In patients with severe aortic stenosis at low surgical risk, TAVI significantly reduced the composite of all-cause mortality or disabling stroke at 12 months compared to SAVR (RR 0.56), though this benefit was not seen in intermediate-risk patients.
Meta-Analysis (n=6,390)
Unblinded
Yes
Does transcatheter aortic valve implantation reduce the composite of all-cause mortality or disabling stroke compared to surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate surgical risk?
TAVI provides superior clinical outcomes compared to SAVR in low-risk patients with severe aortic stenosis, but performs similarly to SAVR in intermediate-risk patients.
Effect estimate: RR 0.56 (95% CI 0.40-0.79)
Absolute Event Rate: 2.8% vs 5.1%
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an option for treatment for patients with severe aortic stenosis who are at high risk for death with surgical aortic valve replacement (SAVR). It is unknown whether TAVI can be safely introduced to intermediate- and low-risk patients. OBJECTIVE: To compare the efficacy and safety of TAVI and SAVR in patients with intermediate- and low-surgical risk. DATA SOURCES: Medline, Embase, and the Cochrane Central Register of Controlled Trials were searched from inception to April 15, 2019. STUDY SELECTION: We included randomized controlled trials comparing TAVI with SAVR in patients with intermediate- and low-surgical risk. DATA EXTRACTION: Meta-analyses were conducted using random-effects models to calculate risk ratios (RR) with corresponding 95% confidence interval (CI). Two independent reviewers completed citation screening, data abstraction, and risk assessment. Primary outcome was a composite of all-cause mortality or disabling stroke at 12 months. DATA SYNTHESIS: A total of 5 trials randomizing 6390 patients were included. In patients with low risk, TAVI was associated with a significant reduction in the composite of all-cause mortality or disabling stroke compared with SAVR (RR, 0.56; 95%CI, 0.40-0.79; I2 = 0%). This benefit was not replicated in patients with intermediate risk (RR, 0.96; 95% CI, 0.80-1.15; I2 = 0%). Similar results were seen separately in all-cause mortality and disabling stroke when TAVI was compared with SAVR. CONCLUSION: For patients with severe aortic stenosis who were at low risk for death from surgery, TAVI achieved superior clinical outcomes compared to SAVR; however, these benefits were not seen in those with intermediate risk. This information may inform discussions about deciding between SAVR and TAVI for patients with low to intermediate risk separately.
Fang et al. (2019) conducted a meta-analysis in Severe aortic stenosis in patients at low and intermediate surgical risk (n=6,390). Transcatheter aortic valve implantation (TAVI) vs. Surgical aortic valve replacement (SAVR) was evaluated on Composite of all-cause mortality or disabling stroke at 12 months (low-risk subgroup) (RR 0.56, 95% CI 0.40-0.79). In patients with severe aortic stenosis at low surgical risk, TAVI significantly reduced the composite of all-cause mortality or disabling stroke at 12 months compared to SAVR (RR 0.56), though this benefit was not seen in intermediate-risk patients.