Updated 5-year outcomes of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low- to intermediate-surgical risk.

Objectives The comparative long-term safety and efficacy of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) remains under continued investigation, particularly in patients at low- to intermediate-surgical risk. This study aims to synthesise and update contemporary long-term TAVI versus SAVR data.Methods This study comprised a systematic review and meta-analysis and employed a Bayesian hierarchical design. Randomised controlled trials (RCTs) comparing TAVI to SAVR in low-risk to intermediate-risk patients with at least 5-year follow-up were included. The primary outcome was 5-year all-cause mortality; secondary outcomes were the 5-year incidence of stroke and the 5-year incidence of the composite of mortality and stroke.Review Methods Time-to-event data were reconstructed. Relative risks (RRs) with 95% credible intervals (CrIs) were estimated from reported 5-year event rates using minimally informative priors. Sensitivity analyses were performed using various meta-analytical models, and using conventional frequentist random-effects and fixed-effects models for sensitivity purposes.Results A total of six RCTs, enrolling 7249 low- to intermediate-risk patients reported 5-year outcomes (TAVI n=3704, SAVR n=3545). The 5-year all-cause mortality rate was 29.7% (28.2-31.2%, TAVI) and 27.6% (26.1-29.1%, SAVR). The median RR for all-cause mortality was 1.12 (95% CrI 1.02-1.22, heterogeneity τ2=0), with a 99.3% posterior probability that SAVR is superior to TAVI for this endpoint. For stroke, the median RR was 1.13 (95% CrI 0.93-1.39, heterogeneity τ2=0.04), resulting in an 88.0% posterior probability that SAVR outperformed TAVI for this outcome. These results were consistent across conventional frequentist random-effects and fixed-effects models employing p values (RR 1.13, 95% CI 1.05 to 1.22, p=0.001, and RR 1.12, 95% CI 1.03 to 1.23, p=0.011, respectively). There was no evidence for an interaction effect of surgical risk category (p=0.470).Conclusion In this meta-analysis of RCTs, TAVI resulted in a clinically relevant increase in all-cause mortality, and a high probability of an increased risk of stroke, at 5 years of follow-up in low-risk to intermediate-risk patients, when compared to SAVR.