WASHINGTON — In an exploratory analysis of the PROTECTED TAVR trial of patients undergoing transcatheter aortic valve replacement, cerebral embolic protection reduced risk for short-term stroke in patients from the U.S. but not elsewhere.
As Healio previously reported, in the main findings of PROTECTED TAVR, cerebral embolic protection (Sentinel, Boston Scientific) did not decrease incidence of periprocedural stroke. The findings from a post hoc analysis comparing outcomes by geographic region were presented at TCT 2024 and simultaneously published in JAMA Cardiology.
The post hoc analysis was undertaken because, in contrast to main results of PROTECTED TAVR, data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry of U.S. patients who underwent TAVR suggest cerebral embolic protection benefits those who have 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, told Healio.
The trial included 3,000 patients with severe aortic stenosis undergoing TAVR (mean age, 79 years; 60% men) who were randomly assigned to receive cerebral embolic protection or not. For the post hoc analysis, the researchers compared the 1,833 patients from the U.S. with the 1,167 patients from outside the U.S.
The U.S. patients differed from the non-U.S. patients in many ways, including that they were younger; less likely to be female; less likely to be at high operative risk; more likely to have diabetes, peripheral vascular disease or CAD; less likely to have atrial fibrillation; more likely to be treated with a balloon-expandable TAVR valve and less likely to undergo predilation, Kapadia said.
In the U.S. cohort, the primary outcome of clinical stroke within 72 hours after TAVR or before discharge occurred less frequently in the embolic protection group than in the control group (1.3% vs. 2.6%; difference, –1.3 percentage points; 95% CI, –2.6 to 0; P = .045), but that was not the case in the non-U.S. cohort (embolic protection group, 3.7%; control group, 3.3%; difference, 0.5 percentage points; 95% CI, –1.6 to 2.6; P = .662), Kapadia said, noting that there was no significant interaction by geography.
The outcome of disabling stroke within 72 hours after TAVR or before discharge favored the embolic protection group in the U.S. cohort (0.4% vs. 1.5%; P = .018) but not in the non-U.S. cohort (embolic protection, 0.7%; control, 1%; P = .545), he said.
“This is a subgroup analysis and is hypothesis-generating,” Kapadia said. “But we asked what made the U.S. population so different. They used more balloon-expandable valves [and] there were more patients who were somewhat embolized in the sense that ... they were younger, had more peripheral disease and had more calcified valves. The idea is that these patients are more likely to have a stroke of an embolic nature. That may be a reason why they got a better benefit [from cerebral protection]. We could not find the exact mechanics of why there is a difference, but the benefit in the U.S. population was similar to what we saw in the TVT analysis. It is interesting to know that there may be something different with the way the procedure is done here.”
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