TAVR in Asymptomatic Severe Aortic Stenosis

 Philippe Généreux, M.D., Morristown Medical Center and colleagues conducted a study to evaluate transcatheter aortic-valve replacement (TAVR) for patients with asymptomatic severe aortic stenosis. Current guidelines recommend clinical surveillance every 6–12 months for these patients, yet evidence supporting early TAVR as a strategy is limited. The EARLY TAVR trial, funded by Edwards Lifesciences, examined the efficacy of early intervention compared to routine monitoring.

Methods involved randomizing 901 patients at 75 centers across the U.S. and Canada, assigning them to either early TAVR or clinical surveillance. Participants, predominantly low-risk surgical candidates with a mean age of 75.8 years, were tracked for death, stroke, or unplanned hospitalization due to cardiovascular issues. Statistical analysis showed the trial had sufficient power to assess these outcomes.

Results indicated that early TAVR significantly reduced the primary endpoint events. Specifically, 26.8% of the TAVR group experienced primary events, compared to 45.3% in the surveillance group, reflecting a 50% lower hazard ratio for the TAVR group. Moreover, early TAVR patients had fewer hospitalizations and strokes, and a larger percentage (86.6%) had favorable outcomes based on Kansas City Cardiomyopathy Questionnaire (KCCQ) scores.

In clinical surveillance, about 87% ultimately required aortic-valve replacement, with many displaying advanced symptoms prior to intervention. This progression highlights the unpredictable nature of aortic stenosis and its impact on cardiac function. In this trial, TAVR proved safer and more effective for delaying cardiac deterioration without increasing procedural risks.

While clinical surveillance remains a common strategy, early TAVR offers significant benefits in reducing severe complications. However, limitations include potential differences in real-world care settings, the exclusion of high-risk populations, and racial homogeneity in the study sample. Nevertheless, the study advocates for early TAVR in appropriate patients to prevent deterioration and improve outcomes.

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