Use of a cerebral embolic protection (CEP) device did not decrease the incidence of stroke within 72 hours after participants underwent TAVI, according to new research presented during a Late-Breaking Clinical Trial session at ACC.25 in Chicago and simultaneously published in NEJM.

The largest randomized trial to assess the use of a CEP device during TAVI, BHF PROTECT-TAVI was conducted between 2020 and 2024 at 33 centers across the UK. Investigators randomized 7,635 participants (mean age 81.2 years, 38.7% women) with aortic stenosis to undergo TAVI either with the SENTINEL CEP device (n=3,815) or without (n=3,280).

Results showed that 81 (2.1%) of patients in the CEP group and 82 (2.2%) patients in the control group suffered a stroke within 72 hours of TAVI or discharge from the hospital if discharge occurred sooner, showing no evidence of a difference between the two study arms. Results for secondary endpoints were also similar between groups, including all-cause mortality (0.8% vs. 0.7% in the CEP and control groups), disabling stroke (1.2% vs. 1.4%), stroke severity and cognitive outcomes, as well as access-site complications (8.1% vs. 7.7%) and serious adverse events (0.6% vs. 0.3%). No differences in outcomes were seen in any subgroups that were analyzed.

Recruitment for the trial was stopped after the interim analysis based on these findings.

"This large, well-conducted, appropriately powered clinical trial has addressed the question of whether the SENTINEL cerebral embolic protection device is effective in an unselected cohort of TAVI patients," said Rajesh Kharbanda, MD, the study's first author. "In our population, a routine strategy of cerebral embolic protection did not reduce the rate of stroke. Our study provides convincing evidence that there is no value in the routine use of this device during TAVI."

Although the trial showed current cerebral embolic protection devices do not improve outcomes, Kharbanda said it is possible that next-generation embolic protection devices could potentially reduce stroke risk for certain groups, but further trials would be needed to demonstrate this.

"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," said Kharbanda.