TY - JOUR
T1 - Five-year outcomes in trials comparing transcatheter aortic valve implantation versus surgical aortic valve replacement
T2 - a pooled meta-analysis of reconstructed time-to-event data
AU - Barili, Fabio
AU - Freemantle, Nicholas
AU - Musumeci, Francesco
AU - Martin, Barbara
AU - Anselmi, Amedeo
AU - Rinaldi, Mauro
AU - Kaul, Sanjay
AU - Rodriguez-Roda, Jorge
AU - Di Mauro, Michele
AU - Folliguet, Thierry
AU - Verhoye, Jean-Philippe
AU - Sousa-Uva, Miguel
AU - Parolari, Alessandro
N1 - © The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
PY - 2022/5/2
Y1 - 2022/5/2
N2 - 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.
AB - 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.
KW - Transcatheter aortic valve replacement
KW - Surgical aortic valve replacement
KW - Follow-up
KW - Aortic valve stenosis
KW - RANDOMIZED-TRIALS
U2 - 10.1093/ejcts/ezab516
DO - 10.1093/ejcts/ezab516
M3 - Article
C2 - 34918068
SN - 1010-7940
VL - 61
SP - 977
EP - 987
JO - European Journal of Cardio-Thoracic Surgery
JF - European Journal of Cardio-Thoracic Surgery
IS - 5
M1 - ezab516
ER -