Transcatheter versus surgical aortic valve replacement in low- to intermediate-risk patients: a meta-analysis of reconstructed time-to-event data.

Abstract

Background: Transcatheter aortic valve replacement (TAVR) is an established alternative to surgical aortic valve replacement (SAVR) for severe symptomatic aortic stenosis (AS), including low-risk patients. We aimed to update a systematic review and conduct a meta-analysis of reconstructed time-to-event data from randomized control trials (RCTs) in low-/intermediate-risk patients.

Methods: Systematic searches were performed in PubMed, EMBASE, Cochrane CENTRAL, and specific websites up to November 2023, for RCTs. A meta-analysis was performed using the reconstructed time-to-event data from the provided Kaplan-Meier (KM) curves from the included RCTs. The primary outcome was all-cause mortality, and the secondary outcomes included a composite outcome (all-cause mortality and disabling stroke), and heart failure rehospitalization. Landmark analysis for endpoints beyond 1 year was performed. The study protocol was registered on PROSPERO (CRD42023487893).

Results: Six RCTs with a total of 7,389 patients were included. The survival was comparable between both groups [hazard ratio (HR), 1.03; 95% confidence interval (CI): 0.93-1.14; P=0.57]. The composite outcome and heart failure rehospitalization were comparable between the two groups. Lower mortality with TAVR was observed compared to SAVR before 1 year (HR, 0.82; 95% CI: 0.68-0.98; P=0.03), while TAVR was associated with higher risk of mortality beyond 1 year (HR, 1.13; 95% CI: 1.01-1.27; P=0.04). Similarly, the TAVR group was associated with lower risk for the composite endpoint and heart failure rehospitalization before 1 year, but with higher rates beyond 1 year.

Conclusions: Among low- to intermediate-risk patients, TAVR was found to be associated with favorable outcomes in the short-term (0-1 year). However, our landmark analysis demonstrated TAVR to be associated with poorer outcomes beyond 1 year.