Abstract
Background: Transcatheter aortic valve replacement (TAVR) has become a standard therapy for severe aortic stenosis across the surgical risk spectrum. Diabetes mellitus is a common comorbidity in these patients and is associated with worse outcomes after surgical AVR (SAVR). Whether diabetes status influences the comparative effectiveness of TAVR versus 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, the significant survival benefit of TAVR compared to SAVR was driven entirely by patients without diabetes, whereas patients with diabetes derived no significant survival advantage from either procedure. These findings suggest that diabetes status may be an important effect modifier, warranting consideration in the heart team's decision-making process.
