- Question
- In patients with stable coronary artery disease and functionally significant stenoses by fractional flow reserve (FFR), is FFR-guided PCI plus best available medical therapy superior to medical therapy alone?
- Design
- Randomized trial, unblinded per the registry, in which all stenoses were assessed by FFR in patients being considered for PCI. A total of 1220 patients were enrolled: 888 were randomized and 332 entered a registry. Recruitment was halted prematurely because of a significant between-group difference.
- Population
- Patients with stable coronary artery disease being considered for PCI who had at least one functionally significant stenosis (FFR ≤ 0.80). Those with all stenoses at FFR > 0.80 were not randomized and were entered into a registry.
- Intervention
- FFR-guided PCI plus the best available medical therapy.
- Control
- Best available medical therapy alone.
- Primary outcome
- Composite of death, myocardial infarction, or urgent revascularization.
- Results
- The primary end-point event occurred in 4.3% of the PCI group and 12.7% of the medical-therapy group (HR with PCI 0.32; 95% CI 0.19 to 0.53; P<0.001). The difference was driven by fewer urgent revascularizations with PCI (1.6% vs. 11.1%; HR 0.13; 95% CI 0.06 to 0.30; P<0.001). In the registry, 3.0% had a primary end-point event.
- Conclusion
- In stable coronary artery disease with functionally significant stenoses, FFR-guided PCI plus medical therapy reduced the need for urgent revascularization compared with medical therapy alone, and in patients without ischemia the outcome with medical therapy alone appeared favorable.
- Why it matters
- It strengthened the role of invasive functional assessment in deciding which stable patients benefit from revascularization, and supported medical therapy alone when no functionally significant stenosis is present.
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 10, 2026