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
Key result
The FAMOUS-NSTEMI trial will evaluate whether FFR-guided management alters the proportion of NSTEMI patients allocated to medical management versus revascularization compared to angiography.
Why the study?
Does FFR-guided management alter the proportion of patients allocated to medical management compared to angiography-guided care in NSTEMI patients?
Population
350 NSTEMI patients with ≥1 coronary stenosis ≥30% severity
Comparison
Fractional flow reserve-guided management, where… vs Angiography-guided standard care, where FFR is…
Design
RCT, 1:1 randomized, FFR disclosed in the FFR-guided group but not disclosed…
Follow-up
minimum 6 months, average 18 months
Authors
Discussion
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Member takes
Implication
Will clarify if FFR shifts NSTEMI patients toward medical management; extends FFR evidence from stable CAD to acute settings.
Study Design
Type
RCT (n=350)
Randomization
1:1
Multicenter
Yes
Structured PICO
Does FFR-guided management alter the proportion of patients allocated to medical management compared to angiography-guided care in NSTEMI patients?
P
Population
350 patients with acute NSTEMI and ≥1 coronary stenosis ≥30% severity, followed for an average of 18 months.
I
Intervention
Fractional flow reserve (FFR)-guided management, where FFR is disclosed to guide treatment and FFR ≤0.80 is an indication for revascularization
C
Comparator
Angiography-guided standard care, where FFR is measured but not disclosed to guide treatment
O
Outcome
Between-group difference in the proportion of patients allocated to medical management only compared with revascularization
The FAMOUS-NSTEMI trial is designed to evaluate whether routine FFR measurement in NSTEMI patients alters the proportion of patients managed medically versus with revascularization.
Cite This Study
Berry et al. (2013) conducted an RCT in acute non-ST-elevation myocardial infarction (NSTEMI) (n=350). Fractional flow reserve (FFR)-guided management vs. Angiography-guided standard care was evaluated on between-group difference in the proportion of patients allocated to medical management only compared with revascularization. The FAMOUS-NSTEMI trial will evaluate whether FFR-guided management alters the proportion of NSTEMI patients allocated to medical management versus revascularization compared to angiography.