Regional Benefits? U.S. Cohort Shows Stroke Reduction in PROTECTED TAVR Analysis with Use of Cerebral Embolic Protection

At TCT 2024, findings from a U.S. subgroup analysis of the PROTECTED TAVR trial highlighted potential regional differences in the efficacy of cerebral embolic protection (CEP) during transcatheter aortic valve replacement (TAVR). Published in JAMA Cardiology, this post hoc analysis explored whether the Sentinel CEP device, designed to capture embolic debris during TAVR, effectively reduced stroke risk in the U.S. cohort compared to international patients.

The main PROTECTED TAVR trial enrolled 3,000 patients across the U.S., Europe, and Australia, randomizing them to TAVR with or without CEP. While the overall trial found no significant reduction in periprocedural stroke (2.3% with CEP vs. 2.9% without), it did demonstrate a notable 62% reduction in disabling stroke within the entire study population (0.5% with CEP vs. 1.3% without). The U.S. subgroup analysis showed that CEP use was associated with a 50% relative reduction in any stroke (2.6% to 1.3%) and a 73% reduction in disabling stroke (1.5% to 0.4%) compared to TAVR alone. However, these benefits were not observed in patients treated outside the U.S., where stroke rates remained similar between CEP and control groups.

Differences in patient characteristics and procedural practices between regions may partially explain these findings. The U.S. cohort included a higher prevalence of patients with bicuspid aortic valves, diabetes, and peripheral vascular disease, and 78% received balloon-expandable valves compared to 42% in the international cohort. Despite these findings, the main trial did not find a statistically significant interaction by region, and these results remain hypothesis-generating.

The U.S.-specific benefits observed in PROTECTED TAVR suggest that regional factors, including patient selection and procedural variation, could influence CEP efficacy during TAVR. Further studies are needed to confirm these findings and to determine whether patient- or procedure-specific factors in different regions impact the benefits of embolic protection during TAVR. The results of the larger BHF-PROTECTED TAVR trial are eagerly awaited.

References

Makkar RR, Gupta A, Waggoner TE, et al. Cerebral Embolic Protection by Geographic Region: A Post Hoc Analysis of the PROTECTED TAVR Randomized Clinical Trial. JAMA Cardiol. 2024; DOI:10.1001/jamacardio.2024.4278. Published online October 29, 2024.