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Meta-Analysis
. 2019 Sep 24;14(9):e0221922.
doi: 10.1371/journal.pone.0221922. eCollection 2019.

Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low and intermediate risk: A risk specific meta-analysis of randomized controlled trials

Fang Fang  1 , Jingjing Tang  2 , Yaqin Zhao  1 , Jialing He  1 , Ping Xu  3 , Andrew Faramand  4
Affiliations
Meta-Analysis

Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low and intermediate risk: A risk specific meta-analysis of randomized controlled trials

Fang Fang et al. PLoS One. .

Abstract

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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Search strategy and final included and excluded studies.
Fig 2
Fig 2. Association of TAVI vs SAVR with a composite of all-cause mortality and disabling stroke, stratified by surgical risk.
TAVI = Transcatheter aortic valve implantation, SAVR = surgical aortic valve replacement, M-H = Mantel-Haenszel.
Fig 3
Fig 3. Interaction between an STS score and survival/stroke benefits with TAVI.
Meta-regression analysis confirmed the positive interaction between an STS score and the benefits of TAVI, with lower STS score with (A) a composite of all-cause mortality and disabling stroke (P = 0.0135), (B) all-cause mortality (P = 0.05), and (C) lower cumulative doses (P = 0.01). STS = Society of Thoracic Surgeons Predicted Risk of Mortality;TAVI = transcatheter aortic valve implantation.
Fig 4
Fig 4. Summary of findings for outcomes in the review, stratified by patients with intermediate and low risk.
TAVI = transcatheter aortic valve implantation; SAVR = surgical aortic valve replacement.
See this image and copyright information in PMC

References

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