Following ORBITA, which indicated percutaneous coronary intervention (PCI) did not provide benefit over a sham procedure in patients with stable coronary artery disease, the three-year results of the FAME-2 trial indicate that fractional flow reserve (FFR)-guided PCI improves clinical outcomes compared with medical management alone.
The ORBITA (Objective randomised blinded investigation with optimal medical therapy of angioplasty in stable disease) caused controversy at the 2017 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–1 November) when it indicated that there was no advantages with PCI for stable coronary artery disease compared with a sham procedure. However, a criticism of the study was that some of the patients in the PCI may not have had severe enough lesions to warrant them undergoing angioplasty; thus, potentially skewing the results. Furthermore, some have suggested that rather than showing PCI is not beneficial for stable disease, ORBITA shows that angioplasty should not be used to guide PCI and physiological assessment should be used instead.
FAME (Fractional flow reserve versus angioplasty for multivessel evaluation) 2, which was presented at TCT directly after ORBITA, has, therefore, been seen as supportive evidence of the value of physiological assessment-guided PCI for stable coronary artery disease. It has already indicated that FFR-guided PCI reduces the risk of the composite rate of death, myocardial infarction, or urgent revascularisation compared with optimal medical therapy at two years in patients with stable disease.
Simultaneous to its presentation at TCT, FAME-2 was published in Circulation. In that journal, William F Fearon (Division of Cardiovascular Medicine, Stanford University School of Medicine and Stanford Cardiovascular Institute, Stanford, USA)—who presented the study at TCT—and others report that the aim of the new analysis was to review the three-year outcomes of the study. In the study, patients with a ≥1 stenosis in a major coronary artery with a FFR of ≤80 were randomised to undergo PCI or to receive optimal medical therapy. The primary endpoint was the aforementioned composite of death, myocardial infarction, or urgent revascularisation.
Of the patients randomised (888), 447 were assigned to FFR-guided PCI plus medical therapy and 441 were assigned to medical therapy alone. At three years, the rate major adverse cardiac events (MACE) were significantly reduced in the PCI group: 10.1% vs. 22% (p<0.001). Fearon et al comment: “There was a non-significant reduction in death or myocardial infarction in patients randomised to PCI (8.3% vs. 10.4% for medical therapy; p=0.28) and a highly significant difference in the rate of urgent revascularisation (4.3% vs. 17.2%; p<0.001).” They add that the percentage of patients with angina Canadian Cardiovascular Society (CCS) grade II, III, or IV was also significantly lower in the PCI group.
While the initial procedure and hospitalisation costs were significantly higher with PCI, over the subsequent years, follow-up costs were higher in the medical therapy group. “Such that the mean cumulative costs at three years were not significantly different between the PCI group and the medical therapy group (US$16,792±US$10,139 vs. US£16,737±US$13,108;p=0.94),” the authors observe. They also note that, at three years, the incremental cost-effectiveness ratio for PCI—compared with medical therapy was US$1,600 per quality-adjusted life year (QALY) and “was below a willingness-to-pay threshold of US$50,000 per QALY in 85% of 10,000 bootstrap replications”.
Fearon told Cardiovascular News: “The three year results of the FAME 2 study demonstrate that FFR-guided stenting significantly improves the quality of life of patients with stable coronary disease at no additional cost when compared with medical therapy alone.”