Clinical outcomes of deferred lesions by IVUS versus FFR-guided treatment decision: the FLAVOUR trial substudy

Abstract

Abstract Background There is limited data regarding the safety of deferral of percutaneous coronary intervention (PCI) based on intravascular ultrasound (IVUS) findings. Current study sought to compare the prognosis between deferred lesions based on IVUS and FFR (fractional flow reserve)-guided treatment decision. Methods Study population was derived from FLAVOUR trial which is a multinational, open-label, randomized, and non-inferiority trial that compared 2-year clinical outcomes between IVUS and FFR-guided treatment decision using predefined criteria. In both IVUS and FFR groups, vessels were classified into deferred or revascularized vessels, and patients into those with or without deferred lesion. Vessel-oriented composite outcomes (VOCO) (cardiac death, target-vessel myocardial infarction, or target-vessel revascularization) in deferred vessels and patient-oriented composite outcomes (POCO) (death, myocardial infarction, or any revascularization) in patients with deferred lesion were compared between IVUS and FFR group. Results A total of 1682 patients and 1820 vessels were analyzed. At 2 years, there is no difference in cumulative incidence of VOCO in deferred vessels between IVUS and FFR groups (3.8% vs. 4.1%; hazard ratio [HR] 0.91; 95% confidence interval [CI] 0.47-1.75; P=0.771). The risk of VOCO was comparable between deferred and revascularized vessels following both IVUS (3.8% vs. 3.5%; HR 1.09; 95% CI 0.54-2.19; P=0.813) and FFR-guided treatment decision (4.1% vs. 3.6%; HR 1.14; 95% CI 0.56-2.32; P=0.715). In comparison of POCO in patients with deferred lesion, there was no significant difference between IVUS and FFR groups (6.2% vs. 5.9%; HR 1.05; 95% CI 0.61-1.80; P=0.856). Conclusion In patients with intermediate coronary artery stenosis, deferral of PCI based on IVUS-guided treatment decision showed comparable risk of clinical events with FFR-guided treatment decision.