Abstract Body (Do not enter title and authors here): Background: Previous evidence from randomized controlled trials (RCTs) on cerebral embolic protection (CEP) during transcatheter aortic valve implantation (TAVI) has been inconclusive. The recent PROTECT TAVI trial, the largest RCT to date, offers new data to reassess outcomes. We conducted a comprehensive meta-analysis with trial sequential analysis (TSA) to provide an up-to-date evaluation of the clinical impact of CEP in TAVI patients.
Research question: Does the use of CEP improve clinical outcomes, including all-cause mortality and stroke, in patients undergoing TAVI who are at increased risk for these adverse events?
Methods: A comprehensive search of databases was conducted to identify RCTs. Pairwise meta-analyses were performed using a random-effects model. Moreover, TSA was employed to calculate the required information size and construct monitoring boundaries for statistical significance and futility, assuming a two-sided alpha of 5% and 90% power. All statistical analyses were carried out using R software.
Results: Eight RCTs encompassing a total of 11,666 patients were included, of whom 5,986 received CEP devices and 5,680 did not. Pairwise meta-analysis demonstrated no significant differences between two groups in terms of all-cause mortality (RR: 1.09; 95% CI: 0.75–1.56), all stroke (RR: 0.92; 95% CI: 0.75–1.14), disabling stroke (RR: 0.80; 95% CI: 0.52–1.21), life-threatening or disabling bleeding (RR: 0.95; 95% CI: 0.17–5.32), major vascular complications (RR: 1.22; 95% CI: 0.43–3.45), worsening of the NIHSS score (RR: 1.21; 95% CI: 0.70–2.10), presence of ischemic brain lesions (RR: 1.00; 95% CI: 0.93–1.07), and acute kidney injury (RR: 0.96; 95% CI: 0.39–2.36). However, use of CEP was associated with a statistically significant reduction in the risk of worsening Montreal Cognitive Assessment (MoCA) scores (RR: 0.72; 95% CI: 0.57–0.90; P = 0.01). TSA showed that the cumulative evidence for all stroke, and disabling stroke did not reach the required information size, indicating insufficient evidence to confirm a statistically significant benefit of CEP in reducing these outcomes. However, futility boundary was reached for all-cause mortality.
Conclusion: While CEP did not significantly impact major clinical outcomes, it was associated with improved cognitive preservation. TSA indicated that evidence for reducing all stroke, and disabling stroke remains inconclusive due to insufficient information size. Further high-quality RCTs are warranted.