|
Patients with QFR increase
|
50 (53% [43-63]) |
40 (40% [31-50]) |
13% (–2 to 28)
|
1.7 (0.9-3.0)
|
0.076
|
|
Primary endpoint Patients with QFR ≤0.95
|
N=57
|
N=50
|
|
|
Patients with QFR increase
|
37 (65% [52-76])
|
22 (44% [31-58])
|
20.9% (0.5-41.0)
|
2.4 (1.1 to 5.2)
|
0.031
|
|
Secondary endpoints [all patients (vessels)]
|
Baseline
|
1-year follow-up
|
Change between baseline and 1-year follow-up
|
|
Alirocumab [N=94 (133)]
|
Placebo [N=99 (149)]
|
p-value
|
Alirocumab [N=94 (133)]
|
Placebo [N=99 (149)]
|
Alirocumab [N=94 (133)]
|
Placebo [N=99 (149)]
|
Difference in change
|
p-value
|
|
QFR
|
0.96 (0.91-0.98)
|
0.96
(0.91-0.99)
|
0.593
|
0.96
(0.92-0.98)
|
0.95
(0.89-0.98)
|
0.00
(–0.02 to 0.02)
|
–0.01
(–0.03 to –0.01)
|
-
|
-
|
|
Diameter stenosis, %
|
36.96±7.88
|
36.63±8.46
|
0.742
|
35.93±9.58
|
38.33±11.31
|
–1.03±7.28
|
1.70±8.27
|
−2.50
(−4.43 to −0.57)
|
0.011
|
|
Area stenosis, %
|
50.18±12.69
|
49.64±12.32
|
0.715
|
48.84±14.06
|
51.50±14.94
|
–1.35±11.68
|
1.86±11.74
|
−2.80
(−5.73 to 0.14)
|
0.062
|
|
Lesion length, mm
|
18.45±9.94
|
18.45±10.23
|
0.999
|
18.22±9.84
|
17.92±9.21
|
–0.23±8.29
|
–0.53±9.46
|
0.37
(−1.83 to 2.58)
|
0.739
|
|
Proximal diameter, mm
|
3.05±0.58
|
2.85±0.63
|
0.006
|
3.01±0.57
|
2.83±0.57
|
–0.05±0.31
|
–0.00±0.28
|
−0.02
(−0.10 to 0.05)
|
0.520
|
|
Minimum lumen diameter, mm
|
2.00±0.53
|
1.82±0.52
|
0.004
|
1.99±0.53
|
1.76±0.56
|
–0.01±0.26
|
–0.06±0.28
|
0.05
(−0.02 to 0.12)
|
0.130
|
|
Distal diameter, mm
|
2.88±0.68
|
2.57±0.63
|
<0.001
|
2.85±0.95
|
2.56±0.60
|
–0.03±0.68
|
–0.01±0.28
|
−0.02
(−0.10 to 0.05)
|
0.520
|
|
For the primary endpoint analyses, values are count (%). Patients with a QFR increase are those whose mean change in contrast vessel QFR across vessels is positive. The odds ratio (OR), associated 95% confidence interval (CI) and corresponding p-values were computed using a logistic model. For secondary endpoint analyses, p-values for continuous QFR at baseline are from Wilcoxon tests. For other variables, values are mean (SD) across vessels and differences in change are marginal differences with robustified 95% CIs and p-values computed using repeated mixed-effect models accounting for multiple vessels imaged per patient. Samples sizes correspond to number of patients (vessels). As per substudy design, vessels with diameter stenosis ≤25% were excluded. 3D: three-dimensional; QFR: quantitative flow ratio; SD: standard deviation
|
