Daijiro Tomii, Jonas Lanz, Dik Heg, Ottavia Cozzi, Holger Thiele, Won-Keun Kim, Michael Joner, Lenard Conradi, Stefan Toggweiler, Bernard Prendergast, Stephan Windecker, Thomas Pilgrim, SCOPE I Investigators
In this post hoc analysis of SCOPE I, there was no statistically significant difference in the likelihood of achieving the patient-centered outcome between male and female patients up to 3 years after TAVR, despite contrasting patterns in patient-reported health status and survival. (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis [SCOPE I]; NCT03011346).
BACKGROUND: Sex-specific disparities in patient-reported outcomes among patients undergoing transcatheter aortic valve replacement (TAVR) are not fully investigated.
OBJECTIVES: The objective of the study was to evaluate sex-based differences in clinical outcomes and health status following transfemoral TAVR in patients with symptomatic severe aortic stenosis.
METHODS: Patients in the investigator-initiated, multicenter SCOPE I randomized trial were stratified by sex. Outcomes of interest included vital status and patient-reported disease-specific health status, with an integrated patient-centered outcome defined as being alive with good health status (Kansas City Cardiomyopathy Questionnaire overall summary score [KCCQ-OS] ≥75 without a decline of >10 points from baseline).
RESULTS: Of the 732 patients who underwent TAVR, 692 (394 females and 298 males) were included. At baseline, female patients had a higher surgical risk and higher prevalence of advanced heart failure symptoms and frailty, whereas male patients had a greater comorbidity burden. Female patients had lower baseline KCCQ-OS, which persisted after TAVR, leading to a lower likelihood of achieving KCCQ-OS ≥75 at 1 year (64.4% vs 74.2%). In contrast, male patients had higher all-cause mortality throughout 3 years of follow-up (26.3% vs 19.5%). These contrasting patterns in patient-reported health status and survival resulted in no statistically significant difference in the proportion of patients who achieved the patient-centered outcome at 3 years (42.7% vs 46.1%).
CONCLUSIONS: In this post hoc analysis of SCOPE I, there was no statistically significant difference in the likelihood of achieving the patient-centered outcome between male and female patients up to 3 years after TAVR, despite contrasting patterns in patient-reported health status and survival. (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis [SCOPE I]; NCT03011346).