Fractional flow reserve–guided PCI reduced urgent revascularization at 7 months in coronary artery disease

Randomized controlled trial (Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2 [FAME 2] study). ClinicalTrials.gov NCT01132495.

Concealed.*

Blinded* (outcome assessors, {data analysts, and data safety and monitoring committee}†).

Mean 213 days. Study was stopped early for apparent benefit.

28 sites in Europe and North America.

888 patients ≥ 21 years of age (mean age 64 y, 78% men) in stable condition who had 1-, 2-, or 3-vessel coronary artery disease suitable for PCI at coronary angiography and ≥ 1 stenosis in a major coronary artery with FFR ≤ 0.80. Exclusion criteria included need for revascularization, ≤ 1 week since ST-segment elevation MI (STEMI) or non-STEMI, prior or preferred treatment with coronary artery bypass graft, or left ventricular ejection fraction < 30%.

FFR-guided PCI plus MT (n = 447) or MT alone (n = 441). MT comprised aspirin, metoprolol (or other β₁-selective blocker, alone or with a calcium-channel blocker or long-acting nitrate), lisinopril (or other angiotensin-converting enzyme inhibitor or angiotensin II–receptor blocker), and a statin for low-density lipoprotein target < 70 mg/dL. PCI plus MT patients received clopidogrel, 75 mg/d, for ≥ 12 months.

Primary end point was a composite of all-cause death, nonfatal MI, or urgent revascularization (during unplanned hospitalization for persistent or increasing chest pain, with or without ST-segment or T-wave changes or elevated biomarker levels) at 2 years. Secondary outcomes included components of the primary outcome.

99.7% (intention-to-treat analysis).