Why is this study important?
- PROTECTED TAVR, the first large randomized controlled trial of cerebral embolic protection in TAVR, failed to demonstrate that the Sentinel cerebral embolic protection device could reduce the overall incidence of TAVR-related stroke.
- However, the trial did suggest a potential reduction in disabling stroke.
What question was this study supposed to answer?
- Stroke is an important complication of TAVR. It is thought to be primarily due to embolized debris during valve implantation.
- The Sentinel cerebral embolic protection device has been shown to capture embolized debris released during TAVR.
- Small, randomized studies and large observational trials have shown mixed results regarding the ability of Sentinel to prevent clinical strokes.
What did the study show?
- 3,000 patients were randomized to TAVR with or without the Sentinel cerebral embolic protection device.
- The trial was designed for 90% power to detect 50% reduction in stroke, assuming a stroke rate of 4%.
- The Sentinel device was successfully deployed in 94.4% of patients.
- The primary endpoint of strokes at discharge/72 hours did not differ between the Sentinel and the control group (2.3% vs 2.9%, p = 0.30; -0.6%, 95% CI -1.7 % to 0.5%).
- The secondary endpoint of disabling stroke was reduced in the Sentinel group compared to the control group:
- 0.5% (8 of 1,501 patients) in the CEP group and in 1.3% of patients (20 of 1,499 patients) in the control group (difference, −0.8 percentage points; 95% CI, −1.5 to −0.1).
- The number to treat to prevent a disabling stroke was 125.
- Based on the lack of “adjustment for multiple comparisons of secondary end points”, the authors wrote that this finding “should not be used to infer definitive treatment effects.”
- In a multivariable analysis, female sex was associated with stroke (odds ratio, 1.93; 95% CI, 1.20 to 3.12), and use of a balloon-expandable valve was inversely associated with stroke (odds ratio, 0.46; 95% CI, 0.28 to 0.76)
- The incidence of vascular complications at the Sentinel access site was 0.1%, with no other adverse safety signals.
- The larger (8,000 patient) ongoing British Heart Foundation PROTECT TAVI trial should provide additional important data regarding the role of cerebral embolic protection during TAVR.
All editors: Kreton Mavromatis, MD, FSCAI
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