Early TAVR bests surveillance in patients with asymptomatic severe aortic stenosis
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Key takeaways:
- TAVR was superior to clinical surveillance in patients with asymptomatic severe aortic stenosis.
- Almost all patients in the clinical surveillance group eventually needed TAVR.
WASHINGTON — Among patients with asymptomatic severe aortic stenosis, those who had transcatheter aortic valve replacement had better CV outcomes compared with those who had routine clinical surveillance, according to results of the EARLY TAVR trial.
“In patients with asymptomatic severe aortic stenosis, a strategy of early TAVR compared with clinical surveillance resulted in a significant reduction in the primary endpoint of death, stroke or unplanned CV hospitalization, and multiple endpoint variations demonstrated consistent results,” Philippe Généreux, MD, co-director of the Structural Heart Program at Morristown Medical Center, Atlantic Health System, New Jersey, said during a press conference at TCT 2024.
For the EARLY TAVR trial, simultaneously published in The New England Journal of Medicine, the researchers randomly assigned 901 patients with asymptomatic severe aortic stenosis (mean age, 75.8 years; 31% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 1.8%; 83.6% at low surgical risk) eligible for clinical surveillance according to current guidelines to receive TAVR with a balloon-expandable valve (Sapien 3 or Sapien 3 Ultra, Edwards Lifesciences) or clinical surveillance. Patients from the TAVR group underwent their procedure an average of 14 days after randomization, Généreux said during the press conference.
At a median follow-up of 3.8 years, the primary endpoint of all-cause death, stroke or unplanned hospitalization for CV causes occurred in 26.8% of the TAVR group and 45.3% of the surveillance group (HR = 0.5; 95% CI, 0.4-0.63; P < .001), Généreux said during the press conference. The number needed to treat to prevent one event at 2 years was six, he said.
The results were driven by unplanned hospitalization for CV causes, which occurred in 20.9% of the TAVR group and 41.7% of the surveillance group (HR = 0.43; 95% CI, 0.33-0.55), the researchers found. Death from any cause occurred in 8.4% of the TAVR group and 9.2% of the surveillance group (HR = 0.93; 95% CI, 0.6-1.44), whereas stroke occurred in 4.2% of the TAVR group and 6.7% of the surveillance group (HR = 0.62; 95% CI, 0.35-1.1).
During the study period, 87% of the surveillance group eventually underwent TAVR, according to the researchers. By 5 years, that figure reached 95.2%, Généreux said during the press conference.
There were no differences between the groups in procedure-related adverse events.
More patients from the TAVR group than from the surveillance group met the secondary endpoint of favorable outcome at 2 years, defined as being alive and having a Kansas City Cardiomyopathy Questionnaire score of 75 or more that had not decreased more than 10 points from baseline (86.6% vs. 68%; P < .001), according to the researchers.
“Given the benefits observed and the lack of harm, early TAVR may be preferred to clinical surveillance in patients with asymptomatic severe [aortic stenosis], especially when combined with the challenges of timely symptom recognition and prompt treatment in real-world settings,” Généreux said during the press conference.
Reference:
Perspective
Back to TopFor a long time now, we have diagnosed severe aortic stenosis, and we have our patients come back every 6 to 12 months and monitor them. This trial now allows us to say, based on the circumstances of the individual patient, we can do a procedure, TAVR, that potentially can improve their outcomes. I think this has implications for equity of care as well. Once a patient is diagnosed with severe aortic stenosis, we know it is progressive. We know they will get to a symptomatic stage. Until now, we have had them wait until they get symptoms, and come back for monitoring in the meantime. The burdens of periodic echocardiograms and clinical follow-ups are disproportionate for certain patient populations. I am excited that now, depending on patient circumstances, we can recommend earlier treatment, even if they haven’t reached the symptomatic stage. In certain patients, it will make a big difference.
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Généreux P, et al. Late-breaking clinical trials: Session I, in collaboration with The New England Journal of Medicine. Presented at: TCT Scientific Symposium; Oct. 27-30, 2024; Washington, D.C. (hybrid meeting).
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