Transcatheter Versus Surgical Aortic Valve Replacement for Severe Aortic Valve Stenosis: Meta-Analysis with Trial Sequential Analysis

Randomized controlled trials (RCTs) comparing transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) demonstrate conflicting evidence, particularly in low-risk patients. We aim to reevaluate the evidence using Trial Sequential Analysis (TSA), balancing type I and II errors, and compare to conventional meta-analysis (cMA).Databases were searched for RCTs, which were divided into higher-risk and lower-risk RCTs according to a pragmatic risk classification. Primary outcomes were death, and a composite endpoint of death or disabling stroke assessed at 1 year and maximum follow-up. cMA and TSA were performed, and the required information size (RIS) was calculated considering a type I error of 5% and a power of 90%.Eight RCTs (n=5274 higher-risk and 3661 lower-risk patients) were included. Higher-risk trials showed no significant reduction in death at 1 year with TAVI (RR 0.93, 95% CI: 0.81-1.08, P=0.345). Lower-risk trials suggested lower death risk on cMA (RR 0.67, 95% CI: 0.47-0.96, P=0.031), but TSA indicated potential spurious evidence (P=0.116), necessitating more data for conclusive benefit (RIS=5944 [59.8%]). For death or disabling stroke at 1 year, higher-risk trials lacked evidence (RR 0.90, 95% CI: 0.79-1.02, P=0.108). In lower-risk trials, TAVI indicated lower risk in cMA (RR 0.68, 95% CI: 0.50-0.93, P=0.014), but TSA suggested potential spurious evidence (P=0.053), necessitating more data for conclusive benefit (RIS=5122 [69.4%]). Follow-up results provided inconclusive evidence for both primary outcomes across risk categories.cMA methods may have prematurely declared an early reduction of negative outcomes following TAVI when compared with SAVR.