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
Why the study?
Does fractional flow reserve (FFR)-guided management increase the proportion of patients treated initially by medical therapy compared to angiography-guided standard care in NSTEMI patients?
Population
350 NSTEMI patients with ≥1 coronary stenosis ≥30% of the lumen diameter assessed visually, enrolled in six…
Comparison
Fractional flow reserve-guided management, where… vs Angiography-guided standard care, where FFR was…
Design
RCT, 1:1 randomized, parallel group, FFR disclosed to operator in FFR-guided…
Follow-up
12 months
Authors
Discussion
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Implication
Supports FFR to increase initial medical therapy in NSTEMI; extends evidence for physiology-guided decisions in ACS.
Key Points
- To evaluate whether fractional flow reserve (FFR)-guided management optimizes treatment selection and clinical outcomes compared with standard visual angiography in patients with non-ST-segment elevation myocardial infarction (NSTEMI).
- Conducted a prospective, multicenter, parallel-group, 1:1 randomized controlled trial across six UK hospitals (NCT01764334) enrolling 350 NSTEMI patients with ≥1 coronary stenosis ≥30% diameter.
- Assigned patients to FFR-guided management with disclosure of values to the operator (n = 176) or angiography-guided care where FFR was measured but concealed (n = 174), using FFR ≤0.80 as the revascularization threshold.
- Followed patients over 12 months to assess management strategy reallocations, total revascularization rates, health outcomes, and quality of life.
- Initial management with medical therapy alone was significantly higher in the FFR-guided group than the angiography-guided group (22.7% [40/176] vs. 13.2% [23/174], difference 9.5% [95% CI: 1.4% to 17.7%], P = 0.022).
- Disclosure of FFR values prompted a change in treatment strategy among medical therapy, percutaneous coronary intervention, or coronary artery bypass surgery in 21.6% (38/176) of patients.
- At 12 months, revascularization remained lower in the FFR-guided group (79.0% vs. 86.8%, difference 7.8% [95% CI: -0.2% to 15.8%], P = 0.054), with no significant differences observed in health outcomes or quality of life.
Structured PICO
Does fractional flow reserve (FFR)-guided management increase the proportion of patients treated initially by medical therapy compared to angiography-guided standard care in NSTEMI patients?
P
Population
350 NSTEMI patients with ≥1 coronary stenosis ≥30% of the lumen diameter assessed visually, enrolled in six UK hospitals.
I
Intervention
Fractional flow reserve (FFR)-guided management, where FFR was disclosed to the operator and FFR ≤0.80 was an indication for revascularization by PCI or CABG.
C
Comparator
Angiography-guided standard care, where FFR was measured but not disclosed to the operator.
O
Outcome
Proportion of patients treated initially by medical therapy.surrogate
In NSTEMI patients, FFR-guided management safely increases the proportion of patients treated with medical therapy alone compared to standard angiography-guided management.
Limitations
- Trial not powered to assess health outcomes and cost-effectiveness
Cite This Study
Layland et al. (2014) studied this question.