MIAMI—While lead investigator William Fearon, MD, touted fractional flow reserve (FFR) as “economically attractive in this cost-effectiveness analysis,” a physician panel during the Oct. 24 presentation of FAME 2 Cost-Effectiveness questioned whether that can be determined since the trial was stopped early, and longer-term data are lacking. This results were presented as a late-breaking clinical trial at the Transcatheter Cardiovascular Therapeutics (TCT) conference.
The FAME 2 trial, a multicenter, international, randomized study, showed that FFR-guided PCI improved clinical outcomes when compared with optimal medical therapy in patients with stable coronary artery disease (CAD) (New Engl J Med 2012;367:991-1001).
The Data Safety Monitoring Board stopped the study short of its planned two-year endpoint, after an enrollment of 880 patients and a mean follow-up of seven months. In FAME 2, the primary endpoint of death, MI or urgent revascularization occurred in a significantly higher number of patients in the medical therapy arm, as compared with the FFR arm (12.7 vs. 4.3 percent).
These results “begged the question about whether the benefits of FFR are worth the costs of putting FFR-guidelines PCI with drug-eluting stents in all stable CAD patients,” Fearon said.
The cost difference at baseline of approximately $5,485 was significantly more expensive than medical therapy because of the higher costs of drug-eluting stents in the FFR arm. “That difference narrowed to $2,508 at one year,” Fearon said. “Based on the slope of the curves, it looks like it will continue to narrow with further time. The increased costs in the medical therapy arm were associated with increased revascularization.”
As a member of the physician panel, David P. Faxon, MD, of Brigham and Women’s Hospital in Boston, noted that the endpoints of FAME are not “hard endpoints,” because the improvement was just preventing a revascularization, and not death or MI.
With the quality-of-life improvements observed with PCI, the overall cost-effectiveness of upfront PCI was $53,000 per quality-adjusted life year (QALY). The three-year projected cost for the FFR-guided PCI approach was $32,000 per QALY.
“We want to be conservative, and not overstate things, but we believe these findings show FFR-guided PCI as a cost-effective strategy,” he said. “The in-trial results are lacking longer-term follow-up because the trial was stopped, but we think it’s realistic that the benefits of PCI last more than one year.”
“This FFR-guided strategy could be cost effective, but that is very much in the eyes of the interpreter,” noted Bernard J. Gersh, MD, of the Mayo Clinic in Rochester, Minn., on the physician panel.
To provide context for the findings, Fearon pointed out that $50,000 per QALY is the traditionally accepted cutoff based on hemodialysis. If a strategy falls below this, it can be considered cost effective. “However, the World Health Organization has proposed a different cutoff for the U.S. of $150,000 per QALY,” he said. “Using this threshold, one can conclude that any strategy falling above $150,000 per QALY is not likely to be accepted as cost effective, any strategy between $150,000 and $50,000 per QALY is likely to be considered cost effective and a strategy falling below $50,000 per QALY can be considered cost-effective.”
As a comparison, the COURAGE trial, which compared an angiographically guided PCI strategy to medical therapy, found that the cost-effective ratio was $168,000 per QALY, and therefore, not cost effective, explained Fearon.
“Now in FAME 2, we have shown that the cost-effectiveness ratio of an FFR-guided PCI strategy compared with medical therapy is favorable at $32,000 per QALY,” he said.
On the physician panel, Roxana Mehran, MD, of Mount Sinai Hospital in New York City, noted that “we would have loved to see the trial go on longer, even for more informed quality-of-life and cost-effectiveness data.”
St. Jude Medical sponsored the study.