Patients with heart failure benefit from dapagliflozin after TAVR procedures

Patients with heart failure benefit from dapagliflozin after TAVR procedures

Patients with heart failure who took dapagliflozin, a sodium-glucose CO transporter-2 inhibitor (SGLT-2), were significantly less likely to experience worsening heart failure in one year after transcatheter aortic valve replacement (TAVR) in a study presented in American Cardiology.

SGLT-2 inhibitors have been shown to reduce heart failure hospitalizations, but have not yet 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 study, called Dapatavi, is the first to evaluate the use of SGLT-2 inhibitors in people undergoing the procedure.

Previous studies have provided evidence for SGLT-2 inhibitors in patients with a variety of other diseases but have excluded patients with valvular heart disease. Based on our study, if you have a patient at risk of TAVI, it is important to treat them with dapagliflozin or another SGLT-2 inhibitor. These are safe drugs and have a lot of benefits. “

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 study included 1,257 patients who underwent TAVR in 39 Spanish hospitals. The 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 for poor health outcomes, such as diabetes, poor kidney function or low left ventricular ejection fraction - a measure of the heart's ability to pump.

Half of the patients were randomly assigned to take daily dapagliflozin within two weeks of TAVR and half did not take dapagliflozin. In one year, the rate of the study's primary endpoint, an composite of death or worsening of heart failure (defined as hospital trials or hospital visits with heart failure), was 28% lower in patients taking dapagliflozin. This statistically significant improvement was attributed to a 37% reduction in heart failure among those who took dapagliflozin. The two study groups saw no significant difference in the rate of all-cause death.

Participants who took dapagliflozin reported many of the same side effects from the drug 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. However, patients who took dapagliflozin saw higher rates of genital infections, 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 typically 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 study to demonstrate that the [beneficial] effect of SGLT-2 inhibitors is consistent even in subgroups of patients where we previously had no evidence."

Results were consistent across subgroups of age, gender, renal function, and diabetes status. The researchers plan to further investigate whether there were differences by left vernation ejection fraction. Additional sub-studies are underway to evaluate quality of life outcomes.

The researchers said the trial was limited to Spain and included low racial diversity, but suggested the results should be generalizable to other countries. The study was also open to patients and doctors, but researchers said this was unlikely to affect the study's primary endpoint because clinical outcomes were externally assessed 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 theNew England Journal of MedicineAt the time of presentation.

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