Key result
Female and male patients show similar 3-year survival and health status after transfemoral TAVR.
Why the study?
Sex-specific disparities in patient-reported outcomes and health status among patients with symptomatic severe aortic stenosis undergoing transfemoral TAVR were not fully investigated.
Does sex affect clinical outcomes and patient-reported health status following transfemoral TAVR in patients with symptomatic severe aortic stenosis?
RCT (n=692)
Randomized (post-hoc sex-stratified analysis of the SCOPE I randomized trial)
Yes
Does sex affect clinical outcomes and patient-reported health status following transfemoral TAVR in patients with symptomatic severe aortic stenosis?
After transfemoral TAVR, male and female patients achieve comparable rates of survival with good health status at 3 years, as higher mortality in men offsets lower patient-reported health status scores in women.
Net 3-year TAVR outcomes similar by sex; leaves open whether sex-specific strategies can further optimize health status or survival.
Background Sex-specific disparities in patient-reported outcomes amongst patients undergoing transcatheter aortic valve replacement (TAVR) are not fully investigated. Objectives 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 732 patients who underwent TAVR, 692 (394 female and 298 male) were included in the analysis of patient-centered outcome. 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 consistently 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 a similar proportion of patients who were alive with good health status at 3 years between groups (42.7% vs. 46.1%). Conclusions In this post-hoc analysis of SCOPE I, male and female patients achieved a similar rate of the patient-centered outcome up to 3 years after TAVR, despite contrasting patterns in patient-reported health status and survival.
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Tomii et al. (2026) conducted an RCT in Symptomatic severe aortic stenosis undergoing transfemoral TAVR (n=692). Female sex (among patients undergoing transfemoral TAVR) vs. Male sex (among patients undergoing transfemoral TAVR) was evaluated on Integrated patient-centered outcome at 3 years, defined as being alive with good health status (KCCQ-OS ≥75 without a decline of >10 points from baseline). Female and male patients undergoing transfemoral TAVR achieved similar rates of being alive with good health status (KCCQ-OS ≥75) at 3 years (42.7% vs. 46.1%).
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