JAMA Cardiol. 2025 Aug 30. doi: 10.1001/jamacardio.2025.3403. Online ahead of print.
ABSTRACT
IMPORTANCE: Mounting evidence suggests transcatheter aortic valve implantation (TAVI) as preferred treatment for patients at low to intermediate surgical risk. However, limitations in study design and statistical power raise concerns about the generalizability of individual randomized clinical trials (RCTs) comparing TAVI and surgical aortic valve replacement (SAVR) to routine clinical practice.
OBJECTIVE: To compare 1-year outcomes of TAVI vs SAVR in patients with severe symptomatic aortic stenosis at low to intermediate surgical risk applying a 2-stage individual participant data (IPD) and aggregate meta-analyses.
DATA SOURCES: MEDLINE databases were searched for RCTs comparing TAVI and SAVR in patients with aortic stenosis until June 15, 2025.
STUDY SELECTION: RCTs were selected comparing TAVI vs SAVR in patients with severe symptomatic aortic stenosis at low or intermediate surgical risk with 1-year follow-up.
DATA EXTRACTION AND SYNTHESIS: IPD were obtained from all investigator-initiated RCTs (DEDICATE, NOTION, NOTION-2, and UK TAVI) and analyzed in 1- and 2-stage IPD meta-analyses. An overall meta-analysis was performed by adding aggregate data from industry-sponsored RCTs.
MAIN OUTCOMES AND MEASURES: The primary end point was all-cause death or any stroke 1 year after randomization. Secondary end points included all-cause death, any stroke, disabling stroke, cardiovascular death, rehospitalization for cardiovascular cause, myocardial infarction, new-onset atrial fibrillation, new permanent pacemaker implantation, and aortic valve reintervention.
RESULTS: The IPD meta-analysis included 4 RCTs comprising 2873 patients (mean [SD] age, 76.7 [5.5] years; 805 [56.1%] male) at low to intermediate surgical risk randomly assigned to TAVI (n = 1439) or SAVR (n = 1434). At 1 year, the hazard ratio (HR) for the primary end point for TAVI compared to SAVR was 0.73 (95% CI, 0.56-0.95) in the 1-stage and 0.79 (95% CI, 0.49-1.27) in the 2-stage IPD meta-analysis. In the 2-stage overall meta-analysis the HR for the primary end point was 0.76 (95% CI, 0.60-0.97).
CONCLUSIONS AND RELEVANCE: In this IPD meta-analysis of 4 RCTs, and an overall meta-analysis of 8 RCTs of patients with severe symptomatic AS at low to intermediate risk, 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. Long-term follow-up is warranted to evaluate sustainability of these findings.
PMID:40884787 | DOI:10.1001/jamacardio.2025.3403
