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| Turkish Society of Cardiology Young Cardiologists Bulletin Year: 8 Number: 3 / 2025 |
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Prepared by: Dr. Sefa Sarı Name of the Study: Meta-Analysis of Individual Patient Data from the PROTECTED TAVR and BHF PROTECT-TAVI TrialsPublished in Congress: EuroPCR 2025 Link: https://www.pcronline.com/Courses/EuroPCR Introduction Transcatheter aortic valve replacement (TAVR) has been used frequently in patients with advanced aortic stenosis in recent years. Debris that breaks off during this procedure can lead to stroke. Systemic embolic protection (CEP) devices may prevent embolization by catching these debris. However, data from studies are inconclusive on the benefit of CEP use. Recent studies such as PROTECTED TAVR and BHF PROTECT-TAVI showed no significant difference between the CEP arm and the control arm within 72 hours after TAVR. ObjectiveThe aim of the meta-analysis was to combine the results of the two studies in order to gain a better understanding of them, and to pave the way for further studies that would demonstrate the certainty of the benefits of using CEP. MethodsThis meta-analysis combined individual patient data (IPD) from 10,635 patients from the PROTECTED TAVR (n=3,000) and BHF PROTECT-TAVI (n=7,635) studies. The SENTINEL™ device (Boston Scientific) was used as the device. In the study, patients were divided into 2 groups: CEP users (n= 5287) and non-users (n=5293). Patient populations in both arms were similar. The primary endpoint was the difference in the incidence of stroke within 72 hours after the procedure in both arms. ResultsThe combined results failed to show evidence that a routine CEP strategy is effective in reducing overall stroke. ConclusionsThis meta-analysis confirmed that there was no reduction in periprocedural stroke after TAVR with the use of CEP. CommentaryAlthough the argument for CEP use is clear, a meta-analysis of individual data from 2 large randomized controlled trials (PROTECTED TAVR and BHF-PROTECT-TAVI) clearly showed that routine CEP use with the SENTINEL device during TAVR had no benefit in reducing the risk of peri-procedural stroke. This meta-analysis sheds light on some points for future studies. Better understanding of the clinical implications of incomplete CEP device placement during the procedure, identification of patient subgroups in whom CEP may be beneficial, and development of a risk prediction model to identify patients at high risk of stroke after TAVR would be useful in reducing the incidence of ischemic stroke after TAVR.
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