TCT CONNECT-125 TAVR With a Supra-Annular, Self-Expandable Valve in Intermediate Risk Patients: Follow-Up From the SURTAVI Randomized Trial and Continued Access Registry

Background: The SURTAVI trial is a prospective, multicenter, randomized clinical trial (RCT) that confirmed the noninferiority of transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement for the primary endpoint of all-cause mortality or disabling stroke at 2 years. Following completion of enrollment in the randomized trial, eligible patients were enrolled in the SURTAVI continued access study (CAS) in order to obtain additional data on the use of the second generation Evolut-R bioprosthesis. Our aim was to compare clinical outcomes and hemodynamics of patients in the CAS versus TAVR arm of the RCT (TAVR-RCT). Methods: Eligible patients were required to have a predicted risk for 30-day surgical mortality of ≥3% and <15%. The SURTAVI RCT predominantly used the first-generation CoreValve (n = 724) and less frequently next-generation Evolut R device (n = 139) whereas the SURTAVI CAS treated 255 of 275 patients with Evolut R and only 20 patients with a 31-mm CoreValve device. Results: Baseline characteristics of the CAS and RCT patients included mean age (79.0 ± 6.1 vs. 79.9 ± 6.2 years), sex (male: 46.2% vs. 57.6%), and mean Society of Thoracic Surgeons score (4.1 ± 1.5 vs. 4.4 ± 1.5). When compared with the RCT results without any adjustments, the 30-d and 2-y rates of all-cause mortality, disabling stroke, aortic valve hospitalization, and permanent pacemaker implantation were numerically lower in the CAS population (Table). Hemodynamic performance was comparable between RCT and CAS patients at 2 years. [Formula presented] Conclusion: TAVR with the supra-annular, self-expandable Evolut R prosthesis compared with first-generation CoreValve in intermediate-risk patients resulted in numerically improved 30-days and 2-years clinical outcomes, lower rates of permanent pacemaker implantation and excellent hemodynamic performance. Categories: STRUCTURAL: Valvular Disease: Aortic