Fractional flow reserve-guided percutaneous coronary intervention versus medical therapy for stable coronary artery disease: long-term results of the FAME 2 trial.

Summary

In stable CAD with FFR ≤0.80 lesions, FFR-guided PCI demonstrated a durable reduction in the composite of death, MI, or urgent revascularization over a median 11.2 years, driven primarily by fewer urgent revascularizations. Mortality was similar, with a non-significant trend toward fewer MIs.

Key Findings

• Median 11.2-year follow-up showed a win ratio of 1.25 favoring FFR-guided PCI for the composite endpoint.
• Large reduction in urgent revascularizations (win ratio 4.57) drove the composite benefit.
• All-cause mortality was similar (win ratio 0.88), and MI reduction trended in favor of PCI (win ratio 1.50, CI crossing 1).

Clinical Implications

For patients with FFR-positive lesions, revascularization guided by FFR offers sustained reduction in urgent revascularizations and composite events; shared decision-making should emphasize symptomatic status, ischemic burden, and patient values given neutral mortality.

Limitations

• Composite benefit primarily driven by urgent revascularization rather than mortality
• Open-label nature and potential treatment crossover over long follow-up

Future Directions

Refine patient selection using physiology and imaging to identify subgroups with MI or mortality benefit; assess cost-effectiveness and quality-of-life over decades.