Valvular & structural heart disease

Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation

N Engl J MedPublished Randomised controlled trial

Primary resultResult — go to the resultDifference −0.02 percentage points 95% CI −0.68 to 0.63

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)
Methodological detailsmulticentre, 33 UK centres
  • Multicentre
  • 33 UK centres

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

CEPvs 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

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