Fractional flow reserve (FFR)-guided PCI in patients with multivessel coronary disease is one of those rare situations in which a new technology not only improves outcomes but also saves resources, according to an economic evaluation of the FAME study published in the Dec. 14 issue of Circulation.
The FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study demonstrated significantly improved health outcomes at one year in patients randomized to multivessel PCI guided by FFR, compared with PCI guided by angiography alone. Prior to this study, the economic impact of routine measurement of FFR in this setting was not known.
“The trial design was a one-year analysis from the U.S. healthcare perspective,” William F. Fearon, MD, from the division of cardiovascular medicine at Stanford University Medical Center in Stanford, Calif., told Cardiovascular Business News. “Anytime a new medical technique or technology emerges, it must show that it has the capability of improving patient outcomes. However, given the current economic and healthcare environment, it also is beneficial to show its cost-effectiveness.”
In this study, 1,005 patients were randomly assigned to FFR-guided or angiography-guided PCI and followed up for one year. A prospective cost-utility analysis comparing costs and quality-adjusted life-years (QALYs) was performed with a time horizon of one year. Direct medical costs included those of the index procedure and hospitalization and costs for major adverse cardiac events during follow-up.
They found that the major adverse cardiac events at one year occurred in 13.2 percent of those in the FFR-guided arm and 18.3 percent of those in the angiography-guided arm. QALYs were slightly greater in the FFR-guided arm (0.853 vs. 0.838).
From an economic perspective, they found that the mean overall costs at one year were significantly less in the FFR-guided arm ($14,315 vs. $16,700). Bootstrap simulation indicated that the FFR-guided strategy was cost saving in 90.74 percent and cost effective at a threshold of $50,000 per QALYs in 99.96 percent.
The authors wrote that the “cost savings occur both at the index procedure, primarily owing to a decrease in drug-eluting stent use being a major cost driver, which more than offsets the increased cost of the pressure wire and adenosine, and during follow-up as a result of a decrease in re-hospitalization and fewer major adverse cardiac events.”
Fearon noted that procedural costs accounted for approximately 70 percent of the cost savings, and the follow-up event rates accounted for about 30 percent of the savings.
Overall, the researchers reported that about 90 percent of the total cost occurred at the index hospitalization. However, approximately 30 percent of the overall cost difference between the two strategies is generated during follow-up, indicating increasing cost savings even after the initial procedure.
While the authors mentioned, as a limitation, that the "durability of these findings need to be confirmed after longer follow-up," Fearon hypothesized that the longer-term findings, such as out of five years, may not prove "drastically different," as most of the events and costs occurred during the PCI procedure or soon after the PCI procedure for the FAME patients.
“We were pleased to find out that FFR-guided PCI is not only cost effective, but it also saves money for the U.S. healthcare system,” Fearon said.