Key result
Early TAVR cuts major events ~50% vs clinical surveillance in asymptomatic severe AS.
Why the study?
Does early TAVR reduce the composite of death, stroke, or unplanned cardiovascular hospitalization in patients with asymptomatic severe aortic stenosis compared to routine clinical surveillance?
RCT (n=901)
1:1 ratio
Yes
Does early TAVR reduce the composite of death, stroke, or unplanned cardiovascular hospitalization in patients with asymptomatic severe aortic stenosis compared to routine clinical surveillance?
Hazard Ratio: 0.5 (95% CI 0.4–0.63)
Absolute Event Rate: 26.8% vs 45.3%
p-value: p=<0.001
Early TAVR significantly reduces the composite of death, stroke, or unplanned cardiovascular hospitalization compared to routine clinical surveillance in patients with asymptomatic severe aortic stenosis.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“What we saw is 26% of the patients convert to symptoms within 6 months, 50% convert within a year, and more than 70% needed aortic valve replacement by 2 years. About 40% of the patients convert with symptoms that are very advanced or acute, meaning pulmonary edema, New York Heart Association class III or IV heart failure, syncope, [or having] survived cardiac arrest. So, there's not a lot of reassurance in waiting.”
“There are no differences in mortality at 4 years, which is an important point. There also are no differences in stroke. The primary endpoint is positive, but it is [driven] mainly by patients who underwent the AVR later on.”
“One thing I noticed was that some patients randomized to the clinical surveillance arm immediately started developing mild symptoms. I'm not saying that this was intentional, but they did know they would likely be treated with TAVR—the procedure they wanted from the jump—as soon as those symptoms started to develop. And once the patient reported symptoms in EARLY TAVR, that was basically it; they were going to get a TAVR valve. It was not up to a screening committee or an objective test, and there was no waiting to see what happened next. As soon as they were symptomatic, we p”
Warrants early TAVR consideration in asymptomatic severe AS; extends RCT evidence beyond symptomatic-only paradigm.
BACKGROUND: For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking. METHODS: At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was performed in the intention-to-treat population. RESULTS: A total of 901 patients underwent randomization; 455 patients were assigned to TAVR and 446 to clinical surveillance. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8% (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after surgery), and 83.6% of patients were at low surgical risk. A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and in 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the patients assigned to clinical surveillance, stroke occurred in 4.2% and 6.7%, respectively, and unplanned hospitalization for cardiovascular causes occurred in 20.9% and 41.7%. During a median follow-up of 3.8 years, 87.0% of patients in the clinical surveillance group underwent aortic-valve replacement. There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who underwent aortic-valve replacement. CONCLUSIONS: Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104.).
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Généreux et al. (2024) conducted an RCT in Asymptomatic severe aortic stenosis (n=901). Early TAVR vs. Clinical surveillance was evaluated on Composite of death, stroke, or unplanned hospitalization for cardiovascular causes (HR 0.50, 95% CI 0.40 to 0.63, p=<0.001). Early TAVR was superior to clinical surveillance in reducing death, stroke, or unplanned cardiovascular hospitalization (HR 0.50; 95% CI 0.40-0.63; P<0.001).
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