Bayesian interpretation of non-inferiority in transcatheter versus surgical aortic valve replacement trials: a systematic review and meta-analysis
A systematic search was applied to 3 electronic databases …
Systematic Review, Meta-analysis, Randomised Trial
Abstract
The concept of non-inferiority is widely adopted in randomized trials comparing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). However, uncertainty exists regarding the long-term outcomes of TAVR, and non-inferiority may be difficult to assess. We performed a systematic review and meta-analysis of randomized trials comparing TAVR and SAVR, with a specific emphasis on the non-inferiority margin for 5-year all-cause mortality. A systematic search was applied to 3 electronic databases.
Randomized trials comparing TAVR and SAVR were included. Bayesian methods were implemented to evaluate the posterior probability of non-inferiority at different trial non-inferiority margins under either a vague, Cauchy, or a literature-based prior. Primary outcomes were 5-year actuarial all-cause mortality, and the probability of non-inferiority at various transformed trial non-inferiority margins. Secondary outcomes were long-term survival and 1- and 2-year actuarial survival.
Eight trials (\(n=8698\) patients) were included. Kaplan–Meier-derived \(5\)-year survival was \(61.6\%\) (\(95\%\) CI \(59.8–63.5\%\)) for TAVR, and \(63.7\%\) (\(95\%\) CI \(61.9–65.6\%\)) for SAVR. Six trials (\(n=6370\) patients) reported all-cause mortality at \(5\)-year follow-up. Under a vague prior, the posterior median relative risk for all-cause mortality of TAVR was \(1.14\), compared to SAVR (95% credible interval \(1.06-1.22\), probability of relative risk \(<1.00=0.01\%\), I2 \(= 0\%\)). Similar results in terms of point estimate and uncertainty measures were obtained using frequentist methods. Based on the various trial non-inferiority margins, the results of the analysis suggest that non-inferiority at \(5\)-years is no longer likely.
Citation
@online{gabrio2023,
author = {Gabrio, Andrea},
title = {Bayesian Interpretation of Non-Inferiority in Transcatheter
Versus Surgical Aortic Valve Replacement Trials: A Systematic Review
and Meta-Analysis},
volume = {37},
number = {5},
date = {2023-07-05},
url = {https://academic.oup.com/icvts/article/37/5/ivad185/7429399},
doi = {10.1093/icvts/ivad185},
langid = {en},
abstract = {{[}A systematic search was applied to 3 electronic
databases ...{]}\{style=“font-size: 85\%”\}}
}