Transcatheter aortic valve replacement demonstrated significantly lower rates of structural valve deterioration than surgical replacement at 6 years (4.8% vs. 24.0%; P<0.001).
RCT (n=274)
1:1
Yes
Does TAVR improve valve durability compared to SAVR in patients with severe aortic stenosis at lower surgical risk?
In lower-risk patients with severe aortic stenosis, TAVR demonstrated significantly lower rates of structural valve deterioration compared to SAVR at 6 years, with similar rates of overall bioprosthetic valve failure.
Absolute Event Rate: 4.8% vs 24%
p-value: p=<0.001
BACKGROUND Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk. OBJECTIVES The aim of this study was to compare the durability of transcatheter and surgical bioprosthetic aortic valves using standardized criteria. METHODS In the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients with severe aortic stenosis and lower surgical risk for mortality were randomized 1:1 to TAVR (n = 139) or SAVR (n = 135). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months or moderate/severe paravalvular leakage. Bioprosthetic valve failure (BVF) was defined as: valve-related death, aortic valve reintervention, or severe hemodynamic SVD. RESULTS At 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%; p = 0.89). CONCLUSIONS In the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. Longer-term follow-up of randomized clinical trials will be necessary to confirm these findings. (Nordic Aortic Valve Intervention Trial; NCT01057173).
“The data we have on 10-year durability of TAVI are very scarce and what we had before NOTION were just registry-based analyses describing durability of TAVI not compared to surgery, so this is really the first time we see such a long-term outcome assessment from a randomised trial.”
Søndergaard et al. (2019) conducted an RCT in Severe aortic stenosis (n=274). Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR) was evaluated on Moderate/severe structural valve deterioration (SVD) (p=<0.001). Transcatheter aortic valve replacement demonstrated significantly lower rates of structural valve deterioration than surgical replacement at 6 years (4.8% vs. 24.0%; P<0.001).