FAME 2 Compares FFR-Guided PCI to Medical Therapy in Patients With Stable CAD
November 2, 2017—New results from the Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 2 trial found that when compared with medical therapy (MT) alone, percutaneous coronary intervention (PCI) in patients with stable coronary artery disease (CAD) and abnormal fractional flow reserve (FFR) results in better clinical outcomes at similar cost over 3 years of follow-up. The findings were reported at TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 30 to November 2 in Denver, Colorado. The study was published simultaneously in Circulation.
FAME 2 is a prospective, international, randomized controlled trial conducted at 28 sites in Europe and North America. The study enrolled 1,220 patients with stable angina and angiographically documented one-, two-, or three-vessel CAD suitable for PCI with current-generation drug-eluting stents. Patients with stable angina and at least one coronary lesion with an abnormal FFR were randomized to either MT alone or PCI with MT.
As summarized in the TCT announcement, 888 of the 1,220 patients had at least one stenosis with an FFR ≤ 0.80 and were randomly assigned to PCI plus MT (n = 447 patients) or MT alone (n = 441 patients). Enrollment was stopped early based on advice from the data safety monitoring board because a significant difference had developed in the primary endpoint.
All analyses were by intent-to-treat; the primary endpoint was the rate of major adverse cardiac events (MACE), defined as a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization. Costs were calculated based on resource utilization and Medicare reimbursement rates. Changes in quality-adjusted life-years (QALYs) were assessed with utilities determined by the EuroQoL five dimensions health survey at baseline and over follow-up.
After 3 years, MACE occurred in 10.1% of patients randomized to PCI and in 22% of patients randomized to MT (P < .001). This was primarily driven by a reduction in the rate of urgent revascularization (4.3% vs 17.2%; P < .001), with nonsignificantly lower death or myocardial infarction in patients randomized to PCI (8.3% vs 10.4%; P = .28).
The rates of both urgent and nonurgent late revascularization were lower in the PCI group than the MT group, and the difference widened over time. After 3 years, 45 (10.3%) patients in the PCI group underwent a repeat revascularization compared with 195 (44.2%) patients in the MT group who underwent a late PCI. Angina was significantly less severe in the PCI group at all follow-up points to 3 years.
The initial procedure and hospitalization costs were significantly greater in the PCI group compared with the MT group ($9,944 ± 6,507 vs $4,440 ± 4,462; P < .001), mostly caused by the cost of the PCI procedure. Over the subsequent years, follow-up costs were higher in the MT group, and mean cumulative costs at 3 years were not significantly different between the PCI and MT groups ($16,792 ± 10,139 vs $16,737 ± 13,108; P = .94). The incremental cost-effectiveness ratio for PCI compared with MT was $17,300 per QALY at 2 years and $1,600 per QALY at 3 years.
In the TCT announcement, William F. Fearon, MD, commented, “Compared with MT alone, performing PCI in patients with stable coronary artery disease and at least one coronary lesion with an abnormal FFR leads to improved clinical outcomes, less angina, and improved quality of life at similar cost over 3 years of follow-up. With better clinical outcomes at similar cost, PCI of coronary lesions with reduced FFR is an economically attractive strategy.”