At the 2012 Transcatheter Cardiovascular Therapeutics (TCT; 22–26 October, Miami, USA) meeting, reporting on the results of an economic analysis of the FAME II study, William Fearon, Division of Cardiovascular Medicine, Stanford University Medical Center, Stanford, USA, said that fractional flow reserve (FFR) guided percutaneous coronary intervention (PCI) was cost-effective, compared with medical management, in patients with stable coronary disease (CAD).
Fearon explained that the FAME II study was a multicentre, international, randomised study that compared FFR-guided PCI with medical management in patients with stable CAD and said that all target lesions were measured with FFR prior to randomisation. Patients whose lesions were not thought to be haemodynamically significant and were unlikely to be responsible for symptoms or future events were not included in the study and instead formed a registry.
However, patients who, as indicated by FFR, had significant ischaemia were randomised to receive FFR-guided PCI or medical management. The trial was stopped early, after about only seven months of follow-up, because of a significantly higher rate of the composite endpoint of death, myocardial infarction, and urgent revascularisation in patients assigned to the medical therapy arm. Fearon said: “There was no difference in death or myocardial infarction between the two groups, but there was a significantly greater rate of urgent revascularisation in the medical arm. In addition, freedom from angina was significantly greater, after one month, in patients assigned to the FFR-guided PCI arm. This raises the question of whether the key benefits of FFR-guided PCI are worth the upfront costs of this intervention. Therefore, the aim of this presentation is to describe the economic and quality of life implications of FFR-guided PCI vs. medical management.”
Direct medical costs of the index procedure and hospitalisation were calculated from the actual resource consumption, the costs of follow-up events were based on Medicare’s reimbursement rate per diagnosis related group, and the cumulative costs were assessed monthly using an incremental approach. Quality of life was assessed using EQ-5D with USA weights at baseline, at one month and at 12 months. Fearon commented: “We calculated the cost-effectiveness ratio during the first 12 months (in-trial) and, because the treatment effect is likely to extend further, we projected this analysis to three years.” He added that the cost-effectiveness ratio was calculated by dividing the cost of FFR-guided PCI therapy minus the cost of medical therapy by the change in quality of life observed in the FFR-guided PCI group minus the change in quality of life observed in the medical management group.
According to the results, at baseline, the cost of FFR-guided PCI was significantly higher than the cost of medical management—US$8.790 vs. US$3,305 respectively. However, this initial cost difference of US$5,500 narrowed to a cost difference of US$2,500 over one year. The change in quality of life was greater in the FFR-guided PCI arm than in the medical management arm: 0.054 vs. 0.003 [no real change]; p<0.001. Fearon reported: “After one year, the cost-effectiveness ratio of FFR-guided PCI is US$53,000 per quality adjusted life year (QALY). We also did a three-year projection, assuming the cost difference between FFR-guided PCI and medical management would not change and that the quality of life difference present at one month would decline linearly and no longer be present after three years. Using this more realistic scenario, the cost-effectiveness of FFR-guided PCI was US$32,000 per QALY.” He added that, “to provide context, the World Health Organization has recently proposed a new standard of cost-effectiveness in which cost per QALY should be three times that of the gross domestic product (GDP), which would be about US$150,000 per QALY in the USA. Fearon said: “If a strategy falls above this point, it is not economically attractive. If strategy falls between US$50,000 [the traditional standard] and US$150,000, it may or may not be cost-effective.” He added that in the COURAGE study, angio-guided PCI had a cost-effectiveness ratio of US$168,000 and in the FAME I study, FFR-guided PCI was found to cost less than angio-guided PCI and improve outcomes. Concluding his presentation, Fearon said: “FFR-guided PCI has higher initial costs than medical therapy but this cost gaps narrows by more than US50% at one year. Angina and quality of life are significantly improved by FFR-guided PCI compared with medical therapy. FFR-guided PCI appears to be economically attractive in a cost-effective analysis.”
Discussion at TCT
In the discussion section after Fearon presented the results, the session moderator Martin B Leon, Columbia University Medical Center, New York-Presbyterian Hospital, New York, USA, asked Fearon about the criticism levelled at the FAME II study that urgent revascularisation was a subjective endpoint. Fearon replied: “We should view urgent revascularisation as a failure of our therapy…when you look at the urgent revascularisation in the study, half of it was driven by objective measures—biomarkers or ECG changes. If you look just at this proportion of patients, there were still a highly significant greater number of patients in the medical arm than in the FFR-guided PCI arm undergoing urgent revascularisation. Therefore, I think urgent revascularisation is a valid endpoint.”
Cindy Grines, Detroit Medical Center, Detroit, USA, who was on the discussion panel, said: “We underestimate the importance of quality of life, so I think it is a big asset of this trial that it shows an improvement in quality of life. We never thought with stable CAD that we were going to reduce mortality or reduce the risk of reinfarction but what we are going to be doing [with FFR-guided PCI] is improving quality of life. Quality of life is a very important endpoint.”