October 27, 2025New England Journal of Medicine
Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years
Key result
TAVR and surgery showed no significant differences in the composite of death, stroke, and rehospitalization at 7 years in low-risk patients with severe aortic stenosis.
Why the study?
Does transfemoral transcatheter aortic-valve replacement (TAVR) improve outcomes compared to surgical aortic-valve replacement in low-risk patients with severe, symptomatic aortic stenosis?
Key Points
- To evaluate the 7-year clinical outcomes, echocardiographic performance, and valve durability of transcatheter versus surgical aortic-valve replacement in low-risk patients with severe, symptomatic aortic stenosis.
- In the multicenter PARTNER 3 randomized trial (NCT02675114), 1000 low-risk patients with severe, symptomatic aortic stenosis were randomly assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic-valve replacement (TAVR) or surgical aortic-valve replacement.
- The first primary end point was a nonhierarchical composite of death, stroke, or procedure-, valve-, or heart-failure-related rehospitalization; the second was a hierarchical composite analyzed by win ratio; outcomes were tracked through 7 years.
- The 7-year Kaplan-Meier incidence of the first primary composite end point was 34.6% with TAVR versus 37.2% with surgery (difference, -2.6 percentage points; 95% CI, -9.0 to 3.7), while the win ratio for the hierarchical second primary end point was 1.04 (95% CI, 0.84 to 1.30).
- Individual 7-year event rates for TAVR versus surgery were 19.5% versus 16.8% for death, 8.5% versus 8.1% for stroke, and 20.6% versus 23.5% for rehospitalization.
- At 7 years, echocardiographic mean aortic-valve gradients were 13.1±8.5 mm Hg after TAVR versus 12.1±6.3 mm Hg after surgery, with bioprosthetic valve failure occurring in 6.9% and 7.5% of patients, respectively.
Structured PICO
Does transfemoral transcatheter aortic-valve replacement (TAVR) improve outcomes compared to surgical aortic-valve replacement in low-risk patients with severe, symptomatic aortic stenosis?
P
Population
1000 low-risk patients with severe, symptomatic aortic stenosis
I
Intervention
Transfemoral transcatheter aortic-valve replacement (TAVR)
C
Comparator
Surgical aortic-valve replacement
O
Outcome
First primary end point: nonhierarchical composite of death, stroke, or rehospitalization related to the procedure, the valve, or heart failure at 7 years. Second primary end point: hierarchical composite of death, disabling stroke, nondisabling stroke, and the number of rehospitalization days related to the procedure, the valve, or heart failure at 7 years.composite
In low-risk patients with severe aortic stenosis, TAVR and surgical aortic-valve replacement showed no significant difference in the composite of death, stroke, or rehospitalization at 7 years of follow-up.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“As TAVR is increasingly performed in younger patients with longer life expectancy, understanding long-term transcatheter and surgical valve durability is essential to inform patient-centered decision making. Having this extended clinical and echocardiographic follow-up shows that TAVR is a safe and effective option for this low-risk population.”
“What is very clear is that... TAVR won the first year, no question about it, but surgery wins after that. There is catch-up occurring with surgery so that by 7 years, they are roughly equal in all components.”
“A consistent finding in PARTNER 3 follow-up analyses has been an attenuation of the between-group difference in primary endpoint events, which favors TAVR over surgery in the first year with no between-group differences apparent during longer follow-up.”
Implication
Informs patient-centered TAVR choice in low-risk severe AS; extends RCT evidence to 7 years.
Abstract
BACKGROUND: Five-year data from the PARTNER 3 trial showed that among low-risk patients with severe, symptomatic aortic stenosis, outcomes were similar among patients who had undergone transcatheter aortic-valve replacement (TAVR) and those who had undergone surgical aortic-valve replacement. Longer-term assessments of clinical outcomes and valve durability are needed. METHODS: Patients were randomly assigned in a 1:1 ratio to undergo transfemoral TAVR or surgery. The first primary end point was a nonhierarchical composite of death, stroke, or rehospitalization related to the procedure, the valve, or heart failure. The second primary end point was a hierarchical composite of death, disabling stroke, nondisabling stroke, and the number of rehospitalization days related to the procedure, the valve, or heart failure, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, valve-durability, and health-status end points were assessed through 7 years. RESULTS: A total of 1000 patients underwent randomization. In the analysis of the first primary end point, the Kaplan-Meier estimate of the incidence of an end-point event was 34.6% with TAVR and 37.2% with surgery (difference, -2.6 percentage points; 95% confidence interval [CI], -9.0 to 3.7). The win ratio for the second primary end point was 1.04 (95% CI, 0.84 to 1.30). In the TAVR and surgery groups, respectively, the Kaplan-Meier estimates for the incidence of components of the first primary end point were as follows: death, 19.5% and 16.8%; stroke, 8.5% and 8.1%; and rehospitalization, 20.6% and 23.5%. The mean (±SD) aortic-valve gradients assessed by echocardiography at 7 years were 13.1±8.5 mm Hg after TAVR and 12.1±6.3 mm Hg after surgery. The percentage of bioprosthetic valves that failed was 6.9% in the TAVR group and 7.5% in the surgery group. Patient-reported outcomes were similar in the two groups. CONCLUSIONS: Among low-risk patients with severe, symptomatic aortic stenosis, no significant differences with respect to two primary composite end points involving death, stroke, and rehospitalization were observed at 7 years between those who had undergone TAVR and those who had undergone surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).
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Cite This Study
Leon et al. (2025) studied this question. TAVR and surgery showed no significant differences in the composite of death, stroke, and rehospitalization at 7 years in low-risk patients with severe aortic stenosis.