Coronary disease & ACSRandomised controlled trial
Angiography-derived fractional flow reserve versus intravascular ultrasound to guide percutaneous coronary intervention in patients with coronary artery disease (FLAVOUR II): a multicentre, randomised, non-inferiority trial
- Randomised controlled trial
- investigator-initiated
- open-label
- multicentre
- non-inferiority
- 22 centres in China
Authors' conclusion
The angiography-derived FFR-guided comprehensive PCI strategy, encompassing revascularisation decision making and stent optimisation, was non-inferior to intravascular ultrasound guidance.
Study context
- Population
- Adults ≥18 years with suspected ischaemic heart disease and ≥50% stenosis in epicardial coronary arteries ≥2.5 mmenrolled
- Participants
- 1,872 adults
- Comparison
- Angiography-derived fractional flow reserve (FFR) vs intravascular ultrasound guidance of percutaneous coronary intervention (PCI)
- Angiography-derived FFRn = 923
- Intravascular ultrasoundn = 916reference
- Primary endpoint
- Composite of:
- Death
- MI
- Revascularisation (ITT population)
- Follow-up
- Median 12 months
Primary result
As reported in the abstract
Angiography-derived FFR vs Intravascular ultrasoundHazard ratio (95% one-sided CI)
Angiography-derived FFR
1.04(0.71–1.51)
Non-inferiority margin 2.5 as printed, not drawn
- upper boundary of one-sided 97.5% CI
- absolute difference 0.2 percentage points (one-sided 97.5% CI 2.4); P for non-inferiority = 0.022
Further findings
| Outcome | Angiography-derived FFR | Intravascular ultrasound | absolute difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| Mortality | 1.8% | 1.3% | 0.4 (−0.7 to 1.6) | ||
| −1012Difference, percentage points (linear scale) |
| Outcome | HR (CI) | P value | |
|---|---|---|---|
| Mortality | 1.34 (0.63–2.83) | P = 0.45 | |
| 0.20.5125Hazard ratio (log scale) |
Recurrent angina
Target vessels revascularised
- Target vessels revascularised: of 990 vs 984 target vessels
Original publication
Angiography-derived fractional flow reserve versus intravascular ultrasound to guide percutaneous coronary intervention in patients with coronary artery disease (FLAVOUR II): a multicentre, randomised, non-inferiority trial. Lancet. Published 30 March 2025. doi:10.1016/s0140-6736(25)00504-5
Summarised from the published abstract; every number is checked against it