The incidence of stroke within 3 days is not decreased by routine use of cerebral embolic protection (CEP) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). These data were presented by Rajesh Kharbanda, MBChB, PhD, during a late-breaking clinical trial session on Sunday at the American College of Cardiology (ACC) Scientific Sessions 2025. Results were simultaneously published in the New England Journal of Medicine. Patients who undergo TAVI are at heightened risk for unpredictable, procedure-related stroke. This also raises the risk of death. Evidence has shown mixed results for the use of CEP during TAVI for protection against stroke, but CEP may reduce the risk of embolic stroke by capturing debris. This study, the BHF PROTECT-TAVI (British Heart Foundation Randomized Trial of Routine Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation) took place across 33 centers in the U.K. and randomized a total of 7,635 patients 1:1 to receive TAVI with a CEP device or TAVI without a CEP device. Stroke within 72 hours post-TAVI or before discharge from the hospital was the primary endpoint in this study. The CEP group consisted of 3,815 patients (mean age=81.2 years, 39.1% female) and the control group consisted of 3,820 patients (mean age=81.3 years, 38.4% female). The primary outcome was observed in 2.1% of patients in the CEP group and 2.2% of patients in the control group (95% confidence interval [CI]: -0.68 to 0.63, p=0.94). In the CEP group, 1.2% of patients experienced disabling stroke, as opposed to 1.4% in the control group. Access site complications were also similar between groups (CEP=8.1%, control=7.7%). Serious adverse events occurred in 0.6% of the CEP group and 0.3% of the control group, making for 24 in total. Overall, the use of CEP devices in patients undergoing TAVI did not mitigate the number of strokes that occurred compared with patients who did not have a CEP device during TAVI. “We need to understand which patients are at higher risk of stroke during TAVR and whether a more stratified approach to delivering therapy to those people is beneficial,” Dr. Kharbanda said in a press release on Sunday. This study was sponsored by the British Heart Foundation (BHF) and Boston Scientific. Source: Kharbanda RK, Kennedy J, Jamal Z, et al. Routine cerebral embolic protection during Transcatheter Aortic Valve Implantation. N Engl J Med. 2025 March 30 (Article in press). Image Credit: Screenshot by Bailey G. Salimes. Image Caption: Rajesh Kharbanda, MBChB, PhD, presents during a press conference on Sunday at the American College of Cardiology (ACC) Scientific Sessions 2025.