Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation.
Kharbanda RK., Kennedy J., Jamal Z., Dodd M., Evans R., Bal KK., Perkins AD., Blackman DJ., Hildick-Smith D., Banning AP., Baumbach A., Ludman P., Palmer S., Stables RH., Henderson R., Appleby C., Cotton J., Curzen N., Ozkor M., Byrne J., Aggarwal R., Das R., Doshi S., Watkins S., Muir DF., Anderson R., Chowdhary S., Varcoe R., Dorman S., Firoozi S., Chelliah R., Owens C., Redwood S., Prendergast B., Iqbal J., Ratib K., Dospinescu C., Suresh V., Cruden N., Rajathurai T., Malik IS., Wiper A., Costopoulos C., Khurana A., Banning A., Clayton T., BHF PROTECT-TAVI Investigators None.
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.).