Evolut Trial: TAVR Outperforms SAVR in Low-Risk Patients With Aortic Stenosis

Patients with severe aortic stenosis who have low surgical risk have better valve performance and clinical outcomes using transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR), according to 4-year data from the Evolut Low Risk trial. The findings were reported at TCT 2023.

In the United States, the number of TAVR procedures is growing, and there has been a notable increase in the number of younger adults with aortic stenosis being treated. The Evolut trial is the first study to evaluate the use of TAVR in this low-risk patient population.

In this analysis, 1414 patients were randomized 1:1 to undergo TAVR (n=730) or SAVR (n=684). The researchers noted that at 4-year follow-up, 94.7% of TAVR patients and 89.2% of SAVR patients were available for evaluation.

The findings showed that the primary end point (all-cause mortality or disabling stroke at 4 years) was 10.7% in the TAVR group versus 14.1% for SAVR (hazard ratio, 0.74; 95% CI, 0.54-1.00; P=.05). The researchers noted that the difference between the 2 groups for the primary end point continued to increase over time.

Moreover, the study found that the composite of all-cause mortality, disabling stroke, or aortic valve rehospitalization was 18.0% with TAVR versus 22.4% with SAVR (P=.04). TAVR patients had significantly better cardiac hemodynamics, investigators noted.

“This longer-term data from the Evolut trial can help guide treatment decisions for low-risk patients with severe aortic stenosis,” said Michael J. Reardon, MD, the Allison Family Distinguished Chair in Cardiovascular Research and professor of cardiovascular surgery at Houston Methodist, via a press release. “Not only did TAVR provide better initial outcomes compared [with] SAVR, but the benefit also continued to increase over time. Patients will be followed for 10 years to determine whether there is additional divergence of the clinical outcomes.”