Data simulation to forecast the outcomes of the FAVOR III China trial.

Abstract

FAVOR III China (F3C) is a large-scale randomized trial comparing QFR-guided and angiography-guided percutaneous coronary intervention (PCI) strategies. The aim of current study was to assess the feasibility of predicting the 1-year outcomes of the F3C trial using simulation of retrospectively assessed quantitative flow ratio (QFR) data obtained from the all-comers PANDA III trial. Among 2348 subjects from the PANDA III trial, angiography from 1391 patients was able to be analyzed with QFR. Each subject from the F3C was matched to a PANDA III patient according to the five baseline characteristics (age, sex, diabetes, multivessel disease, and existence of any vessel with diameter stenosis %>90% and thrombolysis in myocardial infarction flow<3) through a bootstrapping sampling process. Outcome predictions were based on these blinded baseline data. The primary endpoint was a composite of death, myocardial infarction, or revascularization at 1 year. Among the patients with analyzable QFR, 814 patients were able to be matched to F3C patients undergoing a QFR-guided treatment strategy. After 10,000 simulations, the patients in the QFR-guided group were simulated to have a 1.9% (95% predictive intervals: -3.5% to -0.3%) absolute reduction of the occurrence of the primary study endpoint compared with the angiography-guided group. In total, 72.7% (7266/10,000) simulated point estimates fell within the actual 95% CI of F3C (-4.7% to -1.4%). Using a simulation process based on a comparison to an existing trial cohort, the primary results of a prospectively conducted randomized controlled trial could be predicted with reasonable precision.