ACC 2025 | TAVI in Low-Risk Patients: 5-Year Outcomes of EVOLUTE LOW RISK

Transcatheter aortic valve implantation (TAVI) is a valid alternative to surgery in low-risk patients with severe aortic stenosis. However, one of its main limitations is the uncertainty regarding its long-term durability, especially in younger or low-risk patients.

While encouraging 3- to 4-year data are available, information beyond that period remains limited.

Researchers conducted a 5-year analysis of the EVOLUTE LOW RISK study. It included 1414 patients with severe aortic stenosis and low surgical risk; of these, 730 were treated with TAVI and the remainder with surgery using a bioprosthetic valve.

The primary endpoint (PEP) for this study was all-cause mortality or disabling stroke at five years.

The average age of the population was 74 years, and 61% of subjects were men. Both groups shared similar baseline characteristics: hypertension in 79% of cases, diabetes in 31% of subjects, coronary artery disease in 27% of patients, and atrial fibrillation in 17% of cases.

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At five years, there were no significant differences in the PEP, with an incidence of 21.8% in the TAVI group vs. 20.7% in the surgical group (hazard ratio [HR]: 1.05; 95% confidence interval [CI]: 0.86–1.29; p=0.64). There were also no differences in all-cause mortality (17.3% for TAVI vs. 16.5% for surgery; HR: 1.04; 95% CI: 0.83–1.31; p=0.74) or in the rate of disabling stroke (4.9% vs. 4.5%; HR: 1.09; 95% CI: 0.69–1.72; p=0.70).

Regarding secondary endpoints, these were the outcomes for TAVI:

• A lower need for hospitalization due to heart failure (8.8% vs. 12.6%; p=0.03).
  
• Less prosthesis-patient mismatch (8.4% vs. 26.8%; p<0.001).
  
• Lower mean transvalvular gradient (11.7 ± 5.7 vs. 13.9 ± 6.3 mmHg; p<0.001).
  
• Greater indexed valve area (1.60 ± 0.40 vs. 1.38 ± 0.34 cm²/m²; p<0.001).

On the other hand, the outcomes for surgery were as follows:

• Lower incidence of moderate or severe aortic regurgitation (0.8% vs. 4.3%; p<0.001).
  
• Less mild aortic regurgitation (4.9% vs. 31.3%; p<0.001).
  
• Lower need for permanent pacemaker implantation (9.1% vs. 23.2%; p<0.001).

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There were no significant differences in the incidence of infective endocarditis, prosthetic valve thrombosis, or reintervention, suggesting comparable durability between both procedures.

Conclusion

Patients with severe aortic stenosis treated with either supra-annular self-expanding TAVI or surgery had similar rates of all-cause mortality and disabling stroke at 5 years. These findings reinforce TAVI as a safe, effective, and durable alternative to surgery, regardless of patient surgical risk.

Original Title: 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients.

Reference: Michael Forrest et al. Circulation, Volumen 151, 2025.