Early gains, late convergence: clinical and echocardiographic outcomes of TAVR versus SAVR in low-surgical-risk aortic stenosis: a meta-analysis and trial sequential analysis

Background TAVR is established in low-surgical-risk aortic stenosis, but the durability of its clinical benefits and hemodynamic profile across valve platforms remain uncertain. Methods PubMed, Scopus, and Cochrane Library were searched for randomized trials comparing TAVR with surgical aortic valve replacement (SAVR) in low-risk patients. Random-effects meta-analysis assessed clinical outcomes at 30 days, 1 year, and extended follow-up and echocardiographic outcomes at 30 days and 1 year, stratified by prosthesis type. Reconstructed individual patient data were analyzed for time-to-event endpoints, with trial sequential and sensitivity analyses. Results Seven RCTs (n = 5,750; 2,927 TAVR, 2,823 SAVR) were included. At 1 year, TAVR reduced all-cause mortality (RR 0.61, 95% CI 0.44 to 0.84; p = 0.0096), but not at extended follow-up (RR 0.92, 95% CI 0.62 to 1.39; p = 0.65). Reconstructed IPD showed no significant hazard differences for mortality (HR 1.03, 95% CI 0.88 to 1.21; p = 0.70), stroke (HR 0.97, 95% CI 0.74 to 1.28; p = 0.85), or death/disabling stroke (HR 1.01, 95% CI 0.85 to 1.19; p = 0.91). RMST showed small 1-year advantages for mortality (0.1 months; p = 0.003) and death/disabling stroke (0.2 months; p < 0.001), neither sustained at extended follow-up. Major bleeding was lower with TAVR at 30 days, 1 year, and extended follow-up (RR 0.30, 0.32, and 0.32, respectively; all p ≤ 0.0004) and was the only outcome with conclusive trial sequential evidence. New-onset AF was lower with TAVR at 30 days (RR 0.19, 95% CI 0.10 to 0.36; p = 0.0012), 1 year (RR 0.22, 95% CI 0.12 to 0.42; p = 0.0018), and extended follow-up (RR 0.33, 95% CI 0.16 to 0.66; p = 0.0093), whereas pacemaker implantation was higher with TAVR at 30 days (RR 2.40, 95% CI 1.79–3.22; p = 0.0052), 1 year (RR 2.38, 95% CI 1.30–4.35; p = 0.0126), and extended follow-up (RR 2.04, 95% CI 1.57–2.64; p = 0.0005). Stroke, myocardial infarction, and valve reintervention did not differ significantly. Self-expanding valves had lower gradients with TAVR (− 2.10 mmHg), whereas balloon-expandable valves had higher gradients (+ 2.08 mmHg at 30 days; subgroup p < 0.0001). Conclusions TAVR provides a modest, transient mortality benefit with less bleeding but greater pacemaker use; long-term outcomes remain comparable, and major bleeding was the only outcome with conclusive trial sequential evidence.