FAME 2: FFR-Guided PCI Cost Effective vs. Medical Therapy

MIAMI BEACH, FLA.—A strategy of FFR-guided PCI was shown to be cost effective in terms of quality-adjusted life years (QALY) when compared with medical therapy alone for patients with stable CAD. William F. Fearon, MD, of Stanford University, presented late-breaking results of a cost-effectiveness substudy of the FAME 2 trial at TCT 2012.

At 1 year, the cumulative cost of FFR-guided PCI was $2,508 more than medical therapy alone, but due to quality-of-life improvements observed with PCI the overall cost effectiveness of FFR-guided PCI was $53,000 per QALY. The 3-year projected cost for the FFR-guided PCI approach was $32,000 per QALY.

Initial per-patient costs were higher for FFR-guided PCI than medical therapy, but the cost gap narrowed by more than half at 1 year to $11,374 for FFR-guided intervention and $8,866 for medical therapy (see Figure).

FAME figureBaseline per-patient costs were higher for FFR-guided PCI primarily due to increasing costs of DES. During follow-up, costs were higher for the medical therapy arm primarily due to increased costs of follow-up revascularization, Fearon said.

Improvements in QOL

Data also showed QOL improvements with the FFR-guided strategy in FAME 2.

At 1 month, 89% of patients in the FFR-guided arm had class 0-1 angina vs. 71% in the medical therapy arm (P<.001) and 11% of patients who received FFR guidance had class 2-4 angina vs. 29% in the medical therapy arm (P<.001). This resulted in a significantly greater change in utility from baseline to 1 month with FFR-guided PCI of 0.054 compared with essentially no improvement, 0.003, in the medical therapy arm.

“FFR-guided PCI has a higher initial cost than medical therapy. However, the cost gap narrows more than 50% by 1 year,” Fearon said. “Since angina and QOL are significantly improved by PCI, results of this study indicate that FFR-guided PCI appears to be economically attractive.”

Study details

Previously published results from the overall FAME 2 trial showed that FFR-guided PCI improved the primary endpoint of death, MI or urgent revascularization when compared with medical therapy in 888 stable patients with single-, double- or triple-vessel CAD. The trial was stopped early after a mean follow-up of 7 months because of the significantly higher rate of the primary outcome in patients assigned medical therapy (4.3% vs. 12.7%; P<.001). This raised the question of whether benefits are worth the costs of up-front FFR-guided PCI in patients with stable CAD, Fearon said.

Of note, only 11% of patients had 12-month utility measured, due to the trial being stopped early. Fearon said the study is also limited by the short time horizon.

Disclosures
  • FAME 2 was sponsored by St. Jude Medical.
  • Dr. Fearon reports receiving grant/research support from St. Jude Medical, consultant fees/honoraria from Tryton Medical, and equity from Heartflow.

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