Quantitative Flow Ratio– vs Angiography-Guided Percutaneous Coronary Intervention

Importance Whether the association of quantitative flow ratio (QFR)–guided percutaneous coronary intervention (PCI) with long-term outcomes differs according to multivessel disease (MVD) status is uncertain. Objective To assess the association of QFR-guided vs angiography-guided PCI with 3-year outcomes according to MVD status. Design, Setting, and Participants In this prespecified secondary analysis of the FAVOR III China randomized clinical trial, patients were screened across 26 centers in China from December 25, 2018, to January 19, 2020. Eligible participants were adults undergoing PCI for stable or unstable angina or for myocardial infarction (MI) occurring at least 72 hours before screening who had at least 1 lesion with 50% to 90% diameter stenosis in a vessel of 2.5 mm or larger. The analysis compared QFR-guided with angiography-guided PCI according to MVD status. MVD was defined by involvement of at least 2 epicardial vessels or the left main coronary artery. The primary analyses of the current prespecified secondary analysis were completed in October 2024. Interventions Randomization 1:1 to QFR-guided PCI or angiography-guided PCI. Main Outcomes and Measures The primary end point of the FAVOR III China randomized clinical trial was 1-year major adverse cardiac events (MACE), defined as a composite of all-cause death, MI, and ischemia-driven revascularization. The current analysis evaluated 3-year MACE. Results Among 3825 patients in the intention-to-treat population (mean [SD] age, 62.7 [10.0] years; 2699 [70.6%] male), 2066 (54.0%) had MVD. In the MVD cohort, MACE occurred in 124 of 1023 patients (12.1%) in the QFR-guided group and 188 of 1043 patients (18.1%) in the angiography-guided group (hazard ratio, 0.65; 95% CI, 0.52-0.81; P < .001), driven by lower rates of MI and revascularization. In the non-MVD cohort, MACE occurred in 76 of 890 patients (8.6%) and 95 of 869 patients (11.0%), respectively (hazard ratio, 0.77; 95% CI, 0.57-1.04; P = .09). The treatment × MVD interaction was not statistically significant ( P for interaction = .35). The findings of landmark, per-protocol, competing-risk, sensitivity, and hierarchical win-ratio analyses were directionally consistent with the main findings. Conclusions and Relevance In this prespecified secondary analysis of a randomized clinical trial of patients undergoing PCI, QFR-guided PCI was associated with a lower 3-year MACE rate among patients with MVD; however, no significant interaction was observed between treatment effect and MVD status. These findings provide longer-term randomized evidence supporting QFR-guided PCI across MVD strata and warrant further confirmation. Trial Registration ClinicalTrials.gov Identifier: NCT03656848