(VP118) TRANSCATHETER VERSUS SURGICAL AORTIC VALVE REPLACEMENT IN AORTIC STENOSIS PATIENTS AT LOW SURGICAL RISK: 3-YEAR OUTCOMES FROM THE EVOLUT LOW RISK TRIAL

Background: With an increasing number of younger, low risk patients undergoing transcatheter aortic valve replacement (TAVR), understanding mid-term (>2 year) outcomes with TAVR vs surgical AVR (SAVR) is of critical importance for informed decision making by patients and physicians. All patients in the randomized Evolut Low Risk trial of TAVR vs SAVR have now completed 3-year follow-up and herein we report the first randomized data for low risk patients at 3 years. This is an encore submission of data that have been previously presented [1] and published [2].

METHODS AND RESULTS: Low risk patients were randomized to TAVR with a self-expanding, supra-annular CoreValve, Evolut R, or PRO bioprosthesis (Medtronic, Minneapolis, MN) or SAVR. Clinical outcomes reported as Kaplan-Meier estimates and echocardiographic outcomes were assessed at 3 years. Patient-prosthesis mismatch (PPM) was defined per VARC-3. There were 1414 attempted implants (730 TAVR; 684 SAVR). Patients had a baseline mean age of 74 years and STS score of 2.0% and 1.9% in the TAVR and SAVR groups, respectively. At 3 years, the primary endpoint of all-cause mortality or disabling stroke was 7.4% with TAVR vs 10.4% with SAVR (p=0.051). The differences in Kaplan-Meier rates for the primary endpoint for the TAVR vs SAVR groups were broadly consistent over time: Year 1 = -1.8%; Year 2 = -2.0%; Year 3 = -2.9% (Figure). The composite of all-cause mortality, disabling stroke, or aortic valve rehospitalization was 13.2% with TAVR vs 16.8% with SAVR (p=0.050). The rate of new permanent pacemaker was 23.2% with TAVR vs 9.1% with SAVR (p < 0.001). Clinical (0.3% vs 0.2%, p=0.61) and subclinical (0.4% vs 0.5%, p=0.91) valve thrombosis rates were low in both groups. Mean gradient (9.1 vs 12.1 mmHg, p< 0.001) and effective orifice area (2.2 vs 2.0 cm2, p< 0.001) were significantly better in the TAVR group. TAVR patients had significantly less ≥moderate PPM (10.6% vs 25.1%, p< 0.001). Moderate or greater paravalvular leakage (PVL) occurred in 0.9% of TAVR and 0.2% of SAVR patients (p=0.16).

Conclusion: Low risk patients who underwent TAVR with a self-expanding valve continue to have favorable clinical outcomes through 3 years. TAVR continued to show better valve hemodynamics at 3 years with a high proportion of none/trace PVL and low incidence of valve thrombosis.

[1] Forrest JK, et al. Presented at ACC Scientific Sessions 2023; March 5, 2023, New Orleans, LA, USA
[2] Forrest JK, et al. J Am Coll Cardiol. 2023;81(17):1663-1674.10.1016/j.jacc.2023.02.017