Fractional Flow Reserve–Guided PCI Versus Medical Therapy in Stable Coronary Disease (FAME 2)

Not every coronary narrowing actually starves the heart muscle of blood. FAME 2 tested a smarter way to decide which blockages to stent: measure whether a narrowing is functionally significant using fractional flow reserve (FFR), then treat only those that are.

Among patients with stable disease and FFR-confirmed flow-limiting stenoses, PCI plus medical therapy sharply reduced the need for urgent revascularization compared with medical therapy alone (hazard ratio 0.32). The benefit, however, was driven by that urgent-revascularization endpoint — a softer outcome — rather than by reductions in death or heart attack, which did not differ significantly.

The trial sits in productive tension with COURAGE and ISCHEMIA, which found stenting did not reduce hard events in stable disease. FAME 2’s contribution is the principle of physiology-guided selection: if you are going to intervene, FFR helps target the lesions that matter — though it did not overturn the broader finding that stenting stable disease does not save lives.

We rate the evidence strong. It is a well-conducted randomized trial that advanced FFR-guided decision-making, with the important caveat that its headline benefit rests on a less-hard endpoint.