Transcatheter vs Surgical Aortic Valve Replacement in Lower-Risk Patients: An Updated Meta-Analysis of Randomized Controlled Trials.

Background: Longer-term outcomes are especially important for lower-risk patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Additional randomized data comparing TAVR and SAVR have recently become available.

Objectives: The purpose of this study was to perform an updated systematic review with conventional pairwise meta-analyses and pooled survival analyses using reconstructed time-to-event individual participant data (IPD) including the totality of randomized evidence comparing longer-term clinical outcomes after TAVR and SAVR in lower-risk patients.

Methods: The prespecified primary endpoint was all-cause death. Key secondary endpoints included stroke and the composite of death or disabling stroke. Cox proportional hazards frailty regression and restricted mean survival time models were fitted using reconstructed time-to-event IPD. In sensitivity analyses, proportional odds models were fitted with frailty terms. Conventional pairwise meta-analyses were performed under random and fixed effects assumptions.

Results: Six trials enrolling 5,341 lower-risk patients were included with 2,717 randomized to TAVR and 2,624 randomized to SAVR (weighted mean follow-up of 35.7 months). At 5 years in the pooled survival analyses of reconstructed time-to-event IPD, TAVR was associated with a 20% reduction in the hazard of all-cause death (HR: 0.80; 95% CI: 0.66-0.97; P = 0.02) and a 19% reduction in the hazard of all-cause death or disabling stroke (HR: 0.81; 95% CI: 0.68-0.96; P = 0.01) compared with SAVR. There was no difference in stroke (HR: 0.97; 95% CI: 0.74-1.26; P = 0.80).

Conclusions: In lower-risk patients, TAVR was associated with a reduced hazard of death and death or disabling stroke compared with SAVR, while rates of stroke were equivalent. Most patients have not yet undergone 5-year follow-up, and so these findings may change as further longer-term data become available. The present data are informative for lower-risk patients and treating clinicians, but further randomized trials and longer-term follow-up are required, particularly in younger patients.