The Evolut Low Risk trial was a prospective randomized trial that enrolled patients at low surgical risk with severe trileaflet aortic stenosis from 87 international sites between 2016 and 2019. Patients were deemed suitable for either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) and had a predicted surgical mortality risk of ≤3%. A total of 1,414 patients underwent attempted valve implantation with TAVR using a self-expanding supra-annular bioprosthesis or SAVR (730 TAVR; 684 SAVR). Patients were followed annually with independent adjudication of clinical events and planned follow-up through 10 years. The primary composite endpoint of all-cause death or disabling stroke was not different between arms: 23.3% in the TAVR arm versus 20.4% in the SAVR arm (95% confidence interval, -1.9% to 7.6%; p = 0.43). The reintervention analysis used outcomes based on the implanted as opposed to the randomized assignments. Reintervention rates were numerically higher after TAVR at 6 years (5.5% vs. 3.3%) and became significant at 7-year follow-up (9.8% vs. 6%; subdistribution hazard ratio, 1.68; p = 0.02).¹

The higher reintervention rates in the TAVR arm were largely driven by bioprosthetic aortic regurgitation (AR) rather than progressive valve stenosis. In a post hoc subgroup analysis of the TAVR arm, off-guidance postdilation was associated with higher rates of reintervention for AR than were on-guidance or no postdilation. However, this observation should be considered hypothesis generating.

Study limitations include incomplete 7-year data at the time of analysis, use of earlier-generation self-expanding valves and implantation techniques, and heterogeneity in surgical prosthesis selection. Planned 10-year follow-up will provide further information on comparative valve durability and patient outcomes.

References

1. Forrest JK, Yakubov SJ, Deeb GM, Reardon MJ; Evolut Low Risk Trial Investigators. Six-year outcomes after transcatheter vs surgical aortic valve replacement in low-risk patients with aortic stenosis. J Am Coll Cardiol. Published online February 16, 2026. doi:10.1016/j.jacc.2026.02.5063