Highlight
The PARTNER 3 trial reports no significant differences in a composite endpoint of death, stroke, or rehospitalization between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in low-risk severe aortic stenosis patients at 7 years. Valve durability and patient-reported outcomes remain comparable across interventions.
Study Background
Aortic stenosis (AS) is a progressive valvular disease where narrowing of the aortic valve impairs left ventricular outflow, leading to symptomatic heart failure and increased mortality if untreated. Traditionally, surgical aortic valve replacement has been the gold standard. However, TAVR has become an established alternative, particularly in high- and intermediate-risk patients, offering less invasiveness and faster recovery.
As TAVR gains acceptance in lower-risk patients, assessing long-term outcomes including valve function durability, survival, and quality of life is critical to guide clinical decision-making. Prior 5-year data from the PARTNER 3 trial demonstrated comparable safety and efficacy between TAVR and surgery. Extending follow-up to 7 years provides more definitive evidence on sustained benefits and risks in this patient population.
Study Design
The PARTNER 3 trial is a multicenter, randomized controlled trial enrolling 1,000 low-risk patients with severe, symptomatic aortic stenosis. Patients were randomized 1:1 to receive transfemoral TAVR or SAVR, the current standard surgical approach.
Two primary endpoints were evaluated at 7 years: (1) a nonhierarchical composite of death, stroke, or rehospitalization related to the procedure, valve, or heart failure; and (2) a hierarchical composite analyzed by win ratio including death, disabling stroke, nondisabling stroke, and days rehospitalized. Secondary evaluations included echocardiographic assessment of valve hemodynamics, bioprosthetic valve failure rates, and patient-reported health status.
Key Findings
At 7 years, analysis of the first primary endpoint showed event rates of 34.6% with TAVR versus 37.2% with SAVR, yielding a nonsignificant absolute difference of -2.6 percentage points (95% CI, -9.0 to 3.7), indicating no statistically significant superiority or inferiority between the two modalities. The win ratio for the hierarchical primary endpoint was 1.04 (95% CI, 0.84 to 1.30), again confirming comparable overall clinical outcomes.This reflects comparable long-term risk of death, stroke, or rehospitalization between both strategies.
The win ratio analysis for the second primary endpoint was 1.04 (95% CI, 0.84 to 1.30), indicating no significant superiority for either approach when considering hierarchical clinical events and duration of rehospitalization.
Incidence of individual endpoint components were similar: death occurred in 19.5% (TAVR) versus 16.8% (SAVR), stroke rates were 8.5% versus 8.1%, and rehospitalizations were 20.6% versus 23.5%, respectively. These comparable outcomes further emphasize the equivalence of TAVR and surgery in low-risk patients over long-term follow-up.
Echocardiographically measured mean aortic valve gradients remained low and similar in both groups (13.1 ± 8.5 mm Hg post-TAVR vs. 12.1 ± 6.3 mm Hg post-SAVR) at seven years, underscoring sustained hemodynamic valve performance. The percentage of bioprosthetic valves that met criteria for structural valve deterioration and failure was low and equivalently distributed: 6.9% in TAVR recipients versus 7.3% in surgical valve recipients.
Patient-reported outcomes, including quality of life measures, were consistently alike between groups, signifying equivalent clinical benefit from the patient’s perspective.
Expert Commentary
The PARTNER 3 seven-year data is pivotal in validating TAVR as a long-term viable alternative to surgery for low-risk severe aortic stenosis patients. The similar survival and stroke rates challenge prior concerns about durability and late complications after TAVR in younger or lower-risk populations.
Limitations include the intrinsic trial population carefully selected for low risk and procedural success, which may limit generalizability to more heterogeneous clinical settings. Continued follow-up beyond 7 years will be essential to monitor very late valve durability and complications. Additionally, evolution of TAVR technology and techniques since trial initiation may further improve outcomes.
Clinical guidelines currently incorporate TAVR as a preferred option in selected patients. These extended results support a shift towards individualized valve replacement strategies based on anatomical and patient preferences without compromising long-term safety.
Conclusion
In patients at low surgical risk with severe, symptomatic aortic stenosis, TAVR and surgical valve replacement confer comparable outcomes in mortality, stroke, rehospitalization, and valve durability at seven years. These findings endorse TAVR as a standard therapeutic option, extending the paradigm of minimally invasive treatment to broader patient populations. Ongoing surveillance and real-world data will remain important to refine patient selection and optimize valve replacement strategies.
Funding and ClinicalTrials.gov
This study was funded by Edwards Lifesciences. The PARTNER 3 trial is registered at ClinicalTrials.gov (NCT02675114).
References
Leon MB, Mack MJ, Pibarot P, Hahn RT, Thourani VH, Kodali SH, et al. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. N Engl J Med. 2025 Oct 27. doi: 10.1056/NEJMoa2509766 IF: 78.5 Q1 . Epub ahead of print. PMID: 41144631 IF: 78.5 Q1 .
