- Question
- In patients with intermediate coronary stenosis being evaluated for PCI, is a fractional flow reserve (FFR)-guided strategy noninferior to an intravascular ultrasonography (IVUS)-guided strategy in terms of clinical outcomes?
- Design
- Randomized 1:1, open-label (no masking) noninferiority trial enrolling 1682 patients. The noninferiority margin was 2.5 percentage points and follow-up was 24 months.
- Population
- Patients being evaluated for percutaneous coronary intervention for intermediate stenosis (40 to 70% occlusion by visual estimation on coronary angiography).
- Intervention
- FFR-guided PCI, with FFR used both to decide on revascularization and to assess the procedural result; PCI was performed if FFR was 0.80 or less.
- Control
- IVUS-guided PCI; PCI was performed if the minimal lumen area was 3 mm2 or less, or 3 to 4 mm2 with a plaque burden above 70%.
- Primary outcome
- Composite of death, myocardial infarction, or revascularization at 24 months after randomization.
- Results
- PCI was performed in 44.4% of the FFR group and 65.3% of the IVUS group. The primary outcome occurred in 8.1% with FFR and 8.5% with IVUS (absolute difference -0.4 percentage points; upper boundary of the one-sided 97.5% CI 2.2 percentage points; P = 0.01 for noninferiority). Patient-reported outcomes on the Seattle Angina Questionnaire were similar between groups.
- Conclusion
- In intermediate stenosis, FFR guidance was noninferior to IVUS guidance for the composite of death, myocardial infarction, or revascularization at 24 months.
- Why it matters
- The trial showed that either tool can guide the decision to revascularize and the PCI itself in intermediate stenoses with comparable clinical outcomes, although the FFR strategy involved fewer PCI procedures.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026