6/28/23, 10:39 PM FLAVOUR Pathway Feedback Search Clinical Topics Home Studies FLAVOUR FLAVOUR Disease Coronary artery disease Trial question Is fractional flow reserve guidance noninferior to intravascular ultrasound guidance in patients with intermediate stenosis being evaluated for PCI? Study design Multi-center Open label RCT Population Characteristics of study participants 29.0% female N = 1682 71.0% male 1682 patients (495 female, 1187 male) Inclusion criteria: adult patients being evaluated for PCI for the treatment of intermediate stenosis Key exclusion criteria: noncardiac coexisting illness; life expectancy < 2 years; target lesion in the left main coronary artery or in a CABG; increased bleeding risk Interventions N=838 fractional flow reserve guidance (criterion for revascularization, fractional flow reserve 0.80) N=844 intravascular ultrasound guidance (criterion for revascularization, minimum lumen area 3 mm or minimum lumen area 4 mm and plaque burden > 70%) Primary outcome Composite outcome of death, myocardial infarction, or revascularization at 24 months https://web.pathway.md/studies/recg0XhuHwuREAQtQ 1/2 6/28/23, 10:39 PM FLAVOUR Pathway 8.5 % 8.5 8.1 6.4 % 4.3 % Difference not exceeding nonferiority margin 2.1 % 0.0 % Fractional flow reserve guidance Intravascular ultrasound guidance Difference not exceeding nonferiority margin in composite outcome of death, myocardial infarction, or revascularization at 24 months (8.1% vs. 8.5%; ARD -0.4, 95% CI -0.7 to -0.1) Secondary outcomes No significant difference in composite outcome of death, myocardial infarction, or revascularization at 12 months (4.6% vs. 3.4%; AD 1.1%, 95% CI -0.8 to 3) No significant difference in composite outcome of death from cardiac cause, target-vessel myocardial infarction, or target-lesion revascularization (3.3% vs. 3%; AD 0.3%, 95% CI -1.4 to 1.9) Significant decrease in the percentage of patients who had undergone PCI (44.4% vs. 65.3%; ARD -20.9, 95% CI -25.7 to -16.1) Conclusion In adult patients being evaluated for PCI for the treatment of intermediate stenosis, fractional flow reserve guidance was noninferior to intravascular ultrasound guidance with respect to the composite outcome of death, myocardial infarction, or revascularization at 24 months. Reference Bon-Kwon Koo, Xinyang Hu, Jeehoon Kang et al. Fractional Flow Reserve or Intravascular Ultrasonography to Guide PCI. N Engl J Med. 2022 Sep 1;387(9):779-789. Open reference URL https://web.pathway.md/studies/recg0XhuHwuREAQtQ 2/2