Effect of Dapagliflozin on Quality of Life of Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

Abstract

Patients with aortic stenosis who undergo transcatheter aortic valve implantation (TAVI) experience a great improvement in health status. Dapagliflozin has been shown to reduce death and heart failure (HF) in these patients. However, the impact of dapagliflozin on improving health status after TAVI is unknown. In this prespecified analysis of the DapaTAVI (Dapagliflozin After Transcatheter Aortic Valve Implantation) trial, we examined the effects of dapagliflozin on health status by using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The DapaTAVI trial randomized patients undergoing TAVI to receive or not receive dapagliflozin. We assessed the change in KCCQ score from baseline to 3 and 12 months by using an ordinal logistic regression model. Additionally, we analyzed the effect of dapagliflozin on the composite of death or worsening HF by baseline KCCQ score. A total of 964 patients had baseline KCCQ scores (mean 39.5 ± 22.2). Patients in both arms of the study exhibited improvements in KCCQ score, without significant differences between groups in the change in KCCQ score at 3 or 12 months (3-month OR for improvement: 0.96; 95% CI: 0.72-1.26; P = 0.745; 12-month OR: 1.03; 95% CI: 0.83-1.27; P = 0.819). At 12 months, similar proportions of patients in the dapagliflozin and control groups showed clinically meaningful improvements, with 43.4% vs 45.4%, respectively, improving by >50 points. The clinical benefits of dapagliflozin after TAVI appeared to be similar across the full range of baseline KCCQ scores. TAVI was associated with a substantial improvement in KCCQ scores. However, the addition of dapagliflozin following the procedure did not confer an additional benefit in health status compared with standard care. (Dapagliflozin After Transcatheter Aortic Valve Implantation [DapaTAVI]; NCT04696185).