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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

Barili, Fabio; Freemantle, Nicholas; Musumeci, Francesco; Martin, Barbara; Anselmi, Amedeo; Rinaldi, Mauro; Kaul, Sanjay; ... Parolari, Alessandro; + view all (2022) 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. European Journal of Cardio-Thoracic Surgery , 61 (5) pp. 977-987. 10.1093/ejcts/ezab516. Green open access

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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.

Type: Article
Title: 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
Location: Germany
Open access status: An open access version is available from UCL Discovery
DOI: 10.1093/ejcts/ezab516
Publisher version: https://doi.org/10.1093/ejcts/ezab516
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Transcatheter aortic valve replacement, Surgical aortic valve replacement, Follow-up, Aortic valve stenosis
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > Comprehensive CTU at UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
URI: https://discovery.ucl.ac.uk/id/eprint/10145032
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