The intra-annular Navitor THV demonstrated a similar rate of the primary composite safety endpoint compared to the supra-annular Evolut THV (adjusted OR 0.97) in patients with severe aortic stenosis.
Observational (n=541)
Yes
Does the intra-annular Navitor valve improve safety and efficacy compared to the supra-annular Evolut PRO valve in patients undergoing transcatheter heart valve implantation?
The intra-annular Navitor valve demonstrated a lower risk of moderate or severe paravalvular leak compared to the supra-annular Evolut PRO, with comparable early safety and mid-term mortality.
Effect estimate: OR 0.97 (95% CI 0.50-1.89)
Absolute Event Rate: 10.8% vs 7.7%
p-value: p=0.224
The implantation of the intra-annular Navitor and the supra-annular Evolut PRO was safe, with severe adverse events occurring at similar rates until discharge. The risk of moderate or severe PVL was lower with Navitor; mid-term mortality was comparable in both groups.
Mattig et al. (Wed,) conducted a observational in Severe aortic stenosis (n=541). Intra-annular Navitor THV vs. Supra-annular Evolut THV was evaluated on Primary composite safety endpoint (all-cause mortality, myocardial infarction, disabling stroke, life-threatening bleeding, major vascular complication, or acute kidney injury requiring dialysis until discharge) (OR 0.97, 95% CI 0.50-1.89, p=0.224). The intra-annular Navitor THV demonstrated a similar rate of the primary composite safety endpoint compared to the supra-annular Evolut THV (adjusted OR 0.97) in patients with severe aortic stenosis.