Valvular & structural heart diseaseRandomised controlled trial
Sex-Specific Differences in Patient-Centered Outcomes After Transcatheter Aortic Valve Replacement
- randomized trial
- investigator-initiated
- multicenter
- post hoc analysis
- stratified by sex
Authors' conclusion
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).
Study context
- Population
- Patients with symptomatic severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the SCOPE I randomized trialincluded, of the 732 patients who underwent TAVR · females 394 · males 298
- Participants
- 692 patients
- Comparison
- sex-based differences in clinical outcomes and health status following transfemoral TAVR
- female patientsn = 394
- male patientsn = 298
Primary result
As reported in the abstract
KCCQ-OS ≥75 · 1 year
Further findings
All-cause mortality · 3 years
Patient-centered outcome (alive with KCCQ-OS ≥75 without a decline of >10 points from baseline) · 3 years
- no statistically significant difference in the proportion of patients who achieved the patient-centered outcome (42.7% vs 46.1%)
Baseline characteristics
- 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
Original publication
Sex-Specific Differences in Patient-Centered Outcomes After Transcatheter Aortic Valve Replacement. JACC Adv. Published 13 August 2026. doi:10.1016/j.jacadv.2026.103175
Summarised from the published abstract; every number is checked against it