Outcomes at 5 years in patients with severe aortic stenosis: reviewing current information using the restricted mean...

The information about outcomes at 5 years in patients receiving transcatheter aortic valve replacement (TAVR) has grown. We interpreted the information on this topic using the restricted mean survival time (RMST). The purpose of our study was to summarise the current evidence using an original outcome measure with potential methodological advantages. Four cohorts of patients, previously published in the literature, met our criterion of 5 years of follow-up after the implant; another cohort was identified from a group of controls subjected to surgical replacement of the valve. The estimated values of RMST at 5 years for the 5 patient cohorts were the following (N = number of patients, all time values in years): a) real-world high surgical risk cohort: N = 114, RMST = 3.80; b) real-world cohort treated with Corevalve: N = 309, RMST = 3.79; c) a real-world cohort treated with Sapien: N = 180, RMST = 3.61; d) TAVR arm of a randomized trial in intermediate risk patients: N = 1,011; RMST = 3.73; e) surgical replacement arm of the same trial: N = 1,021, RMST = 3.72. The main result of our analysis based on the RMST is represented by the extreme homogeneity of the outcomes (RMSTs ranging from 3.61 to 3.80 years per patient) that remained virtually constant irrespective of the baseline risk of the patients (intermediate or high risk) and regardless of whether the intervention was transcatheter or by surgical replacement. Last but not least, our analysis showed the good methodological performance of the RMST in this disease condition.