FLAVOUR
Trial question
Is FFR 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
71.0% male
N = 1682
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 FFR guidance (criterion for revascularization, FFR ≤ 0.80).
N=844 intravascular ultrasound guidance (criterion for revascularization, minimum lumen area ≤ 3 mm² or minimum lumen area ≤ 4 mm² and plaque burden > 70%).
Primary outcome
Composite outcome of death, MI, or revascularization at 24 months
8.1%
8.5%
8.5 %
6.4 %
4.3 %
2.1 %
0.0 %
Fractional flow reserve
guidance
Intravascular ultrasound
guidance
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in composite outcome of death, MI, 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, MI, 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 MI, or target-lesion revascularization (3.3% vs. 3%; AD 0.3%, 95% CI -1.4 to 1.9).
Significant decrease in 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, FFR guidance was noninferior to intravascular ultrasound guidance with respect to the composite outcome of death, MI, 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.
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