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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Barili Fabio, Freemantle Nicholas, Musumeci Francesco, Martin Barbara, Anselmi Amedeo, Rinaldi Mauro, Kaul Sanjay, Rodriguez-Roda Jorge, Di Mauro Michele, Folliguet Thierry, Verhoye Jean-Philippe, Sousa-Uva Miguel, Parolari Alessandro, Latin European Alliance of CardioVascular Surgical Societies (LEACSS) and with the endorsement of the Latin American Association of Cardiac and Endovascular Surgery (LACES), LEACSS members are the Italian Society of Cardiac Surgery (FB FM MR MdM AP), the Portuguese Society of Cardiac Surgery (MSU), the French Society of Cardiac Surgery (JFV, AA) and the Spanish Society of Cardiac Surgery (JRR) Institutions
Аннотация
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.