TCT ’22: Boston Scientific Shares Sentinel Late-Breaking Trial Data

Boston Scientific announced results from its 3,000-patient PROTECTED TAVR clinical trial evaluating the Sentinel Cerebral Protection System at this year’s Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.
 
Sentinel captures and removes embolic debris stemming from transcatheter aortic valve replacement (TAVR) before it reaches the brain and potentially cause a stroke. The trial assessed periprocedural stroke reduction and neurologic outcomes in aortic stenosis patients treated either with Sentinel for cerebral embolic protection (CEP) during TAVR or TAVR alone.
 
The primary endpoint wasn’t met because data showed a “non-significant” trend toward lower stroke rates in Sentinel patients, with 21% relative risk reduction in all stroke through 72 hours of hospital discharge (2.3% with TAVR and CEP vs. 2.9% with TAVR only, P=0.30).
 
Secondary analysis showed “statistically significant” 60% relative disabling stroke risk reduction through 72 hours or time of discharge in those treated with Sentinel (0.5% with TAVR and CEP vs. 1.3% with TAVR only, P=0.02).
 
“Data from the PROTECTED TAVR trial provide the physician community with evidence that the device plays an important role in reducing disabling strokes across patient types in those undergoing TAVR,” Dr. Samir Kapadia, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute, Cleveland Clinic, told the press. “We also found that the rate of vascular complications in this trial was very low, whether or not the device was used, highlighting the safety of this technology in TAVR procedures.”
 
“Considering strokes are unpredictable, can occur regardless of an individual’s clinical background and often take a great toll on a patient’s quality-of-life and financial stability, we believe the data appear to demonstrate a consistent effect from CEP technology across all patient populations in the trial—supporting the use of the SENTINEL device as an effective therapy to reduce the risk of the most debilitating form of stroke for patients undergoing TAVR,” said Dr. Ian Meredith, global chief medical officer, Boston Scientific. “We look forward to additional data on this technology such as from the currently enrolling PROTECT TAVI trial in the United Kingdom, which will similarly evaluate TAVR-related stroke reduction using the SENTINEL device.”
 
Past clinical trials with over 3,500 patients showed Sentinel is safe and effective, capturing and removing cerebral embolic debris in 99% of TAVR cases.¹
 
Reference
¹ SENTINEL IDE Trial. Data presented at SENTINEL FDA Advisory Panel, February 23, 2017.