Abstract
Background: Transcatheter aortic valve replacement (TAVR) is an established treatment for severe aortic stenosis. Whether diabetes status influences the comparative effectiveness of TAVR versus surgical aortic valve replacement (SAVR) remains uncertain.
Objectives: This meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the relative outcomes of TAVR versus SAVR stratified by the presence or absence of diabetes mellitus.
Methods: We systematically searched CENTRAL, Embase, and PubMed for RCTs comparing TAVR with SAVR. The primary outcome was all-cause mortality or disabling stroke at 1 or 2 years. Data were pooled using a random-effects model, and subgroup analyses were pre-specified based on diabetes status. Treatment effects were reported as risk ratios (RR) with 95% confidence intervals (CIs).
Results: Four RCTs comprising 4,086 patients (TAVR: 2,121; SAVR: 1,965) were included. The overall analysis demonstrated a significant reduction in primary endpoint with TAVR compared to SAVR (RR 0.78, 95% CI 0.64-0.96, P=0.02). Subgroup analysis revealed a non-significant interaction based on diabetes status (P for interaction = 0.61). In patients without diabetes, TAVR was associated with a significant reduction in mortality (RR 0.76, 95% CI 0.59-0.97, P=0.03). In contrast, among patients with diabetes, there was no statistically significant difference between TAVR and SAVR (RR 0.85, 95% CI 0.58-1.25, P=0.41). Heterogeneity was negligible across all analyses (I² = 0%).
Conclusions: In this meta-analysis of RCTs, TAVR was associated with a lower risk of the mortality-inclusive primary endpoint in patients without diabetes, while outcomes were similar between TAVR and SAVR in patients with diabetes. However, there was no significant evidence that diabetes status modified the treatment effect.
