Is FAME 2 a breakthrough for PCI in stable coronary disease?

In the Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2 (FAME 2) study, 888 patients with stable coronary artery disease were randomised either to fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) plus optimal medical therapy or optimal medical therapy alone [1]. Before randomization, FFR was measured in all angiographically visible stenoses and patients who had at least one stenosis in a major coronary artery with a FFR of 0.80 or less were randomised. Patients who did not fulfil criteria were followed in a separate registry. This inclusion algorithm resulted in an optimal selection of patients for PCI as judged by current standards. Recruitment was halted prematurely because of a significant between-group difference in the percentage of patients who had a primary endpoint event. The primary endpoint was a composite of death, myocardial infarction (MI) or urgent revascularization. The difference in primary endpoint events at 1 year into the study (12.7 % in the medical-therapy group vs. 4.3 % in the PCI group) was driven by a higher number of urgent revascularizations in the medical-therapy group (11.1 vs. 1.6 %). There was also a trend towards fewer hard events (death or myocardial infarction) in the PCI group (3.4 vs. 3.9 % or 15 vs. 17 events, respectively) [1]. In a so-called “landmark” analysis from 8 days to 1 year (which excluded the excess number of peri-interventional endpoints in the PCI group occurring between days 1 and 7), this small difference was transformed into a hazard ratio of 0.42 in favour of PCI with a p value of 0.053.