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March 30, 2025
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Key takeaways:
Dapagliflozin was safe and effective at 1 year among older patients with aortic stenosis and HF who underwent TAVR.
Genital infections and hypotension were more common in the dapagliflozin group.
CHICAGO — The first trial to evaluate use of an SGLT2 inhibitor in people undergoing transcatheter aortic valve replacement showed benefit with dapagliflozin compared with standard care alone, including in older patients.
Sergio Raposeiras-Roubin
“Among elderly patients with aortic stenosis undergoing TAVI and at high risk for heart failure, dapagliflozin was safe and reduced the incidence of all-cause death or worsening heart failure,” Sergio Raposeiras-Roubin, MD, PhD, clinical cardiologist at Álvaro Cunqueiro Hospital in Vigo, Spain, and professor of medicine at University of Santiago de Compostela, said while presenting the DapaTAVI trial results at the American College of Cardiology Scientific Session.
The trial enrolled 1,257 patients (49.4% women) with severe aortic stenosis who were undergoing TAVR at 39 hospitals across Spain. All patients had a prior hospitalization for HF and at least one of the following: diabetes (44%), left ventricular systolic dysfunction (17%) or poor kidney function (89%).
This was an older population: The mean age was 82 years; 72% of patients were older than 80 years, and 7% older than 90 years, Raposeiras-Roubin said.
Half of the patients were randomly assigned to once-daily dapagliflozin 10 mg (Farxiga, AstraZeneca), started within 2 weeks following TAVR, and the other half received standard care only.
At 1 year, the primary endpoint of all-cause death or worsening HF occurred in 15% of the dapagliflozin group compared with 20.1% of the standard care group — a 28% relative reduction in risk (HR = 0.72; 95% CI, 0.55-0.95; P = .02), according to the results.
Improvement in the primary endpoint was attributed to a 37% reduction in worsening HF in the dapagliflozin group (9.4% vs. 14.4%; subhazard ratio = 0.63; 95% CI, 0.45-0.88). Worsening HF was defined as HF hospitalization or an urgent visit.
The researchers reported no difference in all-cause death, which occurred in 7.8% of the dapagliflozin group compared with 8.9% of the standard care group (HR = 0.87; 95% CI, 0.59-1.28).
The effect of dapagliflozin on the primary endpoint also appeared consistent across prespecified subgroups, regardless of diabetes, LV systolic dysfunction or kidney function, Raposeiras-Roubin said during the presentation.
Genital infections (1.8% vs. 0.5%) and hypotension (6.6% vs. 3.6%) were more common in the dapagliflozin group. There was no difference in urinary tract infections, which is an adverse event that has been associated with SGLT2 inhibitors.
The researchers noted several limitations of the DapaTAVI trial, including its pragmatic and open-label design; the lower-than-expected observed primary endpoint event rate, which required an increase in sample size; its conduct in only Spain; and lack of collection of data on race/ethnicity.
The data were simultaneously published in The New England Journal of Medicine.
TAVR has changed the current management of aortic stenosis, but many patients still have high rates of HF, especially in the first year after valve replacement, Raposeiras-Roubin said during a press conference. SGLT2 inhibitors have shown benefits across the spectrum of HF, but patients with HF secondary to valvular disease or undergoing valve interventions have been excluded from randomized clinical trials with SGLT2 inhibitors, he said. Also, patients undergoing TAVR are generally older, and patients older than 80 years are also underrepresented in randomized clinical trials with SGLT2 inhibitors, according to Raposeiras-Roubin.
“Our current findings extend the evidence from previous trials of SGLT2 inhibitors. By including older patients undergoing aortic valve replacement, we found clinically relevant benefits of dapagliflozin in this patient population after TAVI,” the researchers wrote in NEJM.
Deepak L. Bhatt
During a discussion following the late-breaking clinical trial presentation, Deepak L. Bhatt, MD, MPH, MBA, said DapaTAVI is a “practice-changing trial.”
“In my TAVR patients, [dapagliflozin] is not part of the checklist. I think these results are immediately practice changing in patients who don’t have contraindications or otherwise meet the eligibility criteria of the DapaTAVI trial,” said Bhatt, who is director of the Mount Sinai Fuster Heart Hospital, the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai and a Healio | Cardiology Today Editorial Board Member.
Reference:
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Sources/DisclosuresCollapse
Source:
Raposeiras-Roubin S, et al. Joint American College of Cardiology/Journal of the American Medical Association late-breaking clinical trials III. Presented at: American College of Cardiology Scientific Session; March 29-31, 2025; Chicago (hybrid meeting).
Disclosures:
Raposeiras-Roubin reports no relevant financial disclosures.
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