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).
RCT (n=1,910)
Stratified by anatomical suitability for transfemoral or transthoracic access
Yes
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?
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.
Hazard Ratio: 1.13 (95% CI 1.02–1.25)
Absolute Event Rate: 86.1% vs 82.8%
p-value: p=0.02
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).
“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.”
This report on the 10-year outcomes of the PARTNER 2A trial found higher rates of mortality and reintervention with the second-generation SAPIEN XT TAVR compared to surgery in intermediate-risk patients, providing crucial long-term data that will influence patient selection and discussions about valve durability.
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).