TIME-TO-EVENT ANALYSIS OF MORTALITY AND STROKE IN TRIALS COMPARING TRANS-CATHETER AND SURGICAL AORTIC VALVE IMPLANTATION WITH DIFFERENT RISK PROFILES.

Background: We compared the effectiveness of TAVI versus SAVR on a composite of death or stroke at 5-year follow-up within high, intermediate and low-risk profiles. Methods: From January 2007 to January 2024, we performed a systematic review of literature including randomized control trials (RCTs) comparing TAVI or SAVR with a minimum 1-year follow-up and reporting Kaplan-Meier analysis. The primary endpoint was the composite of all-cause mortality or stroke. 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. Results: Seven trials were included (8418 participants). The incidence of composite endpoints increased with higher baseline risk profiles for both treatments. A time-variant effect was present with an early superiority of TAVI, as supported by a cumulative additional time-to-event of 0.73 months at 4 years driven by the high-risk group. The benefit of TAVI increased over time up to 5 years in high-risk patients (RMST difference 2.495. 95%CI: -0.019; 5.01. P-value 0.05). In intermediate and low-risk patients it showed a quadratic association with a smaller increase and attenuation of the observed benefit after 60 months (Low risk 0.813, 95%CI -0.177 1.802; p-value 0.107. Intermediate risk 0.076, 95%CI -1.131 1.282, p-value 0.902). Conclusions: In RCTs comparing TAVI vs SAVR, the benefits of TAVI differ according to the patient’s risk category. The advantage of TAVI over surgery progressively increases up to 5 years in high-risk patients. At 5 years in low and intermediate-risk there are no significant observed benefits.