News: Upfront TAVR more protective against death, heart failure, study suggests
Upfront transcatheter aortic valve replacement (TAVR) was more protective against death and heart failure events compared with clinical surveillance among patients with moderate aortic stenosis (AS) with at least one at-risk feature, a study published in the New England Journal of Medicine showed.
At two years, a composite endpoint of death from any cause or a heart failure event occurred in 16.7% of patients in the upfront TAVR group versus 23.9% of those in the clinical surveillance group. In addition, TAVR with the balloon-expandable SAPIEN 3 platform had a safety event rate of 5.9% at 30 days, which was well under the prespecified 13.7% performance goal. The bulk of events were hospitalizations for device- or procedure-related complications (5.6%).
Among the clinical surveillance patients who started out with moderate AS, 57.4% eventually underwent a delayed aortic valve replacement by 24 months. Of these patients, over 80% had progressed to severe AS.
Out of 1,294 patients screened, 744 were randomized 1:1 to transfemoral TAVR or once-yearly clinical surveillance from October 2021 to January 2024. The Society of Thoracic Surgery risk score was about 3.0%, and fewer than half of patients were deemed low risk per the heart team. New York Heart Association class III/IV symptoms were observed in about 35% at baseline. The Kansas City Cardiomyopathy Questionnaire (KCCQ) score was about 64 on average.
The top at-risk features that qualified people for the study were valve-related symptoms (96.4%) and diastolic dysfunction (43.8%).
Researchers reported that 91% of enrolled patients had moderate AS in terms of both moderate aortic valve area (AVA) criteria and peak velocity/mean gradients. The mean AVA was 1.2 cm2, the mean gradient was just over 25 mm Hg, and the peak velocity was 3.3 m/s. About one in four people had an elevated aortic valve calcium score.
The effectiveness endpoint was a composite of death (8.4% versus 7.3%) and heart failure events (10.8% versus 19.0%). Of note, a heart failure event had to meet all three criteria: new or worsening heart failure symptoms, two or more objective indications of new or worsening heart failure (physical, laboratory, imaging, and/or invasive findings), and escalation of heart failure treatment. Altogether, the number needed to treat for benefit at two years was 14 in the trial.
Separately, as a standalone endpoint, heart failure hospitalizations were fewer in the TAVR arm (7.4% versus 14.9%). However, the composite of death, stroke, or heart failure hospitalization did not statistically give TAVR an edge (17.7% versus 23.3%).
As for health status improvement, the mean KCCQ score was 79.6 points in the TAVR arm at 30 days. The proportion of patients alive with an improvement of 10+ points in KCCQ score at one and two years favored TAVR (39.0% versus 23.2%).
“Moderate AS is not benign, and these patients would benefit from earlier referral to a valve clinic for comprehensive evaluation to establish the optimal management strategy,” researchers concluded. “Rather than waiting for progression to severe AS, PROGRESS supports TAVR for patients with moderate AS and at-risk features.”
Editor’s note: To read the full study, click here. To read additional coverage from MedPage Today, click here. To listen to the ACDIS Podcast episode covering TAVR reviews, click here.