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10-Year Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement or Surgery in Intermediate-Risk Patients
Key result
TAVR shows similar 10-year all-cause mortality to surgery in intermediate-risk patients.
- HR 1.01
- 95% CI 0.91-1.13
- P=0.82
- n=2,005
Why the study?
Long-term outcomes data are lacking for TAVR in intermediate-risk patients with symptomatic severe aortic stenosis, particularly with newer-generation transcatheter heart valves.
Does TAVR with the SAPIEN 3 valve result in similar 10-year all-cause mortality and reintervention rates compared to surgery in intermediate-risk patients with symptomatic severe aortic stenosis?
Key Points
- This study aims to compare the 10-year outcomes of TAVR using the SAPIEN 3 valve with surgical aortic valve replacement in intermediate-risk patients.
- Intermediate-risk patients were enrolled in the PARTNER 2A trial and PARTNER 2 SAPIEN 3 Intermediate-risk Registry.
- Propensity score matching was used to balance baseline characteristics between TAVR and surgical groups.
- Ten-year outcomes included all-cause mortality, aortic valve reintervention, and echocardiographic metrics.
- At 10 years, all-cause mortality was 83.4% for TAVR and 82.3% for surgery (HR: 1.01, 95% CI: 0.91-1.13; P=0.82).
- Aortic valve reintervention rates were 2.0% for TAVR and 1.9% for surgery (P=0.47).
- Mean echocardiographic gradients were similar at 11.0 mm Hg for TAVR and 12.6 mm Hg for surgery.
Study Design
Type
Cohort (n=2,005)
Multicenter
Yes
Structured PICO
Does TAVR with the SAPIEN 3 valve result in similar 10-year all-cause mortality and reintervention rates compared to surgery in intermediate-risk patients with symptomatic severe aortic stenosis?
P
Population
2,005 intermediate-risk patients with symptomatic severe aortic stenosis (mean age 82 years, 43% female) followed for 10 years after TAVR or surgery.
E
Exposure
Transcatheter aortic valve replacement (TAVR) with the third-generation, balloon-expandable SAPIEN 3 valve
C
Comparator
Surgical aortic valve replacement (from the PARTNER 2A randomized trial), propensity score-matched 1:1 to account for baseline differences
O
Outcome
All-cause mortality at 10 yearshard clinical
Main Result
Hazard Ratio: 1.01 (95% CI 0.91–1.13)
Absolute Event Rate: 83.4% vs 82.3%
p-value: p=0.82
At 10 years, TAVR with the SAPIEN 3 valve demonstrates comparable all-cause mortality, reintervention rates, and hemodynamics to surgical aortic valve replacement in intermediate-risk patients with severe aortic stenosis.
Limitations
- differential loss to follow-up
- competing risk of mortality in elderly populations
- Differential loss to follow-up
- Competing risk of mortality in elderly populations
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Taken together, the studies show a likely early advantage of TAVR with respect to the important primary clinical endpoints, with a later catch-up of surgery, such that there are no major differences between the therapies at 5 years. However, we know that 6 to 10 years and beyond is really the test of time for these valves, and that’s where we’re starting to see some differences emerge.”
“It is important to contextualize these 10-year findings. The elevated paravalvular regurgitation and reintervention rates likely reflect, at least in part, limitations of the Sapien XT device and the absence of routine CT-based sizing at the time of the study. Both aspects have evolved substantially in contemporary practice with current-generation THV [transcatheter heart valve] platforms and the adoption of systematic CT-based procedural planning.”
Implication
Supports TAVR durability in intermediate-risk patients; extends PARTNER 2 follow-up yet leaves open need for randomized confirmation.
Abstract
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement for patients with symptomatic severe aortic stenosis. However, long-term outcomes data are lacking for TAVR, particularly with newer-generation transcatheter heart valves. OBJECTIVES: The purpose of this study was to compare 10-year outcomes of intermediate-risk patients who underwent TAVR with the third-generation, balloon-expandable SAPIEN 3 valve in the PARTNER 2 SAPIEN 3 Intermediate-risk Registry (P2S3i) with those who underwent surgery in the PARTNER 2A (P2A) randomized trial. METHODS: Intermediate-risk patients were enrolled in the P2A trial from 2011 through 2013 and in the P2S3i registry in 2014. These prospective, multicenter studies used the same eligibility criteria and stratified patients based on suitability for transfemoral or transthoracic (transapical/transaortic) access. Ten-year outcomes were evaluated, including all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes. Patient reconsent was required at 5 years for extended 10-year follow-up, and vital status sweeps were implemented to improve data completeness for all-cause mortality. To account for potential baseline differences and reduce confounding, P2S3i TAVR patients were propensity score-matched 1:1 to P2A surgical patients. RESULTS: Among 2,005 patients who received a valve, 1,069 underwent TAVR in P2S3i and 936 underwent surgery in P2A. After propensity score matching (N = 783 patients in each group), baseline characteristics were similar between groups: mean age was approximately 82 years, 43% were female, and mean Society of Thoracic Surgeons score was 5.5%. At 10 years, all-cause mortality rate was 83.4% after TAVR and 82.3% after surgery, respectively (HR: 1.01 [95% CI: 0.91-1.13]; P = 0.82). Aortic valve reintervention rates adjusted for competing mortality were 2.0% for TAVR and 1.9% for surgery (P = 0.47). Among 32 TAVR and 30 surgical patients with available echocardiographic data at 10 years, mean gradients were 11.0 mm Hg and 12.6 mm Hg, respectively. CONCLUSIONS: At 10 years, TAVR with the SAPIEN 3 valve and surgery resulted in similar rates of mortality and aortic valve reintervention, and similar hemodynamics in intermediate-risk patients with symptomatic severe aortic stenosis. This analysis highlights challenges associated with extended long-term follow-up of clinical trials, including differential loss to follow-up and the competing risk of mortality in elderly populations. (PARTNER 2A Trial; NCT01314313; PARTNER 2 SAPIEN 3 Intermediate-Risk Registry; NCT03222128).
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
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Cite This Study
Nazif et al. (2026) conducted a cohort in symptomatic severe aortic stenosis (n=2,005). TAVR with the SAPIEN 3 valve vs. Surgical aortic valve replacement was evaluated on all-cause mortality (HR 1.01, 95% CI 0.91-1.13, p=0.82). TAVR with the SAPIEN 3 valve resulted in similar 10-year all-cause mortality compared to surgery in intermediate-risk patients (83.4% vs 82.3%; HR 1.01; 95% CI 0.91-1.13; P=0.82).