STS/ACC TVT Registry: Observational Study Provides Rationale For Further Research on EPD Use in TAVR
Findings from the STS/ACC TVT Registry looking at the use of cerebral embolic protection devices (EPDs) and TAVR outcomes “provide a strong rationale” for ongoing large-scale randomized clinical trials to test whether EPDs provide meaningful clinical benefit, said investigators presenting Oct. 16 during TCT 2020.
The observational study conducted by David J. Cohen, MD, MSc, et al., assessed data from 12,409 patients with EPDs and 110,777 patients with no EPD that underwent transfemoral TAVR between January 2018 and December 2019. The primary endpoint was in-hospital stroke.
Overall findings suggest use of EPDs are generally safe, with no evidence of increased vascular complications, major bleeding or device failure, despite only being used in 28% of hospitals and 13% of patients with marked variation between centers. Cohen and colleagues note that their “prespecified primary analysis using an instrumental variable approach demonstrated no significant reduction in in-hospital or 30-day stroke.” However, they add that the secondary analysis and the confidence interval for the primary analysis suggest a possible modest reduction in stroke with EDPs (~20% RRR, NNT ~300 for major stroke).
Looking ahead, investigators suggest that larger, randomized trials should address the impacts of EDPs on reducing stroke and improving neurocognitive function for patients undergoing TAVR.
Keywords: TCT20, Transcatheter Cardiovascular Therapeutics, Percutaneous Coronary Intervention, Transcatheter Aortic Valve Replacement, Intracranial Embolism
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