Elderly TAVI patients with aortic stenosis also benefit from dapagliflozin
ACC.25 – The DapaTAVI trial demonstrated dapagliflozin safely reduced the risk of all-cause mortality or HF worsening compared with standard care only in elderly with severe aortic stenosis undergoing TAVI who were at high risk of HF.
This summary is based on the presentation of Sergio Raposeiras-Roubin, MD, PhD (Vigo, Spain) at the ACC.25 Scientific Session - Dapagliflozin In Patients Undergoing Transcatheter Aortic Valve Implantation.
Introduction and methods
In RCTs with SGLT2 inhibitors, patients with HF secondary to valvular heart disease, those undergoing TAVI, and very elderly people are underrepresented. Hence, there is a need for evidence on the efficacy and safety of SGLT2 inhibitors in patients aged >80 years who have aortic stenosis and are undergoing TAVI.
The DapaTAVI (Dapagliflozin After Transcatheter Aortic Valve Implantation) trial was a multicenter, independent, pragmatic, open-label, blinded-endpoint, phase 4 RCT conducted in Spain in which 1257 patients with severe aortic stenosis undergoing TAVI were randomized at hospital discharge to dapagliflozin 10 mg once daily in addition to standard care or standard care only. Inclusion criteria were prior HF hospitalization and either LVEF ≤40%, presence of DM, or eGFR 25–75 mL/min/1.73 m². Mean ± SD age of the intention-to-treat population (n=1222) was 82.4 ± 5.5 years (median: 83 years; IQR: 79–86), and 7.4% of the patients were ≥90 years old.
The primary endpoint was a composite outcome of centrally adjudicated all-cause mortality or worsening HF (i.e., HF hospitalization and urgent HF visit requiring intravenous diuretics). Key secondary endpoints included the individual components of the primary endpoint; CV death; a composite outcome of HF hospitalization or CV death; and the total number of HF rehospitalizations. Safety endpoints included genitourinary infections, major hypoglycemia, and hypotension.
Main results
- In the primary intention-to-treat analysis, the primary endpoint occurred in 91 of the 605 patients (15.0%) treated with dapagliflozin and 124 of the 617 patients (20.1%) receiving standard care only (HR: 0.72; 95%CI: 0.55–0.95; P=0.018).
- The rate of all-cause mortality was similar in the dapagliflozin and standard-care groups (7.8% vs. 9.1%; HR: 0.87; 95%CI: 0.59–1.28), whereas HF worsening was less frequently seen in the dapagliflozin group than the standard-care group (9.4% vs. 14.4%; subdistribution HR: 0.63; 95%CI: 0.45–0.88).
- The frequency of genital infections was 1.8 events per 100 person-years in the dapagliflozin group and 0.5 events per 100 person-years in the standard-care group (P=0.03), whereas the rate of hypotension was 6.6 and 3.6 events per 100 person-years, respectively (P=0.01).
Conclusion
The DapaTAVI trial demonstrated that dapagliflozin reduced the risk of all-cause mortality or HF worsening compared with standard care only in elderly patients with severe aortic stenosis undergoing TAVI who were at high risk of HF. There were no significant safety concerns.
- Our reporting is based on the information provided at the ACC.25 Scientific Session -