COMPARISON OF SAVR VERSUS TAVR 5-YEAR MORTALITY IN REAL- WORLD SCENARIOS.

Purpose: While Randomized clinical trials (RCTs) are designed to provide evidence of efficacy, real world data (RWD) shows actual effectiveness. We designed a systematic review and meta-analysis of reconstructed time-to-event data (RTE) from propensity score matching studies comparing the effectiveness of TAVR vs SAVR to assess differences in 5-year mortality. Methods: Using MEDLINE, Embase and CENTRAL databases from 2007 to 2023, we performed a systematic review of the literature including propensity score matching studies comparing TAVR and SAVR. The primary endpoint was the composite of all-cause mortality at follow- up. The Hazard Ratio (HR) was considered as the effect size. Results: Twenty-one studies were included (39538 participants). TAVR showed a higher incidence of all-cause mortality (HR 1.39; 95% CI 1.33 – 1.46, p-value < 0.001), with a significant heterogeneity (random parameter θ = 0.85, p-value < 0.001). The analysis of HR trend over time showed that TAVR superiority to surgery is limited to the first month with a steep reversal afterwards. All-cause mortality in low-risk was significantly higher in TAVR (HR 1.33; 95% CI 1.06 – 1.67, p-value < 0.001). The HR trend in the low-risk group differed from the whole population as there was no advantage of TAVR. Conclusions: In real-word settings TAVR is associated with a significantly higher incidence of all-cause of death while maintaining a survival benefit only in the first month after implantation. These results indicate that TAVR effectiveness may not reflect the efficacy demonstrated by RCTs and pose a serious threat to their external validity.