Outcomes following self-expanding transcatheter or surgical aortic valve implantation in patients at low operative risk stratified by need for revascularization

Abstract

Abstract Background Self-expanding transcatheter aortic valve implantation (TAVI) was non-inferior to surgical aortic valve replacement (SAVR) in a randomized clinical trial of patients with severe aortic stenosis at low operative risk. Randomization was stratified by the need for revascularization, but it remains unclear how this has impacted the results of TAVI and SAVR. Purpose To compare TAVI and SAVR outcomes in a prespecified analysis according to the need for revascularization. Methods A total of 1403 patients underwent attempted TAVI (n=725) or SAVR (n=678) at 87 centres worldwide. Patients were deemed at low risk of early mortality (<3%) confirmed by a national screening committee. Patients were stratified by site and need for revascularization based on heart team assessment. The trial used a Bayesian study design for the 2-year primary analysis and an interim analysis was performed when 850 patients had reached 1-year follow-up. Results There were 85/725 (11.7%) TAVI patients and 79/678 (11.7%) SAVR patients identified as needing revascularization. Previous CABG had occurred in 3 (1.8%) patients and previous PCI had been performed in 31 (18.9%) patients. The baseline characteristics for the TAVI and SAVR cohorts are shown in the table. In the TAVI revascularization group, 44 of 85 (51.8%) received PCI concomitant or staged with TAVI and 6 of 639 (0.9%) received PCI in the no revascularization group. In the SAVR revascularization group, 65 of 79 (82.3%) underwent concomitant CABG and 27 of the 599 (4.5%) patients in the no revascularization group had concomitant CABG. Kaplan-Meier estimates of 1-year all-cause mortality or disabling stroke at the time of the interim analysis are provided for TAVI and SAVR patients by need for revascularization (Table). Conclusions The proportion of low-risk patients needing revascularization was small in this low risk population. The complete 1-year follow-up for the entire 1403 patient cohort will be available for presentation in August. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic, plc