Article Impact Level: HIGH Data Quality: STRONG Summary of New England Journal of Medicine, 390(17), 1572–1583. https://doi.org/10.1056/NEJMoa2400685 Dr. Stefan Blankenberg et al.
Points
- A study compared TAVI and SAVR in low or intermediate-surgical risk patients with severe aortic stenosis
- 1414 patients were randomized to TAVI or SAVR groups at 38 sites in Germany
- TAVI was non-inferior to SAVR in terms of the primary outcome of death from any cause or stroke at one year
- The incidence of death from any cause and stroke was lower in the TAVI group compared to the SAVR group
- Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively
Summary
In a randomized noninferiority trial conducted at 38 sites in Germany, researchers sought to address the lack of data on the appropriate treatment strategy for low-risk patients with severe, symptomatic aortic stenosis eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR). A total of 1414 patients were assigned to undergo either TAVI or SAVR, with percutaneous- and surgical-valve prostheses selected based on operator discretion. The primary outcome, a composite of death from any cause or fatal or nonfatal stroke at one year, was assessed.
The study revealed that among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was non-inferior to SAVR with respect to the primary outcome at one year. The Kaplan-Meier estimate of the primary outcome at one year was 5.4% in the TAVI group and 10.0% in the SAVR group, with a hazard ratio for death or stroke of 0.53. Additionally, the incidence of death from any cause and stroke was lower in the TAVI group compared to the SAVR group. Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively.
In conclusion, the study demonstrated that TAVI was non-inferior to SAVR in terms of the primary outcome of death from any cause or stroke at one year among patients with severe aortic stenosis at low or intermediate surgical risk. These findings provide valuable insights into the treatment strategy for this patient population, highlighting the potential of TAVI as a viable alternative to SAVR.
Link to the article: https://www.nejm.org/doi/10.1056/NEJMoa2400685
References Blankenberg, S., Seiffert, M., Vonthein, R., Baumgartner, H., Bleiziffer, S., Borger, M. A., Choi, Y.-H., Clemmensen, P., Cremer, J., Czerny, M., Diercks, N., Eitel, I., Ensminger, S., Frank, D., Frey, N., Hagendorff, A., Hagl, C., Hamm, C., Kappert, U., … Falk, V. (2024). Transcatheter or Surgical Treatment of Aortic-Valve Stenosis. New England Journal of Medicine, 390(17), 1572–1583. https://doi.org/10.1056/NEJMoa2400685
