Key result
TAVR matches surgery for 3-year mortality and disabling stroke in younger low-risk patients.
Why the study?
TAVR is an alternative to surgery in severe aortic stenosis, but data are limited on younger, low-risk patients.
Does transcatheter aortic valve replacement (TAVR) improve the composite of all-cause mortality or disabling stroke compared to surgical aortic valve replacement in patients <75 years with low-surgical-risk severe aortic stenosis?
RCT (n=703)
1:1
Yes
Does transcatheter aortic valve replacement (TAVR) improve the composite of all-cause mortality or disabling stroke compared to surgical aortic valve replacement in patients <75 years with low-surgical-risk severe aortic stenosis?
In low-risk patients <75 years with severe aortic stenosis, TAVR demonstrated comparable 3-year rates of all-cause mortality or disabling stroke compared to surgery, with better valve hemodynamics but higher pacemaker rates.
Answers are grounded in this paper and cite their sources.
Supports TAVR as alternative in low-risk patients under 75; extends randomized evidence to younger cohorts.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery. METHODS: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years. RESULTS: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery ( P =0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P =0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P <0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P =0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients ( P <0.001) and lower rates of severe prosthesis-patient mismatch ( P <0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation. CONCLUSIONS: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR. REGISTRATION: URL: https://clinicaltrials.gov ; Unique identifier: NCT02701283.
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Modine et al. (2024) conducted an RCT in Severe, symptomatic aortic stenosis at low surgical risk (n=703). Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (surgery) was evaluated on Composite of all-cause mortality or disabling stroke at 3 years (p=0.241).
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