Boston Presents (PROTECTED TAVR) Trial Results of Sentinel Cerebral Protection System for Aortic Stenosis at TCT 2022, Published in the NEJM
- The (PROTECTED TAVR) clinical trial evaluating the periprocedural stroke reduction & neurologic outcomes of TAVR with/out Sentinel device to provide CEP in 3000 patients with aortic stenosis at 50+ global sites
- The trial failed to meet its 1EPs i.e., the findings revealed a non-significant trend toward a reduced stroke incidence rate, 21% & 60% relative risk reduction in all strokes (2.3% with TAVR and CEP vs 2.9% with TAVR only) & disabling stroke through 72hrs. or time of hospital discharge (0.5% with CEP vs 1.3% without CEP)
- In subgroup analyses, the device consistently reduced the risk of a debilitating stroke in all patient subgroups, incl. age, gender, surgical risk, valve type & history of CV disease
Ref: PRNewswire| Image: Boston
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