A large-scale meta-analysis suggests that for patients with severe symptomatic aortic stenosis (AS) at a low- to intermediate-surgical risk, transcatheter aortic valve implantation (TAVI) is associated with a lower risk of all-cause death or any stroke at one year compared with surgical aortic valve replacement (SAVR).¹

This study was an individual participant data (IPD) meta-analysis of four contemporary, investigator-initiated randomised clinical trials (DEDICATE, NOTION, NOTION-2, and UK TAVI), complemented by an aggregate data meta-analysis that included four industry-sponsored trials. The IPD analysis included 2,873 patients (mean age 76.7 years) with severe symptomatic AS at low- to intermediate-risk who were randomised to either TAVI (n=1,439) or SAVR (n=1,434).¹

The primary endpoint was the composite of all-cause death or any stroke at 1-year post-randomisation. Secondary endpoints included the individual components of the primary endpoint, cardiovascular death, rehospitalisation, myocardial infarction, new-onset atrial fibrillation, new permanent pacemaker implantation, and aortic valve reintervention.¹

In the overall two-stage meta-analysis, which included both IPD and aggregate data, TAVI was associated with a significantly lower risk for the primary endpoint of all-cause death or any stroke at one year (HR 0.76; 95% CI, 0.60–0.97; p=0.03).¹

Analysis of the IPD from the investigator-initiated trials alone showed a 45% relative risk reduction for all-cause death with TAVI compared to SAVR (HR 0.55; 95% CI, 0.38–0.81).¹

Regarding secondary endpoints, TAVI was associated with a lower risk of cardiovascular death (overall HR 0.73; 95% CI, 0.56–0.96) and new-onset atrial fibrillation (overall HR 0.24; 95% CI, 0.16–0.36). However, TAVI was linked to a higher incidence of new permanent pacemaker implantation (overall HR 2.31; 95% CI, 1.35–3.96) and aortic valve reintervention (overall HR 2.10; 95% CI, 1.26–3.48).¹

These findings provide robust evidence supporting the use of TAVI in this patient population. The authors state, "TAVI was associated with a reduction in the 1-year incidence of all-cause death or any stroke. These findings emphasize TAVI as alternative option in patients at low to intermediate risk."¹

The authors highlight that long-term follow-up is necessary to evaluate the sustainability of these findings, particularly concerning valve durability and late reintervention rates, especially in younger patients at very low risk.¹

This study was funded by various sources for the individual trials, including the German Centre for Cardiovascular Research and the National Institute for Health Research.

References

1. Ludwig S, Klimek M, Bay B, et al. Transcatheter or Surgical Treatment of Patients With Aortic Stenosis at Low to Intermediate Risk: An Individual Participant Data Meta-Analysis. JAMA Cardiol. Published online August 30, 2025. https://doi.org/10.1001/jamacardio.2025.3403

2. Blankenberg S, Seiffert M, Vonthein R, et al. Transcatheter or surgical treatment of aortic-valve stenosis. N Engl J Med. 2024;390(17):1572-1583. https://doi.org/10.1056/NEJMoa2400685

The information presented in this article is for educational purposes only. Any quotes included reflect the opinions of the individual quoted, and do not necessarily reflect the views of the publisher. The publisher does not guarantee the accuracy or completeness of the content and accepts no responsibility for any errors, or any consequences arising from its use.