Patients with heart failure who took dapagliflozin, a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, after undergoing transcatheter aortic valve replacement (TAVR) were significantly less likely to die or experience worsening heart failure at one year compared with patients who did not take the drug, according to a study presented at the American College of Cardiology's Annual Scientific Session (ACC.25).
SGLT-2 inhibitors have been shown to reduce heart failure hospitalizations but have not previously been tested in those undergoing TAVR, also known as transcatheter aortic valve implantation or TAVI. TAVR/TAVI is a less invasive option than open heart surgery for patients with heart failure and valvular heart disease. This trial, called DapaTAVI, is the first to assess the use of SGLT-2 inhibitors in people undergoing the procedure.
Previous trials have provided evidence for SGLT-2 inhibitors in patients with a variety of other conditions but have excluded patients with valvular heart disease. Based on our study, if you have a patient undergoing TAVI who is at risk of heart failure, it is important to treat them with dapagliflozin or another SGLT-2 inhibitor. These are safe drugs and have a lot of benefit."
Sergio Raposeiras-Roubin, MD, clinical cardiologist at Alvaro Cunqueiro Hospital in Vigo, Spain, professor of medicine at the University of Santiago de Compostela and the study's first author
The DapaTAVI trial enrolled 1,257 patients undergoing TAVR at 39 Spanish hospitals. Participants had an average age of 82 years and half were women. All participants had previously been hospitalized for heart failure and had severe aortic stenosis, a type of valve disease. Participants also had at least one other condition that put them at high risk of poor health outcomes, such as diabetes, poor kidney function or a low left ventricular ejection fraction—a measure of the heart's pumping ability.
Half of the patients were randomly assigned to take dapagliflozin daily starting within two weeks after TAVR and half did not take dapagliflozin. At one year, the rate of the study's primary endpoint, a composite of all-cause death or worsening heart failure (defined as heart failure hospitalization or emergency hospital visit), was 28% lower in patients taking dapagliflozin. This statistically significant improvement was attributed to a 37% reduction in worsening heart failure among those taking dapagliflozin. The two study groups did not see a significant difference in the rate of all-cause death.
Participants taking dapagliflozin reported many of the same side effects from the drug that have been found in previous clinical trials, including low blood pressure. There was no difference between study groups in the rate of urinary tract infections, another side effect associated with SGLT-2 inhibitors. Patients taking dapagliflozin did, however, see a higher rate of genital infection, researchers said. The rate of adverse events was relatively high in both groups due to the advanced age and comorbidities of the study participants.
"We found that these drugs are safe even in our elderly population, who are usually excluded from clinical trials," Raposeiras-Roubin said. "It is important to have evidence in this group of patients; it is good for science and good for physicians to have an independent trial to demonstrate that the [beneficial] effect of SGLT-2 inhibitors is also consistent in subgroups of patients in whom we didn't have evidence until now."
The results were consistent across subgroups in terms of age, sex, kidney function and diabetes status. The researchers plan to further study whether there were any differences by left ventricle ejection fraction. Additional sub-studies are underway to assess quality of life outcomes.
Researchers said that the trial was limited to Spain and included little racial diversity but suggested that the results should be generalizable to other countries. The study was also open label for patients and physicians, but researchers said this was unlikely to influence the study's primary endpoint since clinical outcomes were externally adjudicated by a clinical panel blinded to treatment.
The study was funded by the Spanish Government, the Castilla-León Government, the Spanish Society of Cardiology, and the Galician Society of Cardiology.
This study was simultaneously published online in the New England Journal of Medicine at the time of presentation.
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