Key result
TAVR versus SAVR trial in small annuli terminates prematurely without reporting primary efficacy outcomes.
Why the study?
The optimal treatment for patients with severe aortic stenosis and small aortic annulus remains to be determined.
Does TAVR reduce impaired valve hemodynamics compared to SAVR in patients with severe aortic stenosis and small aortic annulus?
RCT (n=151)
Open-label
1:1
Yes
Does TAVR reduce impaired valve hemodynamics compared to SAVR in patients with severe aortic stenosis and small aortic annulus?
BACKGROUND The optimal treatment in patients with severe aortic stenosis (AS) and small aortic annulus (SAA) remains to be determined. The objectives of this study were to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA. METHODS Prospective multicenter international randomized trial performed in 15 university hospitals. Participants were 151 patients with severe AS and SAA (mean diameter <23 mm) were randomized (1:1) to TAVR (n=77) vs SAVR (n=74), The primary outcome was impaired valve hemodynamics (i.e. severe prosthesis patient mismatch [PPM] or moderate-severe aortic regurgitation [AR]) at 60 days as evaluated by Doppler-echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes. RESULTS The mean age of the participants was 75±5 years, with 93 of women, a median STS of 2.5 (1.7-3.3)%, and a mean annulus diameter of 21.1±1.2 mm. CONCLUSIONS This trial will provide clinicians with scientific evidence to determine if population with smaller aortic anatomy in the setting of severe AS maybe better suited to TAVR compared with SAVR. TRIAL REGISTRATION Clinicaltrials.gov : NCT03383445
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Rodés‐Cabau et al. (2023) conducted an RCT in Severe aortic stenosis and small aortic annulus (n=151). Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR) was evaluated on Impaired valve hemodynamics (severe prosthesis-patient mismatch and/or moderate-severe aortic regurgitation) at 60 days. The VIVA trial randomized 151 patients with severe aortic stenosis and small aortic annuli to TAVR or SAVR, but was prematurely terminated and did not report primary efficacy outcomes in the provided text.
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