Target trial emulation for a two-arm, parallel, stratified pragmatic RCT of CABG versus PCI in people with high-risk characteristics requiring myocardial revascularisation (High-Risk REVASC)
Abstract
Aim: This study aimed to investigate whether treatment effects (TE) for coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) were consistent for people requiring coronary revascularisation with high-risk characteristics.
Methods: We used target trial emulation (TTE) as study design and observational data from Hospital Episode Statistics (HES). The target population was people requiring multivessel coronary revascularisation with at least one of seven high-risk characteristics: age >75 years, female, heart failure, chronic kidney disease, peripheral vascular disease, intermediate frailty risk, or presentation with acute coronary syndrome. The intervention was CABG and the comparison was PCI. Outcomes included all-cause and cardiovascular (CV) mortality, CV hospitalisation, and major adverse cardiovascular events within 5 years of the index procedure. This study included four research stages: (1) latent class analysis (LCA) to identify mutually exclusive patient clusters representing different clinical phenotypes, (2) instrumental variable analysis (IVA) to estimate the TE for the whole population and each patient class; (3) repeating IVA in an emulated trial population obtained by matching a previous cardiac surgery trial enriched for high-risk characteristics to the HES population; (4) co-designed a pragmatic randomised controlled trials (RCT) with multiple stakeholders to address uncertainty identified from the analyses above.
Results: Of…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 103,670 participants or records.
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