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Published on: June 3, 2018
Dapagliflozin in Patients Undergoing Transcatheter Aortic-Valve Implantation
Sergio Raposeiras-Roubin1,2,3, Ignacio J Amat-Santos4,5, Xavier Rossello1,4,6,7
1Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid.
Insights
Dapagliflozin significantly reduced heart failure events in high-risk patients undergoing transcatheter aortic-valve implantation (TAVI). This SGLT2 inhibitor offers a new treatment option for these vulnerable individuals.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Sodium-glucose cotransporter 2 (SGLT2) inhibitors are known to reduce heart failure admissions in high-risk populations.
- Patients with valvular heart disease, particularly those undergoing transcatheter aortic-valve implantation (TAVI), have been largely excluded from previous SGLT2 inhibitor trials.
Purpose of the Study:
- To evaluate the efficacy of dapagliflozin in patients with aortic stenosis undergoing TAVI.
- To assess the impact of dapagliflozin on the composite outcome of death or worsening heart failure in this specific patient group.
Main Methods:
- A randomized, controlled trial was conducted in Spain involving 1222 patients with aortic stenosis post-TAVI.
- Patients had a history of heart failure plus renal insufficiency, diabetes, or left ventricular systolic dysfunction.
- The primary outcome was a composite of all-cause death or heart failure worsening at 1-year follow-up, comparing dapagliflozin (10 mg daily) to standard care.
Main Results:
- The primary outcome occurred in 15.0% of the dapagliflozin group versus 20.1% in the standard-care group (hazard ratio, 0.72; P=0.02).
- Worsening heart failure was significantly reduced in the dapagliflozin group (9.4% vs. 14.4%).
- Genital infections and hypotension were more frequent with dapagliflozin.
Conclusions:
- Dapagliflozin significantly lowered the incidence of death or heart failure worsening in high-risk older adults with aortic stenosis undergoing TAVI.
- The findings suggest dapagliflozin is a beneficial addition to standard care for this patient population.
Background:
Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of heart-failure admission among high-risk patients. However, most patients with valvular heart disease, including those undergoing transcatheter aortic-valve implantation (TAVI), have been excluded from randomized trials.
Methods:
We conducted this randomized, controlled trial in Spain to evaluate the efficacy of dapagliflozin (at a dose of 10 mg once daily) as compared with standard care alone in patients with aortic stenosis who were undergoing TAVI. All the patients had a history of heart failure plus at least one of the following: renal insufficiency, diabetes, or left ventricular systolic dysfunction. The primary outcome was a composite of death from any cause or worsening of heart failure, defined as hospitalization or an urgent visit, at 1 year of follow-up.
Results:
A total of 620 patients were randomly assigned to receive dapagliflozin and 637 to receive standard care alone after TAVI; after exclusions, a total of 1222 patients were included in the primary analysis. A primary-outcome event occurred in 91 patients (15.0%) in the dapagliflozin group and in 124 patients (20.1%) in the standard-care group (hazard ratio, 0.72; 95% confidence interval [CI], 0.55 to 0.95; P = 0.02). Death from any cause occurred in 47 patients (7.8%) in the dapagliflozin group and in 55 (8.9%) in the standard-care group (hazard ratio, 0.87; 95% CI, 0.59 to 1.28). Worsening of heart failure occurred in 9.4% and 14.4% of the patients, respectively (subhazard ratio, 0.63; 95% CI, 0.45 to 0.88). Genital infection and hypotension were significantly more common in the dapagliflozin group.
Conclusions:
Among older adults with aortic stenosis undergoing TAVI who were at high risk for heart-failure events, dapagliflozin resulted in a significantly lower incidence of death from any cause or worsening of heart failure than standard care alone. (Funded by Instituto de Salud Carlos III and others; ClinicalTrials.gov number, NCT04696185.).
