October 18, 2024Circulation Cardiovascular Interventions9 citationsOpen Access
Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients
Key Result
TAVR resulted in comparable rates of all-cause mortality or disabling stroke at 3 years compared with surgery (5.7% vs 8.0%; P=0.241) in low-risk patients <75 years with severe aortic stenosis.
Study Design
Type
RCT (n=703)
Structured PICO
Does supra-annular, self-expanding TAVR reduce all-cause mortality or disabling stroke compared to surgery in low-surgical-risk severe aortic stenosis patients aged <75 years?
P
Population
703 low-surgical-risk patients aged <75 years with severe aortic stenosis (mean age 69.1±4.0 years, STS PROM 1.7±0.6%)
I
Intervention
Supra-annular, self-expanding transcatheter aortic valve replacement (TAVR)
C
Comparator
Surgery (surgical aortic valve replacement)
O
Outcome
Composite of all-cause mortality or disabling stroke at 3 yearscomposite
In low-risk patients under 75 years with severe aortic stenosis, TAVR resulted in comparable 3-year rates of death or disabling stroke but lower rates of disabling stroke and better valve hemodynamics compared to surgery, albeit with higher pacemaker rates.
Main Result
Absolute Event Rate: 5.7% vs 8%
p-value: p=0.241
Abstract
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.