Valvular & structural heart diseaseSecondary analysis
Cerebral Embolic Protection by Geographic Region
- Post hoc analysis of the PROTECTED transcatheter aortic valve replacement (TAVR) randomised trial
- prospective
- postmarket
- multicentre (51 hospitals)
- exploratory post hoc subgroup analysis by geographic region
- Data analysed August to October 2024
Authors' conclusion
Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort.
Study context
- Population
- Patients with symptomatic AS treated with transfemoral TAVR, 51 hospitals in the US, Europe and Australia, 2020–2022US 1833
- Participants
- 3,000 patients
- Comparison
- TAVR with cerebral embolic protection (CEP) vs TAVR alone, by geographic region
- Primary endpoint
- All stroke events
- Follow-up
- Hospital discharge or 72 hours post-TAVR, whichever came first
Primary result
As reported in the abstract
Stroke by geographic region (US vs OUS cohort)
US cohort: CEP vs TAVR alone, relative risk reduction for overall stroke
50%
US cohort: CEP vs TAVR alone, relative risk reduction for disabling stroke
73%
Further findings
Stroke within 72 h after TAVR or before discharge (main trial)
- No significant difference between CEP and control; no interaction by geographic region
Original publication
Cerebral Embolic Protection by Geographic Region. JAMA Cardiol. Published 1 January 2025. doi:10.1001/jamacardio.2024.4278
Summarised from the published abstract; every number is checked against it