Long-Term Outcomes After Fractional Flow Reserve vs Intravascular Ultrasound to Guide PCI: The FLAVOUR Trial Extended Follow-Up

Yang, S; Hu, X; Zhang, J; Jiang, J; Hahn, JY; Doh, JH; Lee, BK; Kim, W; Huang, J; Jiang, F; Zhou, H; Chen, P; Tang, L; Jiang, W; Chen, H; Chen, X; He, W; Ahn, SG; Tahk, SJ; Kim, U; Hwang, D; Kang, J; Ki, YJ; Shin, ES; Nam, CW; Wang, J; Koo, BK; FLAVOUR Investigators

doi:10.1016/j.jacc.2025.06.042

Coronary disease & ACS

Long-Term Outcomes After Fractional Flow Reserve vs Intravascular Ultrasound to Guide Percutaneous Coronary Intervention (PCI): The FLAVOUR Trial Extended Follow-Up

J Am Coll CardiolPublished 26 Aug 2025Randomised controlled trial

Primary resultResultHazard ratio 1.15 95% CI 0.93–1.42

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Authors' conclusion

FFR-guided and IVUS-guided treatment strategies resulted in comparable long-term outcomes, with no significant difference in patient-oriented composite outcomes.

Study context

Population: Patients aged ≥19 years with de novo intermediate coronary stenosis (40%-70%) and target vessel diameters ≥2.5 mm
Participants: 1,682 patients

Comparison: Fractional flow reserve (FFR)-guided vs intravascular ultrasound (IVUS)-guided treatment
FFRn = 838
IVUSn = 844reference
Primary endpoint: Composite of:
All-cause death
MI
Any revascularization after the index procedure
Follow-up: Median 6.3 years (Q1-Q3: 5.6-6.9 years)

Methodological detailsopen-label, multinational, 18 sites in Korea and China, extended follow-up

Open-label
Multinational
18 sites in Korea and China
Extended follow-up

Primary result

As reported in the abstract

median 6.3 years

Hazard ratio

1.15

95% CI 0.93–1.42

P = 0.208

Events by treatment group

FFR23.1%179

IVUS20.9%160

FFR vs IVUS

HR 1.15 (95% CI 0.93–1.42); P = 0.208

Secondary outcomes

Outcome	FFR	IVUS	← Lower risk with FFR ←→ Higher risk with FFR →	HR (95% CI)	P value
Revascularization after index procedure	14.9%	11.8%	0.512	1.32 (1.00–1.75)	P = 0.049
Target vessel revascularization	9.6%	6.2%	0.512	1.67 (1.15–2.43)	P = 0.007
			0.512Hazard ratio (log scale)

Overall target vessel PCI (index and follow-up)

P < 0.001

FFR38.8%

IVUS60.5%

Revascularization after index procedure: driven primarily by late (2-7 years) revascularizations in vessels with initially deferred PCI

Death or MI

No statistically significant differences in annual cumulative incidence of death or MI between groups

Original publication

Long-Term Outcomes After Fractional Flow Reserve vs Intravascular Ultrasound to Guide PCI: The FLAVOUR Trial Extended Follow-Up. J Am Coll Cardiol. Published 26 August 2025. doi:10.1016/j.jacc.2025.06.042

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Summarised from the published abstract; every number is checked against it