Cerebral embolic protection during TAVR did not reduce overall stroke
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BOSTON — In PROTECTED TAVR, the largest-ever randomized trial of transcatheter aortic valve replacement, cerebral embolic protection did not decrease incidence of periprocedural stroke.
However, cerebral embolic protection was associated with reduced incidence of disabling stroke, so the results do not necessarily rule out the benefit of cerebral embolic protection in patients undergoing TAVR, Samir R. Kapadia, MD, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, said during a press conference at TCT 2022.
“As a scientific trial, you would say that the primary endpoint was negative,” Kapadia said at the press conference. “However, the disabling strokes are reduced, so it would be the wrong message to say there was no benefit. [We had to state] the conclusion without overstating it or misguiding the readership.”
The researchers randomly assigned 3,000 patients with aortic stenosis to undergo transfemoral TAVR with or without a cerebral embolic protection device (Sentinel, Boston Scientific).
The primary endpoint was stroke within 72 hours of TAVR or before discharge, whichever came first, in the intention-to-treat population. Secondary endpoints included disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the cerebral embolic protection access site and acute kidney injury. All patients were assessed by a neurologist before and after the procedure.
The results were simultaneously published in The New England Journal of Medicine.
Among the patients from the cerebral embolic protection arm in whom an attempt was made, 94.4% had the device successfully deployed, according to the researchers.
The primary endpoint occurred in 2.3% of the cerebral embolic protection group and 2.9% in the control group (difference, –0.6 percentage points; 95% CI, –1.7 to 0.5; P = .3), Kapadia and colleagues found.
Disabling stroke occurred in 0.5% of the cerebral embolic protection group and 1.3% of the control group (difference, –0.8 percentage points; 95% CI, –1.5 to –0.1; P = .02), according to the researchers. The number needed to treat with cerebral embolic protection to prevent one disabling stroke was 125, Kapadia said at the press conference.
The difference in disabling stroke was driven by disabling ischemic stroke, with six occurring in the cerebral embolic protection group and 17 occurring in the control group, Kapadia said.
There were no differences between the groups in death (cerebral embolic protection, 0.5%; controls, 0.3%), stroke/TIA/delirium (cerebral embolic protection, 3.1%; controls, 3.7%) or acute kidney injury (0.5% in both groups), Kapadia and colleagues found.
One patient in the cerebral embolic protection group had a vascular complication at the device access site, according to the researchers.
A cerebral embolic protection device could not be deployed in 5.5% of patients assigned to that group, but a per-protocol analysis of patients who received the assigned treatment did not differ from the intention-to-treat analysis, the researchers reported.
There were no differences in the primary outcome by subgroup except that it significantly favored the cerebral embolic protection group in patients from the U.S. but not in patients from outside the U.S., and the researchers do not have an explanation for why that happened, Kapadia said.
“Stroke remains unpredictable,” Kapadia said at the press conference. “Despite a big effort, we did not identify who is likely to have them.”
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Any complication for a patient is a terrible thing. We lose sleep over the thought of a patient suffering a stroke or dying. Arguably, a disabling stroke might be worse than death.
What we have talked about programmatically is how to select the patients who would most benefit from a cerebral embolic protection device. It would be easier to answer the question if the subgroup analyses showed clearly that any patient subsets might benefit. What some programs are doing is in patients who are at higher risk for stroke — a prior stroke, significant calcium in the arch, very tortuous disease or other risk factors of their valve observed on echocardiography — taking a look very closely at the available data and trying to decide as a group where it makes sense to integrate cerebral embolic protection into practice. Cost considerations are important, too. Many hospitals operate on thin margins, so the decision to use the device will be very individualized.
It is great that we are studying this issue, because while the majority of our patients who have TAVR do well, there are some who are prone to having a transient ischemic attack or stroke after the procedure, and we worry about that.
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Kapadia SR, et al. Late-Breaking Clinical Science in Structural Heart Disease: Session I, in Collaboration with The New England Journal of Medicine. Presented at: TCT Scientific Symposium; Sept. 16-19, 2022; Boston (hybrid meeting).
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