Cerebral Embolic Protection by Geographic Region: A Post Hoc Analysis of the PROTECTED TAVR Randomized Clinical Trial

Area of Science:

• Cardiovascular Medicine
• Neurology
• Medical Devices

Background:

• Transcatheter aortic valve replacement (TAVR) is a key treatment for severe symptomatic aortic stenosis.
• Embolic stroke is a risk during TAVR due to dislodged debris.
• Cerebral embolic protection (CEP) devices aim to mitigate this risk, but their efficacy is debated.

Purpose of the Study:

• To investigate regional variations in the effectiveness of CEP devices in reducing stroke during TAVR.
• To analyze stroke outcomes associated with CEP utilization across different geographic cohorts.

Main Methods:

• Post hoc analysis of the prospective, postmarket, randomized PROTECTED TAVR trial.
• Inclusion of patients undergoing transfemoral TAVR at 51 centers in the US, Europe, and Australia.
• Comparison of stroke rates between TAVR with CEP and TAVR alone, stratified by geographic region (US vs. outside US).

Main Results:

• The overall PROTECTED TAVR trial showed no significant difference in stroke incidence between TAVR with CEP and TAVR alone.
• In a US cohort, TAVR with CEP demonstrated a 50% relative risk reduction in overall stroke and a 73% reduction in disabling stroke.
• No significant stroke risk reduction was observed in the outside US cohort.

Conclusions:

• The PROTECTED TAVR trial did not establish a significant benefit of CEP for periprocedural stroke reduction overall.
• This post hoc analysis suggests potential regional differences, with a trend toward greater stroke reduction in the US cohort.
• Further research is warranted to explore factors influencing CEP efficacy across different patient populations and procedural practices.