Fractional flow reserve versus angiography in guiding management to optimize outcomes in non–ST-elevation myocardial infarction (FAMOUS-NSTEMI): Rationale and design of a randomized controlled clinical trial

Abstract

BackgroundIn patients with acute non–ST-elevation myocardial infarction (NSTEMI), coronary arteriography is usually recommended; but visual interpretation of the angiogram is subjective. We hypothesized that functional assessment of coronary stenosis severity with a pressure-sensitive guide wire (fractional flow reserve [FFR]) would have additive diagnostic, clinical, and health economic utility as compared with angiography-guided standard care.Methods and designA prospective multicenter parallel-group 1:1 randomized controlled superiority trial in 350 NSTEMI patients with ≥1 coronary stenosis ≥30% severity (threshold for FFR measurement) will be conducted. Patients will be randomized immediately after coronary angiography to the FFR-guided group or angiography-guided group. All patients will then undergo FFR measurement in all vessels with a coronary stenosis ≥30% severity including culprit and nonculprit lesions. Fractional flow reserve will be disclosed to guide treatment in the FFR-guided group but not disclosed in the “angiography-guided” group. In the FFR-guided group, an FFR ≤0.80 will be an indication for revascularization by percutaneous coronary intervention or coronary artery bypass surgery, as appropriate. The primary outcome is the between-group difference in the proportion of patients allocated to medical management only compared with revascularization. Secondary outcomes include the occurrence of cardiac death or hospitalization for myocardial infarction or heart failure, quality of life, and health care costs. The minimum and average follow-up periods for the primary analysis are 6 and 18 months, respectively.ConclusionsOur developmental clinical trial will address the feasibility of FFR measurement in NSTEMI and the influence of FFR disclosure on treatment decisions and health and economic outcomes.

Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?

“…Furthermore, this is a study of stable patients only and takes no account of the potential benefit of routine FFR in an ACS population, a question that is being addressed by the Fractional Flow Reserve Versus Angiography in Guiding Management to Optimise Outcomes in Non-ST-Segment-Elevation Myocardial Infarction (FAMOUS) study. 25 Therefore, we do not know from this study what effect FFR would have if used in this way in a consecutive all-comers group of patients. Third, several common patterns of CAD seen routinely at diagnostic angiography are poorly represented in this study population, including chronic total occlusions, left main stem lesions, and very diffusely diseased small vessels.…”

Fractional Flow Reserve: An Updated Review

“…Fractional flow reserve is of great benefit in these situations due to the lack of noninvasive imaging prior to coronary angiography, unlike stable CAD. An ongoing multicenter randomized trial, Fractional Flow Reserve Versus Angiography in Guiding Management to Optimize Outcomes in Non–ST‐Elevation Myocardial Infarction (FAMOUS‐NSTEMI) is evaluating the feasibility of FFR measurement in NSTEMI and the influence of FFR disclosure on treatment decisions and health and economic outcomes …”

Fractional flow reserve (FFR)-based therapy in patients presenting with acute coronary syndrome: Current data and everyday practice

“…No cases of adverse drug reactions related to the use of adenosine were recorded. The FAMOUS-NSTEMI [10,11] trial was created on the basis of the FAME trial [3], with the main differences seen in the type of patients who took part in the study (NSTEMI vs. CAD) as well as the degree of stenosis which was assessed (lesions ≥ 30% vs. ≥ 50%) [10,11]. A sub-study of FAMOUS-NSTEMI [10,11] compared FFR results with perfusion-magnetic resonance imaging (MRI) studies, and confirmed the diagnostic significance of FFR in stable patients with NSTEMI.…”

“…The FAMOUS-NSTEMI study compared angiographic assessment with FFR measurements with regards to determining further treatment in non-compromised patients with NSTEMI [10,11]. Patients were randomly assigned into one of three groups: coronary artery bypass graft (CABG), PCI or conservative treatment.…”

“…Some suggest that measurement of FFR is reliable in ACS, mainly in patients with non-ST-elevation myocardial infarction (NSTEMI) [10,11]; others show differences in FFR values in acute course when compared with FFR assessment after a few weeks or months [12]. Only a few randomized clinical trials (RCT) have been performed showing the efficacy of FFR-guided PCI in ACS.…”