Key considerations in a meta-analysis of physiology-guided percutaneous vs surgical revascularization in multivessel coronary artery disease

Abstract

We read the meta-analysis by Kataveni et al with great interest; however, we have identified two major methodological errors. First, the population from the Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3 (FAME 3) trial appears to have been double-counted through inclusion of both Fearon et al (primary FAME 3 trial) and Dillen et al (a FAME 3 bifurcation substudy), likely violating the independence assumptions required for meta-analytic pooling. Second, the study by Di Gioia et al (2020) has been misclassified as a randomized controlled trial, whereas it is a registry-based, non-randomized study. Because the authors’ conclusions rely on the inclusion of “three randomized controlled trials” with minimal heterogeneity, these errors may overstate the certainty of the evidence and introduce bias into the pooled estimates. We request that the authors address these concerns, perform a re-analysis as required, and revise the manuscript accordingly. Ultimately, these issues reflect the general paucity of high-quality randomized data in this field.

Keywords: Fractional flow reserve; Percutaneous coronary intervention; Coronary artery bypass grafting; Randomized controlled trial; Meta-analysis

Core Tip: The recent meta-analysis by Kataveni et al was timely in a field with scarce randomized data. However, the authors appear to have included two manuscripts derived from the same Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3 population and misclassified the registry-based study by Di Gioia et al as a randomized trial. These issues warrant further clarification and underscore the need for future editorial and peer-review oversight in this area.