Table 4.
Plaque Volumea | Controls | Omega‐3 Ethyl‐Ester | % Change From Baseline | ||||
---|---|---|---|---|---|---|---|
Baseline Value Median [IQR] | 30‐Month Value Median [IQR] | Baseline Value Median [IQR] | 30‐Month Value Median [IQR] | Controls Median [IQR] | Omega‐3 Ethyl‐Ester Median [IQR] | P Valueb | |
Intention‐to‐treat | |||||||
(n=114) | (n=126) | ||||||
Fatty | 8.6 [5.1, 14.0] | 8.6 [5.3, 13.7] | 9.4 [4.9, 14.7] | 9.3 [5.5, 14.8] | 2.9 [−9.8, 15.1] | 0.8 [−10.4, 20.1] | 0.94 |
Fibrous | 15.1 [8.7, 23.0] | 15.9 [9.2, 23.5] | 17.5 [9.5, 25.5] | 16.1 [9.7, 24.3] | 4.6 [−8.0, 18.5] | 0.1 [−12.2, 14.9] | 0.063 |
Noncalcified | 23.7 [14.3, 36.8] | 24.7 [14.5, 36.6] | 26.4 [14.3, 39.7] | 25.7 [15.0, 39.9] | 4.5 [−6.1, 15.8] | −2.4 [−9.8, 16.7] | 0.14 |
Calcified | 3.6 [1.3, 7.3] | 6.2 [2.6, 10.3] | 5.0 [2.4, 8.7] | 6.4 [3.3, 10.3] | 57.4 [4.3, 146.6] | 39.1 [−5.2, 118.1] | 0.18 |
Total | 28.1 [16.6, 44.3] | 33.8 [18.1, 46.5] | 33.2 [17.9, 47.0] | 33.4 [19.1, 50.5] | 10.0 [−3.1, 25.9] | 6.5 [−6.9, 19.2] | 0.11 |
Per‐protocol | |||||||
(n=97) | (n=122) | ||||||
Fatty | 9.6 [5.1, 14.1] | 9.6 [5.3, 14.2] | 9.7 [4.9, 15.0] | 9.3 [5.5, 14.8] | 0.2 [−8.9, 13.0] | 0.4 [−10.6, 20.0] | 0.99 |
Fibrous | 16.0 [9.0, 23.5] | 17.1 [9.3, 23.9] | 17.7 [9.5, 25.7] | 16.1 [9.7, 24.3] | 5.0 [−5.7, 20.0] | −0.1 [−12.3, 14.5] | 0.018 |
Noncalcified | 26.9 [14.3, 37.2] | 26.0 [14.9, 36.9] | 27.1 [14.3, 40.0] | 25.7 [15.0, 39.9] | 4.4 [−5.9, 16.0] | −2.7 [−10.3, 16.4] | 0.072 |
Calcified | 3.7 [1.5, 7.6] | 6.3 [3.0, 10.5] | 5.1 [2.6, 8.7] | 6.4 [3.7, 10.3] | 59.2 [6.2, 154.1] | 39.1 [−3.8, 121.4] | 0.16 |
Total | 30.9 [16.4, 45.7] | 34.6 [18.6, 47.2] | 33.9 [17.9, 47.4] | 33.4 [19.3, 51.3] | 9.9 [−3.3, 27.1] | 6.3 [−7.4, 18.7] | 0.087 |
Plaque volume expressed as mm3/mm.
P values calculated using a Mann–Whitney U test.
IQR indicates interquartile range.