Why is this study important?

• Transcatheter aortic valve replacement (TAVR) is a common and effective treatment for patients with severe aortic stenosis.  
• Procedure-related stroke is unpredictable and complicates 2-4% of TAVR procedures. 
• Cerebral embolic protection (CEP) devices are available and approved for use in TAVR procedures but have not yet been shown to be effective in reducing procedure-related strokes. 
• The PROTECTED TAVR trial showed no evidence of stroke reduction at 72 hours with the routine use of the Sentinel (Boston Scientific) CEP device, the most widely available device. However, disabling strokes occurred in fewer patients in the treatment group, thus leaving open the possibility of benefit. Further study was recommended. 

What question was this study supposed to answer?

• The BHF PROTECT-TAVI trial is a UK-based randomized trial conducted to evaluate whether routine use of Sentinel CEP in TAVR procedures would reduce the incidence of clinical stroke. 
• The trial's primary endpoint was stroke (defined as a neurological deficit of vascular origin occurring after randomization and lasting >24 hours or led to death within 24 hours) at 72 hours post-TAVR or by discharge if this occurred sooner than 72 hours.  
• Secondarily, the trial evaluated rates of death from any cause, a composite of death from any cause or stroke, or transient ischemic attack (TIA), and vascular access site complications according to VARC-2 criteria. 

What did the study show?

• A total of 7,635 patients were randomized in a 1:1 fashion to standard TAVR procedure or TAVR with a Sentinel CEP device. This represented approximately 30% of all TAVR procedures performed in the UK during the study period. 
• Baseline and procedural characteristics were similar between the two study arms. The average patient age was 81 years, with 39% female participation.  
• The trial was stopped after the planned third interim analysis due to futility.  
• No difference in the primary outcome of stroke at 72 hours was noted between the control group (2.2%) and the treatment group (2.1%), p=0.94. There was also no difference in disabling strokes between the two groups, 1.4% and 1.2%, respectively, p=0.55. Therefore, the routine use of Sentinel CEP does not reduce stroke during TAVR. 
• No significant difference was observed in any of the secondary endpoints between the control group and the Sentinel CEP treatment group.