Article Impact Level: HIGH Data Quality: STRONG Summary of New England Journal of Medicine, NEJMoa2307447. https://doi.org/10.1056/NEJMoa2307447 Dr. Michael J. Mack et al.
Points
- This research compared transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement in low-risk patients with severe aortic stenosis.
- The study found no significant difference between TAVR and surgery in terms of the composite end point of death, stroke, or rehospitalization related to the valve, procedure, or heart failure.
- The second primary endpoint, which included death, disabling stroke, non-disabling stroke, and rehospitalization days, also showed no significant difference between the two groups.
- As measured by the mean valve gradient, hemodynamic performance was similar between the TAVR and surgery groups.
- Bioprosthetic-valve failure occurred in a small percentage of patients in both the TAVR and surgery groups.
Summary
This research paper aimed to assess the longer-term outcomes of transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement in low-risk patients with severe, symptomatic aortic stenosis. A total of 1000 patients were randomly assigned to either TAVR or surgery. The primary composite endpoint, which included death, stroke, or rehospitalization related to the valve, procedure, or heart failure, occurred in 22.8% of the TAVR group and 27.2% of the surgery group. However, the between-group difference was not statistically significant (difference, -4.3 percentage points; 95% confidence interval [CI], -9.9 to 1.3; P=0.07).
The second primary endpoint, a hierarchical composite that included death, disabling stroke, non-disabling stroke, and the number of rehospitalization days, also showed no significant difference between the TAVR and surgery groups (win ratio, 1.17; 95% CI, 0.90 to 1.51; P=0.25). The Kaplan-Meier estimates for the components of the first primary endpoint showed similar rates of death, stroke, and rehospitalization between the two groups. The hemodynamic performance of the valve, as assessed by the mean valve gradient, was comparable between the TAVR and surgery groups. Bioprosthetic-valve failure occurred in a small percentage of patients in both groups (3.3% in the TAVR group and 3.8% in the surgery group).
In conclusion, among low-risk patients with severe, symptomatic aortic stenosis, there was no significant difference in the two primary composite outcomes between TAVR and surgery. These findings suggest that both treatment options may be equally effective in this patient population. Further research and longer-term follow-up are needed to fully understand the comparative outcomes of TAVR and surgery in low-risk patients with aortic stenosis.
Link to the article: https://www.nejm.org/doi/10.1056/NEJMoa2307447
References Mack, M. J., Leon, M. B., Thourani, V. H., Pibarot, P., Hahn, R. T., Genereux, P., Kodali, S. K., Kapadia, S. R., Cohen, D. J., Pocock, S. J., Lu, M., White, R., Szerlip, M., Ternacle, J., Malaisrie, S. C., Herrmann, H. C., Szeto, W. Y., Russo, M. J., Babaliaros, V., … Makkar, R. (2023). Transcatheter aortic-valve replacement in low-risk patients at five years. New England Journal of Medicine, NEJMoa2307447. https://doi.org/10.1056/NEJMoa2307447
