Supplementary Data File
Fractional Flow Reserve versus Angiography in Guiding Management to
Optimise Outcomes in Non-ST-Segment Elevation Myocardial Infarction:
The British Heart Foundation FAMOUS–NSTEMI randomised trial.
1
FFR-guided vs. Angiography-guided treatment groups
Relationships between lesion classification by angiography alone vs. angiography with FFR
FFR was measured in at least one artery in all (100%) patients. 706 lesions (n=354 in the
FFR-guided group and n=351 in the angiography-guided group) had a diameter stenosis
severity ≥ 30% based on visual interpretation of the coronary angiogram and FFR was
measured in 704 (99.7%) of these lesions. Two patients with multivessel disease lacked an
FFR measurement in a diseased side branch.
Based on visual assessment of the coronary angiogram, 645 lesions (91.4%) had a diameter
stenosis severity ≥ 50% and 496 (70.3%) had a diameter stenosis severity ≥ 70%. Of 704
lesions with an FFR result, 430 (61.1%) were functionally significant (FFR ≤ 0.80) (Table 2).
Ten patients (2.9%) had no lesions (stenosis severity < 50%) when assessed by angiography
and 63 (18·0%) patients had no lesions when subsequently assessed by FFR (> 0.80). The
proportions of patients classified with 0, 1, 2, or 3 vessel disease in each group is shown in
Figure 1.
2
Relationship between FFR and time to the index procedure.
Table 1.
Time from index event to procedure
FFR
>3 days
≤3 days
n; mean FFR (SD)
n; mean FFR (SD)
p
Segments
336; 0.71 (0.18)
368; 0.68 (0.18)
0.063
Vessel Groups
326; 0.70 (0.18)
358; 0.68 (0.18)
0.095
Arteries
306; 0.70 (0.19)
338; 0.67 (0.18)
0.065
Patients
166; 0.62 (0.18)
184; 0.57 (0.15)
0.008
These results show that FFR tend to be lower in patients assessed ≤3 days from the index
event to the procedure compared to in patients assessed > 3 days.
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Serious adverse cardiovascular events in patients treated with medical therapy only
Sixty three (18·0%) patients were treated with medical therapy, of whom 40 (22.7%) were randomly assigned to the FFR-guided group and 23 (13.2%) were
randomised to the angiography-guided group. During 12 months follow-up 3/40 (7.5%) in the FFR-guided group had a MACE event during 12 months followup vs. 0/23 (0%) in the angiography-guided group (difference 7.5% (confidence interval -7.4%, 20.7%); p=0.22).
Table 2. Adverse events in the medically-managed participants. All of these events occurred in participants randomised to the FFR-guided group.
Participant
(age, sex)
60, male
Invasive findings for culprit
lesion (location, angiographic
stenosis severity)
Invasive findings for non-culprit
lesion (location, angiographic
stenosis severity)
Initial treatment
plan based on the
angiogram
FFR result and
treatment plan
after FFR
disclosure
Adverse cardiovascular event and
treatment*
Intermediate artery, 70%
focal stenosis, FFR = 0.86
No lesions
PCI
Medical therapy
NSTEMI 7 weeks after
randomisation
PCI performed to culprit
intermediate artery stenosis despite
FFR > 0.80.
49, male
46, male
Proximal circumflex, 70%
stenosis
Right coronary artery, 100%
stenosis
Mid left anterior descending
artery, 60% stenosis
Mid left anterior descending
artery, 60% stenosis
PCI
CABG
Circumflex artery
FFR = 0.94,
NSTEMI 8 months after
randomisation
Left anterior
descending artery
FFR = 0.83;
Medical therapy
Medical management.
FFR = 0.87
Severe left ventricular dysfunction
at baseline (LV ejection fraction <
30%) but no implantable
Medical therapy
4
defibrillator; sudden cardiac death
63, male
Proximal left anterior
descending coronary artery,
75% focal stenosis.
No lesions
PCI to culprit
lesion
FFR = 0.86
Medical therapy
Coronary guidewire related
dissection during the index
procedure; FFR-guided decision for
medical therapy changed to PCI in
order to treat the dissection.
PCI was performed but MI did not
occur.
*Adverse cardiovascular events were assessed and adjudicated by a clinical event committee. The committee included 3 cardiologists who were independent of
the study and blind to treatment group assignment. De-identified source clinical data were provided to the committee members.
5
Revascularisation within 12 months
Compared with the angiography-guided group, the percentage of patients who were
free from coronary revascularisation remained higher in the FFR disclosure group at 12
months (37 (21.0%) vs. 23 (13.2%), difference 7.8% (-0.2%, 15.8%), p=0.054; relative risk
1.59 (0.99, 2.62)).
The results for revascularisation from randomisation at baseline to 12 months
according to procedure type (PCI or CABG) are shown in Table 3.
Table 3. Revascularisation by PCI or CABG at 12 months
FFR
Angio
Risk Diff
p-value
PCI
128 (72.7%)
139 (79.9%)
-7.2% (-16.2%, 1.8%)
p=0.12
CABG
11 (6.2)
12 (6.9%)
-0.7% (-6.2%, 4.8%)
p=0.87
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Supplementary Figure Legends
Figure 1.
The proportions of patients with 0, 1, 2, or 3 vessel disease in the
angiography-guided and FFR-guided groups. The number of patients with 1, 2, or ≥ 3 vessel
coronary disease was 130 (37.1%), 141 (40.3%) and 69 (19.8%) when assessed by
angiography (stenosis severity ≥ 50%), and 181 (51.7%), 81 (23.1%), and 25 (7.2%) patients
when assessed by FFR (≤ 0.80).
Figure 2.
Relationship between angiographic stenosis severity assessed visually before
randomisation and FFR for culprit lesions (A) and non-culprit lesions (B). Culprit lesion
status was determined by the cardiologist based on all of the clinical data including the
angiogram, before FFR was measured.
Figure 3.
Kaplan-Meier plots for major adverse cardiac events (MACE) during 12
months follow-up in the FFR-guided group and angiography-guided group. MI events
associated with revascularisation (Types IV and V MI) are excluded so the MACE outcome
includes spontaneous MI events post-randomisation only.
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Figure 1.
8
Figure 2.
(a) Culprit lesions: FFR vs. stenosis severity
(b) Non-culprit lesions: FFR vs. stenosis severity.
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Figure 3.
10