BACKGROUND: TAVR is preferred over surgical aortic valve replacement in frail patients with aortic stenosis. The assessment of the treatment benefit of TAVR in this population is however equivocal. OBJECTIVES: The purpose of this study was to investigate the impact of frailty on clinical and patient-reported outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS: Patients in the SCOPE I (Safety and Efficacy of the ACURATE Neo/TF Compared to the SAPIEN 3 Bioprosthesis) trial were stratified according to frailty, defined as a multicomponent index that included loss of independence criteria based on activities of daily living, lean body mass, serum albumin, and cognitive impairment or dementia. The outcomes of interest included an endpoint integrating vital and patient-reported disease-specific health status, as well as clinical efficacy according to the Valve Academic Research Consortium (VARC)-3 definition. RESULTS: Among 739 randomized patients, 122 patients (16.5%) met the definition of frailty. Mean age, comorbidities, and surgical risk were comparable between groups. Patients with and without frailty had similar improvement in patient-reported health status measures after TAVR, while patients with frailty had an increased risk of VARC-3 unfavorable outcome (risk ratio: 1.38, 95% CI: towards reduced VARC-3 clinical efficacy (risk ratio: 0.82
95% CI: 0.65-1.03) at 3 years after TAVR. CONCLUSIONS: More than 1 in 6 patients with severe aortic stenosis undergoing TAVR were considered frail in the SCOPE I trial. Patients with frailty had a similar improvement in patient-reported health status measures after TAVR, but a higher risk of unfavorable outcomes throughout 3 years of follow-up.