FAMOUS-NSTEMI - FAMOUS-NSTEMI
The goal of the trial was to evaluate a fractional flow reserve (FFR)-guided strategy compared with a coronary angiography-guided strategy among participants with non–ST-segment elevation myocardial infarction (NSTEMI).
An FFR-guided strategy will increase the proportion of patients managed medically.
- Participants with NSTEMI and planned invasive therapy within 72 hours or recurrent ischemic symptoms within 5 days
- At least one coronary stenosis ≥30% for which FFR could have diagnostic value
Number of enrollees: 350
Duration of follow-up: 6 and 12 months
Mean patient age: 62 years
Percentage female: 26%
- Refractory angina
- Hemodynamic instability
- Intolerance to antiplatelet drugs
- Ineligible for coronary revascularization
- Planned valve surgery
- History of coronary artery bypass grafting
- Severe coronary artery disease (CAD) (i.e., diffuse calcification) or nonobstructive CAD (i.e., <30% stenosis)
- Limited life expectancy
- Proportion of patients allocated to medical management
- Safety of routine FFR measurement
Participants with NSTEMI were randomized to an FFR-guided strategy (n = 176) versus a coronary angiography-guided strategy (n = 174).
All coronary stenoses ≥30% underwent FFR. The FFR value was disclosed to the operator in the FFR-guided group, and revascularization was recommended for FFR ≤0.8. The FFR value was not disclosed to the operator in the angiography-guided group, and revascularization was according to operator discretion.
- Aspirin: 99%
- P2Y12 inhibitor: 100%
- Statin: 95.5%
- Beta-blocker: 91.5%
Overall, 350 patients were randomized. The mean age was 62 years, 26% were women, 41% were current smokers, 13% had a prior MI, and 15% had diabetes.
FFR was measured in 704 lesions, of which 61.1% were hemodynamically significant. Two dissections were attributable to the FFR wire. FFR resulted in a change in treatment plan in 22% of participants.
The proportion of patients treated medically was 22.7% in the FFR group vs. 13.2% of the angiography group (p = 0.022).
- Major adverse cardiac events (MACE) at 12 months: 8.0% vs. 8.6% (p = 0.89), respectively
- MACE, excluding periprocedural MI at 12 months: 5.7% vs. 2.9% (p = 0.25), respectively
- Periprocedural MI: 2.8% vs. 6.3% (p = 0.12), respectively
- Spontaneous MI: 4.0% vs. 2.9% (p = 0.69), respectively
- Freedom from revascularization at 12 months: 21.0% vs. 13.2% (p = 0.054), respectively
Among patients with NSTEMI, an FFR-guided strategy was feasible. An FFR-guided strategy changed the initial treatment plan in approximately one-fifth of cases and resulted in a larger proportion of patients treated medically compared with an angiography-guided strategy. MACE were similar between treatment groups, although periprocedural MI tended to be higher in the angiography-guided group, and spontaneous MI tended to be higher in the FFR-guided group.
Layland J, Oldroyd KG, Curzen N, et al. Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS–NSTEMI randomized trial. Eur Heart J 2014;Sep 1:[Epub ahead of print].
Presented by Dr. Colin Berry at the European Society of Cardiology Congress, Barcelona, Spain, September 1, 2014.
Keywords: Myocardial Infarction, Coronary Stenosis, Coronary Angiography, Hemodynamics, Diabetes Mellitus, ESC Congress
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