Table 2.
Landmark trials that established FFR as the most widely used invasive physiologic test.
Trial | DEFER [ 34 , 35 ] | FAME [ 32 ] | FAME 2 [ 33 ] |
---|---|---|---|
Design | RCT, multi-centric | RCT, multi-centric | RCT, multi-centric |
Number of patients | 325 | 1005 | 1220 |
Clinical syndrome | Stable CAD | Stable multi-vessel CAD | Stable CAD |
Primary endpoint | Absence of all-cause mortality, MI, CABG, PCI, and any procedure-related complication necessitating major intervention or prolonged hospital stay at 2 years | Death, nonfatal MI, and repeat revascularization at 1 year | Death from any cause, nonfatal MI, unplanned hospitalization leading to urgent revascularization during the first 2 years |
Key finding | Deferring PCI in lesions with FFR >0.75 is safe | FFR-guided PCI outperformed angiography guided PCI | FFR-guided PCI plus optimal medical therapy outperformed medical therapy alone |