FAST III: Angiography-Based Physiology vs Pressure-Wire Guidance

Key Takeaways

• vFFR-guided and FFR-guided strategies had the same reported 1-year primary-endpoint rate, and the authors concluded noninferiority.
• FAST III was an international, open-label, randomized noninferiority trial at 37 European sites in patients with intermediate coronary-artery lesions and chronic or acute coronary syndromes.
• Serious adverse events were similar in the two groups.

In FAST III, 1-year primary-endpoint rates were 7.5% in both groups when angiography-derived vFFR was compared with pressure-wire FFR for intermediate coronary lesions. The randomized comparison enrolled patients with chronic or acute coronary syndromes and evaluated two physiologic strategies for guiding revascularization.

FAST III was an international, open-label, randomized noninferiority trial conducted at 37 European sites. Patients had intermediate coronary-artery lesions with 30% to 80% diameter stenosis and chronic or acute coronary syndromes. Participants were randomized 1:1 to vFFR-guided or pressure-wire FFR-guided revascularization, and vFFR was derived from three-dimensional quantitative coronary angiography without a pressure wire or hyperemic agent. The primary endpoint was assessed in 1116 patients in the vFFR group and 1095 in the FFR group, with a mean age of 67 years, 24.3% women, 18.7% acute coronary syndrome, and 26.6% diabetes mellitus.

The prespecified primary endpoint was a 1-year composite of death from any cause, any myocardial infarction, or any revascularization. The noninferiority margin was 3.0 percentage points, defining the main statistical framework before results were assessed. At 1 year, 80 patients in the vFFR group and 79 in the FFR group had a primary-endpoint event, for a risk difference of -0.02 percentage points. The 95% confidence interval ranged from -2.25 to 2.21, and P=0.004 for noninferiority.

Serious adverse events were similar in the two groups.