Impact of age on health status after TAVI or SAVR in low risk patients with severe aortic stenosis: results from the PARTNER 3 Trial

Abstract Background Transcatheter aortic valve implantation (TAVI) results in similar 5-year survival and quality of life compared with surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) and low surgical risk. Whether participants’ age at the time of intervention influences the health status benefit of TAVI vs. SAVR is unknown. Purpose To assess the relationship between age and both the short- and long-term health status outcomes of TAVI vs. SAVR among patients enrolled in the PARTNER 3 trial. Methods We used data from the PARTNER 3 randomized trial to compare health status outcomes between TAVI and SAVR, stratified by age (<70, 70-74, 75-79, ≥80 years). Health status was assessed at baseline, 1 month, 6 months, 12 months and annually through 5 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The primary endpoint was the KCCQ overall summary score (KCCQ-OS) over the 5-year follow-up period (range 0-100; higher=better). The key secondary endpoint was an excellent outcome, defined as a KCCQ-OS>75 at 5-year follow-up without a decline of >10 points from baseline. Results Between March 2016 and October 2017, 1000 low-risk patients with severe AS were randomized in a 1:1 fashion to transfemoral TAVR using the balloon-expandable Sapien 3 valve or surgery in the PARTNER 3 trial. Among patients who underwent TAVI or SAVR (and had baseline health status available; TAVI: 494, SAVR: 449), 228 (24%) were <70, 284 (30%) were 70-74, 287 (31%) were 75-79, and 144 (15%) were ≥80 years old. Baseline health status was similar between the TAVI and SAVR groups as well as across age strata. At 30-day follow-up, health status was substantially better with TAVI than SAVR with similar differences across age strata (mean difference 13-18 points; Figure 1). At all other timepoints, there were no significant differences between TAVI and SAVR in any age group. The proportion of TAVI patients with an excellent outcome at 5-year follow-up ranged from 86% in the youngest subgroup to 73% in the oldest subgroup, with no significant differences compared with SAVR. Conclusions Among patients with severe AS at low surgical risk, TAVI using the SAPIEN 3 balloon-expandable valve resulted in substantially better health status in the early post-procedure period compared with SAVR across all age strata. Beyond the early recovery period, intermediate- and longer-term health status outcomes were similar with TAVI and SAVR, with no evidence of heterogeneity by age. Although longer term follow-up is necessary (and ongoing), these 5-year outcomes suggest that over the age range included in the PARTNER 3 trial, age alone should not play a dominant role in determining treatment recommendations for patients with severe AS.Health status by treatment and age group