| Title: |
Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation. |
| Authors: |
Kharbanda, Rajesh K; Kennedy, James; Jamal, Zahra; Dodd, Matthew; Evans, Richard; Bal, Kiran K; Perkins, Alexander D; Blackman, Daniel J; Hildick-Smith, David; Banning, Adrian P; Baumbach, Andreas; Ludman, Peter; Palmer, Stephen; Stables, Rodney H; Henderson, Robert; Appleby, Clare; Cotton, James; Curzen, Nick; Ozkor, Muhiddin; Byrne, Jonathan; Aggarwal, Rajesh; Das, Rajiv; Doshi, Sagar; Watkins, Stuart; Muir, Douglas F; Anderson, Richard; Chowdhary, Saqib; Varcoe, Richard; Dorman, Stephen; Firoozi, Sam; Chelliah, Raj; Owens, Colum; Redwood, Simon; Prendergast, Bernard; Iqbal, Javaid; Ratib, Karim; Dospinescu, Ciprian; Suresh, Venkatesan; Cruden, Nicholas; Rajathurai, Thirumaran; Malik, Iqbal S; Wiper, Andrew; Costopoulos, Charis; Khurana, Ayush; Banning, Amerjeet; Clayton, Tim; BHF PROTECT-TAVI Investigators |
| Publisher Information: |
Massachusetts Medical Society |
| Publication Year: |
2025 |
| Collection: |
London School of Hygiene & Tropical Medicine: LSHTM Research Online |
| Description: |
BACKGROUND: Transcatheter aortic-valve implantation (TAVI) is associated with procedure-related stroke. Cerebral embolic protection (CEP) devices may reduce embolization to the cerebral circulation and hence the incidence of stroke. METHODS: We conducted a randomized, controlled trial across 33 centers in the United Kingdom. We randomly assigned 7635 participants with aortic stenosis in a 1:1 ratio to undergo TAVI with a CEP device (CEP group) or TAVI without a CEP device (control group). The primary outcome was stroke within 72 hours after TAVI or before discharge from the hospital (if discharge occurred sooner). RESULTS: A total of 3815 participants were assigned to the CEP group and 3820 to the control group. A primary-outcome event occurred in 81 of 3795 participants (2.1%) in the CEP group and in 82 of 3799 participants (2.2%) in the control group (difference, -0.02 percentage points; 95% confidence interval, -0.68 to 0.63; P = 0.94). Disabling stroke occurred in 47 participants (1.2%) in the CEP group and in 53 (1.4%) in the control group. Death occurred in 29 participants (0.8%) in the CEP group and in 26 (0.7%) in the control group. Overall access-site complications appeared to be similar in the two groups (8.1% in the CEP group and 7.7% in the control group). A total of 24 serious adverse events occurred in 22 of 3798 participants (0.6%) in the CEP group, and 13 serious adverse events occurred in 13 of 3803 participants (0.3%) in the control group. CONCLUSIONS: Among participants undergoing TAVI, routine use of CEP did not decrease the incidence of stroke within 72 hours. (Funded by the British Heart Foundation and Boston Scientific; BHF PROTECT-TAVI ISRCTN Registry number, ISRCTN16665769.). |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| ISSN: |
0028-4793 |
| Relation: |
https://researchonline.lshtm.ac.uk/id/eprint/4675788/1/Kharbanda-etal-2025-Routine-Cerebral-Embolic-Protection-during-Transcatheter-Aortic-Valve-Implantation.pdf; Kharbanda, Rajesh K; Kennedy, JamesORCID logo; Jamal, Zahra ORCID logo; Dodd, Matthew ORCID logo; Evans, Richard; Bal, Kiran K; Perkins, Alexander D; Blackman, Daniel J; Hildick-Smith, David; Banning, Adrian P; +37 more.Baumbach, Andreas; Ludman, Peter; Palmer, Stephen; Stables, Rodney H; Henderson, Robert; Appleby, Clare; Cotton, James; Curzen, Nick; Ozkor, Muhiddin; Byrne, Jonathan; Aggarwal, Rajesh; Das, Rajiv; Doshi, Sagar; Watkins, Stuart; Muir, Douglas FORCID logo; Anderson, Richard; Chowdhary, Saqib; Varcoe, Richard; Dorman, Stephen; Firoozi, Sam; Chelliah, Raj; Owens, Colum; Redwood, Simon; Prendergast, Bernard; Iqbal, Javaid; Ratib, Karim; Dospinescu, Ciprian; Suresh, Venkatesan; Cruden, Nicholas; Rajathurai, Thirumaran; Malik, Iqbal S; Wiper, Andrew; Costopoulos, Charis; Khurana, Ayush; Banning, Amerjeet; Clayton, Tim ORCID logo; and BHF PROTECT-TAVI Investigators (2025) Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation. New England Journal of Medicine, 392 (24). pp. 2403-2412. ISSN 0028-4793 DOI:10.1056/NEJMoa2415120 |
| DOI: |
10.1056/nejmoa2415120 |
| Availability: |
https://researchonline.lshtm.ac.uk/id/eprint/4675788/; https://doi.org/10.1056/nejmoa2415120 |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.BD5E5739 |
| Database: |
BASE |