Key result
TAVI shows no difference in 5-year all-cause mortality vs SAVR in low-risk patients.
Why the study?
While TAVI has shown similar short-term outcomes to SAVR in RCTs, longer-term outcomes for low-risk cohorts are now emerging.
Does transcatheter aortic valve implantation improve all-cause mortality or disabling stroke compared to surgical aortic valve replacement in low-risk patients with aortic valve stenosis?
Meta-Analysis (n=3,557)
Does transcatheter aortic valve implantation improve all-cause mortality or disabling stroke compared to surgical aortic valve replacement in low-risk patients with aortic valve stenosis?
Effect estimate: IRR 1.01 (95% CI 0.88-1.16)
p-value: p=0.88
At 5-year follow-up, TAVI and SAVR show comparable rates of mortality and disabling stroke in low-risk patients with aortic stenosis, though TAVI is associated with higher rates of paravalvular leak and pacemaker implantation.
Supports individualized choice of TAVI or SAVR in low-risk aortic stenosis; confirms long-term mortality equivalence in Level 1 evidence.
OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has shown similar short-term outcomes when compared to surgical aortic valve replacement (SAVR) in randomized controlled trials (RCTs). Longer-term outcomes for low-risk cohorts are now emerging. Here, we analyse all low-risk TAVI versus SAVR RCTs that completed 5-year follow-up. METHODS: A systematic MEDLINE database search was conducted through 6 May 2025, identifying all low-risk RCTs comparing TAVI with SAVR that had completed 5-year follow-up. The primary outcomes were all-cause mortality and the composite of all-cause mortality or disabling stroke. Secondary outcomes included stroke, cardiovascular death, aortic reintervention, myocardial infarction, paravalvular leak, need for permanent pacemaker and postprocedural atrial fibrillation. RESULTS: Four RCTs, including 3557 patients (TAVI: 1829; SAVR: 1728), were analysed. There was no difference between cohorts in all-cause mortality [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI): 0.88-1.16, P = 0.88] or the composite of all-cause mortality or disabling stroke (IRR 1.03, 95% CI: 0.92-1.17, P = 0.59). TAVI was associated with increased risk of mild or greater paravalvular leak (IRR 7.63, 95% CI: 2.82-20.65, P < 0.001) and permanent pacemaker implantation (IRR 2.12, 95% CI: 1.5-2.98, P < 0.001) and a decreased risk of postprocedural atrial fibrillation (IRR 0.44, 95% CI: 0.28-0.71, P < 0.001). CONCLUSIONS: In published RCTs of low-risk cohorts with completed 5-year follow-up, there was no significant difference between TAVI and SAVR neither in overall mortality nor in the composite of mortality and stroke. Valve-related events (paravalvular leaks and pacemaker need) were higher with TAVI, while atrial fibrillation was more common with SAVR.
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Doenst et al. (2025) conducted a meta-analysis in aortic valve stenosis (n=3,557). Transcatheter aortic valve implantation (TAVI) vs. Surgical aortic valve replacement (SAVR) was evaluated on all-cause mortality (IRR 1.01, 95% CI 0.88-1.16, p=0.88). Transcatheter aortic valve implantation showed no significant difference compared to SAVR for all-cause mortality (IRR 1.01; 95% CI 0.88-1.16; P=0.88) at 5 years in low-risk patients.
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