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10-Year Randomized Outcomes of Transcatheter or Surgical Aortic Valve Replacement in Intermediate-Risk Aortic Stenosis
Key result
TAVR with SAPIEN XT increases 10-year all-cause mortality ~13% versus surgery.
- HR 1.13
- 95% CI 1.02-1.25
- P=0.02
- n=1,910
Why the study?
TAVR is an established alternative to surgery for symptomatic severe aortic stenosis, but long-term comparative clinical outcomes and echocardiography data are lacking.
Does TAVR with the SAPIEN XT system improve 10-year survival and clinical outcomes compared to surgical aortic valve replacement in patients with severe, symptomatic aortic stenosis at intermediate surgical risk?
Key Points
- To compare 10-year clinical and echocardiographic outcomes of TAVR and surgical aortic valve replacement in intermediate-risk patients.
- Randomized trial of 1,910 patients with intermediate-risk symptomatic aortic stenosis at 57 centers.
- Patients received either TAVR with the SAPIEN XT valve or surgical replacement between 2011 and 2013.
- Evaluation of all-cause mortality, aortic valve reintervention, and echocardiographic outcomes at 10 years.
- 10-year all-cause mortality was 86.1% for TAVR and 82.8% for surgery (HR: 1.13; 95% CI: 1.02-1.25; P = 0.02).
- Cumulative incidence of aortic valve reintervention was significantly higher in TAVR patients at 6.3% compared to 1.6% for surgery (P < 0.001).
- Mortality rates in TAVR patients varied significantly by access route, with higher rates in the TA/TAo group (93.2% vs 85.1%; P < 0.01).
Study Design
Type
RCT (n=1,910)
Randomization
Stratified by anatomical suitability for transfemoral or transthoracic access
Multicenter
Yes
Structured PICO
Does TAVR with the SAPIEN XT system improve 10-year survival and clinical outcomes compared to surgical aortic valve replacement in patients with severe, symptomatic aortic stenosis at intermediate surgical risk?
P
Population
1,910 patients with severe, symptomatic aortic stenosis at intermediate surgical risk, followed for 10 years.
I
Intervention
Transcatheter aortic valve replacement (TAVR) with the balloon-expandable SAPIEN XT system via transfemoral (TF) or transthoracic (transapical/transaortic [TA/TAo]) access.
C
Comparator
Surgical aortic valve replacement (surgery).
O
Outcome
10-year outcomes including all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes.hard clinical
Main Result
Hazard Ratio: 1.13 (95% CI 1.02–1.25)
Absolute Event Rate: 86.1% vs 82.8%
p-value: p=0.02
At 10 years, TAVR with the early-generation SAPIEN XT valve in intermediate-risk patients was associated with higher reintervention rates and lower survival compared to surgery, though mortality differences were driven by the non-transfemoral access cohort.
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.”
DMDr. Michael A. BorgerCardiovascular Surgeon
“The heart valve companies have told us as surgeons for decades now, 'Don't touch the valve leaflets,' because that can impact long-term durability. They know this from their pulse duplicators and other preclinical information. And yet we are crimping these valves, we are using balloons to expand them, and sometimes we even use larger balloons to overexpand these valves. This is not biomechanically surprising to see that this may have some impact on long-term durability.”
“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
May favor surgery over early-generation TAVR for 10-year survival in intermediate-risk patients; challenges assumptions of long-term equivalence.
Abstract
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an established alternative to surgical aortic valve replacement for symptomatic severe aortic stenosis, but long-term, comparative clinical outcomes and echocardiography data are lacking. OBJECTIVES: Our goal was to compare 10-year clinical and echocardiographic outcomes after balloon-expandable TAVR or surgery in intermediate-risk surgical patients in the PARTNER 2A randomized trial. METHODS: Between 2011 and 2013, patients with severe, symptomatic aortic stenosis at intermediate surgical risk were randomized at 57 centers to TAVR with the balloon-expandable SAPIEN XT system (Edwards Lifesciences) or to surgery. Randomization was stratified by anatomical suitability for transfemoral (TF) or transthoracic (transapical/transaortic [TA/TAo]) access. Ten-year outcomes were evaluated in the valve implant population and included all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes. To obtain 10-year data, patient reconsent at 5 years was required, and vital status sweeps were implemented to improve data completeness for all-cause mortality. RESULTS: Among 1,910 randomized patients who received a valve, 974 underwent TAVR (TF: 749/974 [76.9%]) and 936 had surgery. Mean patient age was 81.6 years, 45.4% were women, and the mean Society of Thoracic Surgeons score was 5.8%. At 10 years, vital status was available for 881 of 974 patients (90.5%) and 838 of 936 patients (89.5%). All-cause 10-year mortality with vital status sweeps was 86.1% after TAVR and 82.8% after surgery (HR: 1.13; 95% CI: 1.02-1.25; P = 0.02). When stratified by access route, rates of all-cause mortality for TAVR and surgery in the TF group were similar (83.9% vs 82.1%, respectively; P = 0.27), whereas mortality was higher for TAVR in the TA/TAo group (93.2% vs 85.1%; P < 0.01; P for interaction = 0.03). Cumulative incidence rates of aortic valve reintervention at 10 years were 6.3% for TAVR and 1.6% for surgery (P < 0.001). Of the 24 TAVR and 35 surgical patients with available echocardiographic data at 10 years, mean gradients were 12.6 mm Hg and 12.7 mm Hg, respectively. CONCLUSIONS: At the 10-year follow-up, TAVR in intermediate-risk patients with the SAPIEN XT prosthesis compared with surgery was associated with lower survival rates, with differences predominantly observed in the TA/TAo access cohort. TAVR with the XT valve was also associated with significantly higher rates of aortic valve reintervention. (PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk [PII A]; NCT01314313).
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
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Cite This Study
Thourani et al. (2026) conducted an RCT in Symptomatic severe aortic stenosis (n=1,910). Transcatheter aortic valve replacement (TAVR) with the balloon-expandable SAPIEN XT system vs. Surgical aortic valve replacement was evaluated on All-cause mortality (HR 1.13, 95% CI 1.02-1.25, p=0.02). Transcatheter aortic valve replacement with the SAPIEN XT prosthesis was associated with higher 10-year all-cause mortality compared to surgery (86.1% vs 82.8%; HR 1.13; 95% CI 1.02-1.25; P=0.02).