An analysis of the FAME 2 trial shows an economically attractive and significant quality of life advantage for the intervention arm that used fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) to place one or more drug-eluting stents in patients with stable coronary disease.

The new findings were released on Oct. 24 at the TCT 2012 Meeting in Miami, Fl., several months after the trial was halted early due to an advantage in the experimental arm. Although FFR-guided PCI has higher initial cost than medical therapy, results showed the cost gap narrows >50 percent by one year. Further, full analysis of data from the shortened trial shows a significant advantage in quality of life as well as for the composite endpoint of death, myocardial infarction (MI) and urgent revascularization for the intervention arm. The study, which began in May 2010, was scheduled to run through Jan. 2017 but was halted in Jan. 2012.

The multicenter international randomized study was designed to compare the use of FFR-guided PCI with best medical therapy in patients with stable coronary disease. A total of 888 patients were enrolled in the trial — 447 in the PCI arm and 441 in the medical treatment arm. All had at least one documented stenosis with an FFR of 0.80 or less. An initial analysis of data collected showed that 4.3 percent of patients in the PCI arm died, had an MI or an urgent revascularization compared to 12.7 percent of patients in the medical treatment arm (p<0.001). There was no significant difference in rates of death (p=0.31) or MI (p=0.89), but urgent revascularization favored the PCI arm (<0.001), as published in The New England Journal of Medicine in Aug. 2012 and presented as a part of the ESC Congress 2012. The current analysis was designed to compare the economic and quality of life implications of the FFR–guided PCI strategy used in the FAME 2 trial.

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The direct medical costs of the index procedure and hospitalization were calculated from the actual resource consumption. All follow-up events were assigned costs based on the Medicare reimbursement rate for the appropriate diagnosis-related group. The cumulative costs over 12 months were calculated monthly using an incremental approach. Angina was assessed at baseline and again at one, six and 12 months. Quality of life was assessed using the EQ-5D with U.S. weights at baseline and one month. Because the trial was stopped early, only 11 percent of patients had 12-month quality-of-life data. The quality-of-life outcome was calculated by projecting one-month EQ-5D change scores.

The analysis showed that the mean one-year cost of FFR-guided PCI was $11,374 compared to $8,866 for medical therapy. The mean cumulative cost difference of $5,482 at baseline fell to $2,508 at 12 months based on increasing costs for follow-up care in the medical therapy group.

Quality of life at one month increased 0.054 for the PCI group and 0.003 for the medical therapy group (p<0.001). The combination of cost and quality of life changes yields a quality adjusted life year (QALY) cost of $53,000 for PCI based on in-trial results, and $32,000 based on three-year projections. These results compare with a cost of $50,000 per QALY for hemodialysis.

The analysis concluded that quality of life is significantly improved by FFR-guided PCI compared to medical therapy and that FFR-guided PCI is an economically attractive alternative to medical therapy.

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