
- Comparison
- TAVI with cerebral embolic protection (CEP) device vs TAVI without CEP device
- CEPn = 3,815
- Controln = 3,820reference
- Primary endpoint
- Stroke
- Follow-up
- Within 72 hours after TAVI or before discharge (if sooner)
Primary result
As reported in the abstract
Difference
−0.02 percentage points
95% CI −0.68 to 0.63
P = 0.94
Events by treatment group
CEP vs Control
difference −0.02 percentage points (95% CI −0.68 to 0.63); P = 0.94
Further findings
Disabling stroke
Death
Safety
Overall access-site complications
Serious adverse events
Events CEP 24 · Control 13
Participants assessed CEP 3798 · Control 3803
Overall access-site complications
- Appeared similar in the two groups
Original publication
Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation. N Engl J Med. Published 30 March 2025. doi:10.1056/nejmoa2415120
Summarised from the published abstract; every number is checked against it