Time-to-event analysis of the long-term outcome in trials comparing transcatheter and surgical aortic valve implantation: A meta-analysis.

OBJECTIVE: Indications for TAVI have been widened, although long-term device efficacy is still unclear. We aimed to compare the effectiveness of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) on a composite of death from any cause or stroke at 5-year follow-up according to risk profiles. METHODS: We performed a systematic literature review for randomized control trials (RCTs) comparing TAVI or SAVR. The primary endpoint was the composite of all-cause mortality or stroke at follow-up. Hazard ratios (HRs) and restricted mean survival time (RMST) differences within high, intermediate and low-risk profiles were estimated by reconstructing time-to-event data from these Kaplan-Meier curves. RESULTS: Eight trials were included (9811 participants). The incidence of composite endpoint increased concordantly with higher baseline risk profiles for both treatments. A time-variant effect was present with transcatheter superior to surgery early, as supported by a cumulative additional time-to-event of 0.77 months at 4 years driven by the high-risk group that is attenuated at 60 months. The benefit of the transcatheter approach increased over time up to 5 years in high-risk patients (RMST difference = 2.39; 95 %CI = -0.23;5.02; p-value = 0.07), while the benefit of the transcatheter approach in intermediate and low-risk patients showed a quadratic association with a smaller increase and attenuation of the observed benefit after 60 months postintervention (low-risk = 0.86; 95 %CI = -0.11,1.84; p-value 0.09; intermediate = 0.45; 95 %CI = -0.66;1.56; p-value = 0.42). CONCLUSIONS: Although an initial benefit of TAVI over SAVR, there are no significant differences at 5 years follow-up independently from the risk profile.