A post hoc analysis of the PROTECTED TAVR trial suggests a trend toward greater stroke reduction with cerebral embolic protection (CEP) during TAVR in the U.S. cohort, while this effect was not seen in the Europe and Australia cohort. Samir R. Kapadia, MD, of the Cleveland Clinic, Ohio, presented these findings on Tuesday at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference in Washington, DC, with a concurrent publication in JAMA Cardiology. The original PROTECTED TAVR (Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement) study, published by Kapadia et al. in The New England Journal of Medicine in 2022, randomized 3000 patients with aortic stenosis across North America, Europe and Australia to receive TAVR with or without CEP. The original trial found no significant difference in stroke incidence within 72 hours post-TAVR or before discharge between the CEP and control groups (2.3% vs. 2.9%; difference, −0.6 percentage points; 95% confidence interval [CI]: −1.7 to 0.5; P=0.30). Disabling stroke occurred in 0.5% of patients in the CEP group versus 1.3% in the control group, with no notable differences in mortality or other adverse events between groups. The study randomization was stratified by center, operative risk and intended TAVR valve type, with 1833 patients in the U.S. cohort (914 receiving TAVR with CEP, 919 with TAVR alone) and 1167 patients in the non-U.S. cohort (587 receiving TAVR with CEP, 580 with TAVR alone). Post hoc analysis showed that U.S. patients tended to be younger, predominantly male and had higher rates of bicuspid aortic valve, diabetes and peripheral vascular disease, along with lower rates of atrial fibrillation compared to the non-U.S. cohort. In the U.S. cohort, CEP use was linked to a 50% relative reduction in overall stroke risk (1.3% in the CEP group vs. 2.6% in the control group; difference, −1.3 percentage points; 95% CI: −2.6 to 0.0) and a 73% reduction in disabling stroke (0.4% in the CEP group vs. 1.5% in the control group; difference, −1.1 percentage points; 95% CI: −2.0 to −0.2) compared to TAVR alone. However, these stroke risk reductions were not observed in the non-U.S. cohort, and mortality rates remained similar across both regions. These findings suggest that regional differences in procedural practices and patient characteristics may influence the efficacy of CEP in reducing TAVR-related stroke. However, the exploratory analysis by geographic region was not pre-specified, and the study was not powered to detect clinical outcome differences within these subgroups. Moreover, no interaction with geographic region was identified in the overall analysis, so these findings should be considered hypothesis-generating and complementary to other literature, the investigators of the study noted. Source: 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 10 29 (Article in press). Image Caption: Samir R. Kapadia, MD, speaks during a news conference Tuesday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC Image Credit: Bailey G. Salimes/CRTonline.org