Does cerebral embolic protection prevent stroke in patients undergoing TAVR? PROTECTED TAVR provides answer

USA: The use of cerebral embolic protection (CEP) among patients with aortic stenosis undergoing transfemoral TAVR did not reduce the risk of periprocedural stroke, recent data from PROTECTED TAVR shows.

The researchers further add that the results may not preclude a benefit of CEP during TAVR. "There were lesser disabling strokes with protection, and the procedure itself was safe," Samir R. Kapadia, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, and colleagues wrote in their study. The findings were presented at the TCT 2022 and published in the New England Journal of Medicine.

Transcatheter aortic-valve replacement (TAVR) for treating aortic stenosis can result in the embolization of debris. The risk of stroke may be reduced by capturing debris that provides cerebral embolic protection.

The study included patients with aortic stenosis. They were randomly assigned 1:1 to receive transfemoral TAVR with CEP, which constituted the CEP group, and the control group without CEP. Stroke within 72 hours after TAVR or prior to discharge was the study's primary endpoint in the intention-to-treat population. The following parameters were assessed: death, disabling stroke, delirium, transient ischemic attack, acute kidney injury, and major or minor vascular complications at the CEP access site. All patients were examined at baseline and after TAVR by a neurology professional.

The study led to the following findings:

A total of 3000 patients across Europe, North America, and Australia underwent randomization; 1501 were allocated to the CEP group, and in the control group 1499 people were included.

Successfully deployed of the CEP device was done in 1406 of the 1489 patients (94.4%) in whom an attempt was made.

There was no significant difference in the stroke incidence within 72 hours after TAVR or before discharge between the CEP group and the control group (2.3% vs. 2.9%; difference).

Disabling stroke was seen in 0.5% of the patients in the CEP group and 1.3% in the control group.

There were no notable differences between the CEP group and the control group in the percentage of patients who died (0.5% vs. 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% vs. 3.7%); or had acute kidney injury (0.5% vs. 0.5%).

At the CEP access site, one patient (0.1%) had a vascular complication.

"Aortic stenosis patients undergoing transfemoral TAVR, CEP use did not significantly affect the incidence of periprocedural stroke; the results may not rule out a benefit of CEP during TAVR based on the 95% confidence interval around this outcome," the researchers conclude.

Reference:

Kapadia SR, Makkar R, Leon M, et al. Cerebral embolic protection during transcatheter aortic valve replacement. N Engl J Med. 2022; Epub ahead of print.