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

Author:

Barili Fabio12ORCID,Freemantle Nicholas3,Musumeci Francesco4,Martin Barbara5,Anselmi Amedeo6ORCID,Rinaldi Mauro7,Kaul Sanjay8,Rodriguez-Roda Jorge9ORCID,Di Mauro Michele10ORCID,Folliguet Thierry11,Verhoye Jean-Philippe6,Sousa-Uva Miguel12,Parolari Alessandro1314ORCID

Affiliation:

1. Department of Cardiac Surgery, S. Croce Hospital, Cuneo, Italy

2. Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA

3. Institute of Clinical Trials and Methodology, University College London, London, UK

4. Department of Heart and Vessels, Cardiac Surgery Unit and Heart Transplantation Center, S. Camillo-Forlanini Hospital, Rome, Italy

5. Department of Research and Third Mission Area, University of Turin, Turin, Italy

6. Division of Thoracic and Cardiovascular Surgery, Pontchaillou University Hospital, Rennes, France

7. Department of Cardiac Surgery, AOU “Città della Salute e della Scienza di Torino”, University of Turin, Turin, Italy

8. Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA, USA

9. Department of Cardiac Surgery, Ramon y Cajal University Hospital, Madrid, Spain

10. Cardiothoracic and Vascular Department, Maastricht University Medical Center, Maastricht, Netherlands

11. Department of Cardiac Surgery, Hôpital Henri Mondor, Paris, France

12. Department of Cardiothoracic Surgery, Hospital de Santa Crux, Carnaxide, Portugal

13. Universitary Cardiac Surgery Unit, IRCCS Policlinico S. Donato, Italy

14. Department of Biomedical Sciences for Health, University of Milan, Milan, Italy

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.

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine,Pulmonary and Respiratory Medicine,General Medicine,Surgery

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