Seven-year follow-up data from the PARTNER 3 trial shows no significant difference in key outcomes between transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement (SAVR) for low-risk patients with severe, symptomatic aortic stenosis.¹ This long-term assessment provides further insight into valve durability and clinical outcomes, building on previous 5-year data which also showed similar results.
Methodology
The PARTNER 3 trial (NCT02675114) was a randomised controlled trial that enrolled 1,000 low-risk patients with severe, symptomatic aortic stenosis. Patients were assigned in a 1:1 ratio to undergo either transfemoral TAVR or surgery.
The first primary endpoint was a nonhierarchical composite of death, stroke, or rehospitalisation related to the procedure, valve, or heart failure. The second primary endpoint was a hierarchical composite analysing death, disabling stroke, nondisabling stroke, and the number of rehospitalisation days, evaluated using a win ratio analysis. Researchers assessed clinical, echocardiographic, valve-durability, and health-status endpoints through 7 years.
Results
At the 7-year mark, the analysis of the first primary endpoint revealed a Kaplan–Meier estimated incidence of 34.6% in the TAVR group and 37.2% in the surgery group (difference, −2.6 percentage points; 95% CI, −9.0 to 3.7). For the second primary endpoint, the win ratio was 1.04 (95% CI, 0.84 to 1.30), also indicating no significant difference between the two procedures.
When examining the individual components of the first primary endpoint, the Kaplan–Meier estimates for the TAVR and surgery groups were, respectively: death (19.5% vs 16.8%), stroke (8.5% vs 8.1%), and rehospitalisation (20.6% vs 23.5%).
Echocardiographic assessment at 7 years found mean aortic-valve gradients of 13.1±8.5mmHg after TAVR and 12.1±6.3 mmHg after surgery. The rate of bioprosthetic valve failure was also similar between the groups, at 6.9% for TAVR and 7.5% for surgery. Patient-reported outcomes were comparable in both arms of the study.
In Practice
These 7 year findings from the PARTNER 3 trial demonstrate that among low-risk patients with severe, symptomatic aortic stenosis, TAVR and SAVR have comparable outcomes with respect to the primary composite endpoints of death, stroke, and rehospitalisation. The data on valve durability and patient-reported outcomes further support the equivalence of the two approaches in this patient population over a longer-term follow-up period.
This study was funded by Edwards Lifesciences.
References
1. Leon MB, Mack MJ, Pibarot P, et al. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. N Engl J Med 2026;394:773-783. https://doi.org/10.1056/NEJMoa2509766
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