RASi therapy post-TAVR in patients with LVEF ≥40% led to a greater reduction in LV mass index compared with standard care (adjusted mean difference -12.77 g/m²; 95% CI -24.73 to -0.81; p=0.036).
RCT (n=200)
Open-label, blinded-endpoint
1:1
Yes
Does the addition of renin-angiotensin system inhibitors to standard care improve left ventricular mass regression in patients aged ≥60 years with symptomatic severe aortic stenosis, LVEF ≥40%, and successful TAVR?
In patients with heart failure and LVEF ≥40% following TAVR, adding renin-angiotensin system inhibitors to standard care significantly enhances reverse left ventricular remodeling and mass regression at 12 months.
Effect estimate: adjusted mean difference -12.77 g/m² (95% CI -24.73 to -0.81)
p-value: p=0.036
Background Residual left ventricular (LV) hypertrophy and incomplete reverse remodelling after transcatheter aortic valve replacement (TAVR) are associated with adverse outcomes. Whether renin-angiotensin system inhibitors (RASi) promote reverse remodelling in patients with heart failure and LV ejection fraction (LVEF) ≥40% following TAVR remains uncertain. Methods In this multicentre, prospective, randomised, open-label, blinded-endpoint trial, patients aged ≥60 years with symptomatic severe aortic stenosis, LVEF ≥40% and successful TAVR were randomly assigned (1:1) to standard care alone or standard care plus RASi (ACE inhibitor, angiotensin II receptor blocker or angiotensin receptor-neprilysin inhibitor). The primary endpoint was change in LV mass index (LVMI) at 12 months. Secondary endpoints included changes in LV volumes, LVEF, N-terminal pro-B-type natriuretic peptide (NT-proBNP) and functional status. Results A total of 200 patients were randomised; 194 were included in the modified intention-to-treat analysis (RASi n=95; control n=99). At 12 months, RASi therapy was associated with a greater reduction in LVMI compared with control (adjusted mean difference −12.77 g/m², 95% CI −24.73 to −0.81; p=0.036). Consistent improvements were observed in LV end-diastolic and end-systolic volumes. Functional status (New York Heart Association class) improved modestly in the RASi group. No significant differences were observed in LVEF or NT-proBNP. Conclusion In patients with heart failure and LVEF ≥40% following TAVR, RAS inhibition led to enhanced reverse LV remodelling over 12 months, reflected by greater regression of LV mass and volumes. These findings support the potential role for RASi in modifying post-TAVR myocardial remodelling, although larger trials are required to determine whether these structural benefits translate into improved clinical outcomes. Trial registration number ChiCTR2100042266.
Shao et al. (Thu,) conducted a rct in Symptomatic severe aortic stenosis post-TAVR with LVEF ≥40% (n=200). Renin-angiotensin system inhibitors (RASi) vs. Standard care alone was evaluated on Change in LV mass index (LVMI) at 12 months (adjusted mean difference -12.77 g/m², 95% CI -24.73 to -0.81, p=0.036). RASi therapy post-TAVR in patients with LVEF ≥40% led to a greater reduction in LV mass index compared with standard care (adjusted mean difference -12.77 g/m²; 95% CI -24.73 to -0.81; p=0.036).