Fabio Barili1, Nicholas Freemantle2, Alberto Pilozzi Casado1, Mauro Rinaldi3, Thierry Folliguet4, Francesco Musumeci5, Gino Gerosa6, Alessandro Parolari7. 1. Department of Cardiac Surgery, S. Croce Hospital, Cuneo, Italy. 2. Department of Primary Care and Population Health, University College London, London, UK. 3. Department of Cardiac Surgery, AOU "Città della Salute e della Scienza di Torino", University of Turin, Turin, Italy. 4. Department of Cardiac Surgery, Hôpital Henri Mondor, Paris, France. 5. Department of Heart and Vessels, Cardiac Surgery Unit and Heart Transplantation Center, S. Camillo-Forlanini Hospital, Rome, Italy. 6. Department of Cardiac Surgery, University of Padua, Padua, Italy. 7. Unit of Cardiac Surgery and Translational Research, IRCCS Policlinico S. Donato, University of Milan, Milan, Italy.
Abstract
OBJECTIVES: This meta-analysis of Kaplan-Meier-estimated individual patient data was designed to evaluate the effects of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) on the long-term all-cause mortality rate, to examine the potential time-varying effect and to model their hazard ratios (HRs) over time. Moreover, we sought to compare traditional meta-analytic tools and estimated individual patient data meta-analyses. METHODS: Trials comparing TAVI versus SAVR were identified through Medline, Embase, Cochrane databases and specialist websites. The primary outcome was death from any cause at follow-up. Enhanced secondary analyses of survival curves were performed estimating individual patient time-to-event data from published Kaplan-Meier curves. Treatments were compared with the random effect Cox model in a landmark framework and fully parametric models. RESULTS: We identified 6 eligible trials that included 6367 participants, randomly assigned to undergo TAVI (3252) or SAVR (3115). According to the landmark analysis, the incidence of death in the first year after implantation was significantly lower in the TAVI group [risk-profile stratified HR 0.85, 95% confidence interval (CI) 0.73-0.99; P = 0.04], whereas there was a reversal of the HR after 40 months (risk-profile stratified HR 1.31, 95% CI 1.01-1.68; P = 0.04) favouring SAVR over TAVI. This time-varying trend of HRs was also confirmed by a fully parametric time-to-event model. Traditional meta-analytic tools were shown to be biased because they did not intercept heterogeneity and the time-varying effect. CONCLUSIONS: The mortality rates in trials of TAVI versus SAVR are affected by treatments with a time-varying effect. TAVI is related to better survival in the first months after implantation whereas, after 40 months, it is a risk factor for all-cause mortality.
OBJECTIVES: This meta-analysis of Kaplan-Meier-estimated individual patient data was designed to evaluate the effects of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) on the long-term all-cause mortality rate, to examine the potential time-varying effect and to model their hazard ratios (HRs) over time. Moreover, we sought to compare traditional meta-analytic tools and estimated individual patient data meta-analyses. METHODS: Trials comparing TAVI versus SAVR were identified through Medline, Embase, Cochrane databases and specialist websites. The primary outcome was death from any cause at follow-up. Enhanced secondary analyses of survival curves were performed estimating individual patient time-to-event data from published Kaplan-Meier curves. Treatments were compared with the random effect Cox model in a landmark framework and fully parametric models. RESULTS: We identified 6 eligible trials that included 6367 participants, randomly assigned to undergo TAVI (3252) or SAVR (3115). According to the landmark analysis, the incidence of death in the first year after implantation was significantly lower in the TAVI group [risk-profile stratified HR 0.85, 95% confidence interval (CI) 0.73-0.99; P = 0.04], whereas there was a reversal of the HR after 40 months (risk-profile stratified HR 1.31, 95% CI 1.01-1.68; P = 0.04) favouring SAVR over TAVI. This time-varying trend of HRs was also confirmed by a fully parametric time-to-event model. Traditional meta-analytic tools were shown to be biased because they did not intercept heterogeneity and the time-varying effect. CONCLUSIONS: The mortality rates in trials of TAVI versus SAVR are affected by treatments with a time-varying effect. TAVI is related to better survival in the first months after implantation whereas, after 40 months, it is a risk factor for all-cause mortality.
Authors: Hatem Al-Farra; Bas A J M de Mol; Anita C J Ravelli; W J P P Ter Burg; Saskia Houterman; José P S Henriques; Ameen Abu-Hanna; M M Vis; J Vos; L Timmers; W A L Tonino; C E Schotborgh; V Roolvink; F Porta; M G Stoel; S Kats; G Amoroso; H W van der Werf; P R Stella; P de Jaegere Journal: Int J Cardiol Heart Vasc Date: 2021-01-23
Authors: Victor Dayan; Ovidio A Garcia-Villarreal; Alejandro Escobar; Javier Ferrari; Eduard Quintana; Mateo Marin-Cuartas; Rui M S Almeida Journal: Braz J Cardiovasc Surg Date: 2021-08-06
Authors: Stephanie Louise Swift; Thomas Puehler; Kate Misso; Shona Helen Lang; Carol Forbes; Jos Kleijnen; Marion Danner; Christian Kuhn; Assad Haneya; Hatim Seoudy; Jochen Cremer; Norbert Frey; Georg Lutter; Robert Wolff; Fueloep Scheibler; Kai Wehkamp; Derk Frank Journal: BMJ Open Date: 2021-12-06 Impact factor: 2.692