TAVR demonstrated similar 7-year rates of stage 2 or 3 structural valve deterioration compared to surgery (7.3% vs 7.6%; HR 0.96; 95% CI 0.59-1.57; P=.88) in low-risk patients.
RCT (n=948)
randomized
Yes
Does balloon-expandable TAVR provide comparable 7-year valve durability compared to surgical aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis?
In low-risk patients with severe aortic stenosis, TAVR and surgery demonstrated comparable and sustained valve durability through 7 years, though TAVR was associated with higher rates of thrombosis-related valve dysfunction.
Hazard Ratio: 0.96 (95% CI 0.59–1.57)
Absolute Event Rate: 7.3% vs 7.6%
p-value: p=.88
Importance: As transcatheter aortic valve replacement (TAVR) is considered for younger and lower-risk populations, the durability of bioprosthetic valves is increasingly important. Limited data exist on long-term (7 years and beyond) valve durability. Objective: To report 7-year valve durability outcomes for low-risk patients with symptomatic severe aortic stenosis treated with TAVR vs surgery. Design, Setting, and Participants: Between March 2016 and October 2017, a total of 1000 patients were enrolled at 71 centers in the US and Canada and randomized to undergo TAVR vs surgery. The patient population for the present analysis consisted of all patients who underwent valve implantation (495 with TAVR and 453 with surgery). The last 7-year follow-up occurred in March 2025. Interventions: Patients were randomized to balloon-expandable TAVR with the SAPIEN 3 valve or surgery with any commercially available valve. Main Outcomes and Measures: The main outcomes of this analysis were stage 2 or 3 bioprosthetic valve dysfunction (BVD) related to structural valve deterioration (SVD), thrombosis, or endocarditis; all-cause bioprosthetic valve failure (BVF); BVF related to SVD; and aortic valve reintervention at 7 years. Analyses are presented as cumulative incidence rates with death as a competing risk. Results: The mean (SD) age of the study population was 73.5 (6.0) years, and 657 participants (69.3%) were male. Of 671 patients who were still alive and enrolled in the study at 7-year follow-up, 537 (80.0%) were available for echocardiographic analysis. Cumulative incidence rates of stage 2 or 3 SVD-related BVD (7.3% vs 7.6%; hazard ratio HR, 0.96; 95% CI, 0.59-1.57; P = .88), all-cause BVF (6.9% vs 7.5%; HR, 0.91; 95% CI, 0.55-1.49; P = .69), SVD-related BVF (3.9% vs 5.3%; HR, 0.72; 95% CI, 0.39-1.36; P = .31), and valve reintervention (6.0% vs 5.5%; HR, 1.09; 95% CI, 0.62-1.90; P = .77) were low and similar for TAVR and surgery, respectively. Stage 2 or 3 thrombosis-related BVD (subclinical and clinical) occurred more frequently with TAVR (5.2% vs 0.9%; HR, 5.52; 95% CI, 1.92-15.85; P < .001), although most events occurred within 3 years and few progressed to BVF. Rates of stage 2 or 3 endocarditis-related BVD were also low and similar (0.4% in the TAVR group vs 0.5% in the surgery group; HR, 0.85; 95% CI, 0.12-6.07; P = .87). The proportion of patients alive and free of all-cause BVF was 73.4% (331/451) with TAVR vs 74.8% (288/385) with surgery (P = .69). Conclusions and Relevance: In this ad hoc analysis of a randomized clinical trial among low-risk patients with symptomatic severe aortic stenosis randomized to TAVR or surgery, both TAVR and surgery demonstrated comparable and sustained valve durability, with low and similar rates of SVD, all-cause BVF, and reintervention through 7 years. These findings may inform discussions of valve replacement strategies. Trial Registration: ClinicalTrials.gov Identifier: NCT02675114.
“For now, the PARTNER 3 trial durability analysis offers reassuring evidence of excellent midterm outcomes in low-risk patients. As TAVR continues to move into younger populations, understanding which durability pathways matter, and in whom, will be key to building effective lifetime valve strateg...”
The 7-year follow-up data from the landmark PARTNER 3 trial provides crucial long-term insights into the durability of TAVR versus surgical aortic valve replacement in low-risk patients. These findings will heavily influence treatment decisions for aortic stenosis.
Ternacle et al. (Wed,) conducted a rct in Symptomatic severe aortic stenosis (n=948). Transcatheter aortic valve replacement (TAVR) vs. Surgery was evaluated on Stage 2 or 3 SVD-related BVD (HR 0.96, 95% CI 0.59-1.57, p=.88). TAVR demonstrated similar 7-year rates of stage 2 or 3 structural valve deterioration compared to surgery (7.3% vs 7.6%; HR 0.96; 95% CI 0.59-1.57; P=.88) in low-risk patients.
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