Abstract

Background: We performed a meta-analysis of reconstructed time-to-event data from randomized controlled trials (RCTs) and propensity-score matched (PSM) studies comparing transcatheter versus surgical aortic valve replacement (TAVR versus SAVR) to evaluate mid-term outcomes in patients considered low risk for SAVR. Methods and Results: Study-level meta-analysis of Kaplan-Meier-derived time-to-event of RCTs and PSM studies published by December 31, 2022. Eight studies (3 RCTs; 5 PSM studies) met our eligibility criteria and included 5,444 patients (2,639 patients underwent TAVR and 2,805 patients underwent SAVR). TAVR showed a higher risk of all-cause mortality at 8 years of follow-up [hazard ratio (HR) 1.22, 95% confidence interval (CI) 1.03-1.43, P=0.018]. Up to 2 years of follow-up, TAVR was not inferior to SAVR (HR 1.08, 95%CI 0.89-1.31, P=0.448); however, we observed a statistically significant difference after 2 years with higher mortality with TAVR (HR 1.51; 95% CI 1.14-2.00; P=0.004). This difference was driven by PSM studies; our sensitivity analysis showed a statistically significant difference between TAVR and SAVR when we included only PSM studies (HR 1.41, 95%CI 1.16-1.72, P=0.001), but no statistically significant difference when we included only RCTs (HR 0.89, 95%CI 0.69-1.16, P=0.398). At 8 years of follow-up after the primary intervention, the treatment difference in restricted mean survival time (RMST) is statistically significant, resulting in a benefit of 187.2 days (95% CI, 85.1-289.2, P<0.001) in the SAVR arm. Conclusion: In comparison with TAVR, SAVR appeared to be associated with improved survival beyond 2 years in low-risk patients. However, the survival benefit of SAVR was only observed in PSM studies and not in RCTs. The addition of data from ongoing RCTs as well as longer follow-up in previous RCTs will help to confirm if there is a difference in mid- and long-term survival between TAVR vs. SAVR in low-risk population.

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