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November 23, 2021European Journal of Cardio-Thoracic Surgery41 citationsOpen Access

Five-year outcomes in trials comparing transcatheter aortic valve implantation versus surgical aortic valve replacement: a pooled meta-analysis of reconstructed time-to-event data

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FBFabio BariliNFNicholas FreemantleFMFrancesco Musumeci

Structured PICO

Does transcatheter aortic valve implantation (TAVI) improve long-term outcomes compared to surgical aortic valve replacement (SAVR) in patients requiring aortic valve replacement?

P
Population
7,770 participants pooled from 7 randomized trials comparing TAVI and SAVR with at least 1-year follow-up
I
Intervention
Transcatheter aortic valve implantation (TAVI)
C
Comparator
Surgical aortic valve replacement (SAVR)
O
Outcome
Composite of death or strokecomposite

While TAVI offers a short-term protective effect against death or stroke compared to SAVR, it is associated with a higher risk of mortality, stroke, and rehospitalization after 2 years.

Abstract

Abstract OBJECTIVES The incidence of outcomes in trials comparing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) is expected to be different in the short and long term. We planned a meta-analysis of reconstructed time-to-event data from trials comparing TAVI and SAVR to evaluate their time-varying effects on outcomes. METHODS We performed a systematic review of the literature from January 2007 through September 2021 on Medline, Embase, the Cochrane Central Register of Controlled Trials and specialistic websites, including randomized trials with allocation to TAVI or SAVR that reported at least 1-year follow-up and that graphed Kaplan–Meier curves of end points. The comparisons were done with grouped frailty Cox models in a landmark framework and fully parametric models. RESULTS Seven trials were included (7770 participants). TAVI showed a lower incidence of the composite of death or stroke in the first 6 months risk-stratified hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.56–0.77, P-value 0.001, with an HR reversal after 24 months favouring SAVR (risk-stratified HR 1.25; 95% CI 1.08–1.46; P-value 0.003). These outcomes were confirmed for all-cause death (risk-stratified HR after 24 months 1.18; 95% CI 1.03–1.35; P-value 0.01). TAVI was also associated with an increased incidence of rehospitalization after 6 months (risk-stratified HR 1.42; 95% CI 1.06–1.91; P-value 0.018) that got worse after 24 months (risk-stratified HR 1.67; 95% CI 1.24–2.24; P-value 0.001). CONCLUSIONS Although it could appear that there is no difference between TAVI and SAVR in the 5-year cumulative results, TAVI shows a strong protective effect in the short term that runs out after 1 year. TAVI becomes a risk factor for all-cause mortality and the composite end point after 24 months and for rehospitalization after 6 months.

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Cite This Study

Barili et al. (2021) studied this question.

synapsesocial.com/papers/6995afa058b439db10ff77b2https://doi.org/10.1093/ejcts/ezab516
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