Careful and stepwise evaluation of the fractional flow reserve (FFR) index has been performed over the years, culminating in the landmark Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease (FAME II) trials. Findings from these studies demonstrated unequivocally the overall inadequacy of angiography versus FFR to correctly assess stenosis severity. Thus, proof of concept and clinical applicability was established beyond debate and will be discussed here.
KeywordsCoronary artery disease, ischaemia, angiography, fractional flow reserve, FAME Disclosure: The authors have no disclosures to make that are relevant to the present article. The presence as well as the extent of myocardial ischaemia are key to determining cardiovascular outcome, 1-3 thus its identification is important. An endeavour to improve diagnostic accuracy in deciding which angiographic lesions are haemodynamically significant led to the development of the concept of fractional flow reserve (FFR). Based on pressure-flow analysis of a stenosis during maximum flow, the FFR indicates the impact of a coronary stenosis on the maximum inducible coronary flow and whether it would be susceptible to induce ischaemia during stress. In a landmark report, Pijls and co-workers validated the FFR index in a group of patients with single moderate coronary artery stenosis using three different non-invasive stress tests (exercise test, thallium scan and stress echocardiogram). 4 Based on the findings of this study, the authors proposed a cut-off FFR value of 0.75 as a threshold for discrimination between ischaemia-inducible and ischaemia-noninducible lesions (see for example Figure 1).
In the DEFER (Deferral versus Performance of PercutaneousTransluminal Coronary Angioplasty in Patients Without Documented Ischaemia) trial, the predictive value of this novel invasive index was tested for the first time in patients. 5 The DEFER study was designed to investigate the safety and outcomes of deferring stenting in angiographic (FFR >0.75) stenoses. A total of 325 patients who were referred for percutaneous coronary intervention (PCI) due to an angiographic significant stenosis of >50 % were randomised to either the PCI group or PCI-deferral group. PCI was performed regardless of the FFR value in the PCI group. In the PCI-deferral group, PCI was undertaken only when the FFR was ≤0.75, and was deferred when the FFR was >0.75. At 12 months, event-free survival rates were similar in the deferral and PCI groups (89 versus 83 %, respectively; p=0.27).The results of this study indicate that a large number of patients referred for PCI on the basis of a coronary stenosis without objective proof of ischaemia had nonsignificant lesions as indicated by the FFR value. Stenting these patients did not reduce the rates of adverse cardiac events neither did it result in an...