The routine use of cerebral embolic protection during transcatheter aortic valve implantation didn't reduce the rate of stroke within 72 hours following the procedure, according to a randomized controlled trial.
In the BHF PROTECT-TAVI trial, researchers enrolled 7635 patients with aortic stenosis across 33 sites in the United Kingdom. The participants were randomly assigned 1:1 to undergo transcatheter aortic valve implantation (TAVI) either with or without the Sentinel cerebral embolic protection (CEP) device. The primary outcome was any stroke occurring within 72 hours postprocedure or prior to hospital discharge, whichever occurred first.
Stroke occurred in 2.1% of patients (n = 81/3,795) in the CEP group and 2.2% (n = 82/3,799) in the control group (risk difference = –0.02 percentage points, 95% confidence interval = –0.68 to 0.63, P = .94).
“Routine use of CEP did not decrease the incidence of stroke within 72 hours,” said lead study author Rajesh K. Kharbanda, PhD, of the Department of Cardiovascular Medicine at the John Radcliffe Hospital, and colleagues.
Disabling stroke occurred in 1.2% of patients in the CEP group and 1.4% in the control group. Severe stroke—defined as a National Institutes of Health Stroke Scale (NIHSS) score of 10 or higher—was reported in 0.5% of each group. Mortality within 72 hours occurred in 0.8% of the CEP group and 0.7% of the control group.
Both filters of the CEP device were fully deployed in 81.2% of the assigned patients; at least one filter was deployed in 87.5% of cases. The device was designed to capture embolic debris during TAVI that may otherwise reach the cerebral circulation.
The mean patient age was 81.2 years, and 38.7% were female. Baseline characteristics, including rates of hypertension, hypercholesterolemia, atrial fibrillation, and prior stroke or transient ischemic attack, were similar between the groups.
Serious adverse events occurred in 0.6% of the patients in the CEP group compared with 0.3% of those in the control group. Access-site complications were reported in 8.1% of patients in the CEP group and 7.7% of those in the control group. These differences were not statistically significant.
An interim analysis led to early trial termination because of futility. The researchers determined that the probability of CEP reducing stroke incidence by the 40% threshold set in the study protocol was low.
Subgroup analysis and compliance-adjusted causal effect modeling showed no significant treatment effects. The findings were consistent with those of the PROTECTED TAVR trial, which also found no reduction in early stroke risk with CEP.
The study defined stroke based on symptoms lasting more than 24 hours. Imaging alone was not sufficient for diagnosis. All stroke events were adjudicated by a blinded, independent clinical events committee.
Authors’ disclosures are available in the study.