Variable | Number (% missing) | Overall (n = 150) | Prior history of thrombosis (n = 98) | Without prior history of thrombosis (n = 52) | p a | No event during follow-up (n = 118) | Event during follow-up (n = 32) | p a |
---|---|---|---|---|---|---|---|---|
Demographic characteristics | ||||||||
 Age at entry (years) | 150 (0.0%) | 41.3 [32.3-60.2] | 39.2 [29.9-54.7] | 48.4 [35.6-62.9] | 0.014 | 40.1 [31.8-58.2] | 46.0 [32.5-63.8] | 0.210 |
 Female gender | 150 (0.0%) | 122 (81.3%) | 82 (83.7%) | 40 (76.9%) | 0.313 | 98 (83.1%) | 24 (75.0%) | 0.300 |
 BMI (kg/m2) | 147 (2.0%) | 25.4 [22.5-29.4] | 25.6 [22.4-29.9] | 25.1 [22.8-28.9] | 0.659 | 25.0 [22.2-29.3] | 27.5 [24.6-30.1] | 0.054 |
Clinical history | ||||||||
 Prior history of thrombosis | 150 (0.0%) | 98 (65.3%) | - | - | - | 77 (65.3%) | 21 (65.6%) | 0.969 |
-Arterial | 150 (0.0%) | 21 (14.0%) | - | - | - | 15 (12.7%) | 6 (18.8%) | 0.383 |
-Venous | 150 (0.0%) | 84 (56.0%) | - | - | - | 68 (57.6%) | 16 (50.0%) | 0.441 |
-Both | 150 (0.0%) | 7 (4.7%) | - | - | - | 6 (5.1%) | 1 (3.1%) | 0.538 |
 Prior history of pregnancy complicationsb | 94 (0.0%) | 40 (42.6%) | - | - | - | 32 (42.7%) | 8 (42.1%) | 0.965 |
 Established APS | 150 (0.0%) | 111 (74.0%) | 98 (100.0%) | 13 (25.0%) | <0.0001 | 89 (75.4%) | 22 (68.8%) | 0.445 |
 Family history of thrombosis | 150 (0.0%) | 48 (32.0%) | 33 (33.7%) | 15 (28.9%) | 0.546 | 40 (33.9%) | 8 (25.0%) | 0.339 |
Comorbidities | ||||||||
 Hypertension | 150 (0.0%) | 44 (29.3%) | 26 (26.5%) | 18 (34.6%) | 0.301 | 34 (28.8%) | 10 (31.3%) | 0.788 |
 Diabetes | 150 (0.0%) | 10 (6.7%) | 5 (5.1%) | 5 (9.6%) | 0.292 | 4 (3.4%) | 6 (18.8%) | 0.002 |
 Statin exposure | 150 (0.0%) | 10 (6.7%) | 8 (8.2%) | 2 (3.9%) | 0.313 | 7 (5.9%) | 3 (9.4%) | 0.445 |
 Autoimmune rheumatic diseasesc | 150 (0.0%) | 48 (32.0%) | 31 (31.7%) | 17 (32.7%) | 0.895 | 39 (33.1%) | 9 (28.1%) | 0.596 |
-SLE | 150 (0.0%) | 29 (19.3%) | 20 (20.4%) | 9 (17.3%) | 0.647 | 24 (20.3%) | 5 (15.6%) | 0.549 |
-LLD | 150 (0.0%) | 19 (12.7%) | 11 (11.2%) | 8 (15.4%) | 0.466 | 15 (12.7%) | 4 (12.5%) | 0.975 |
 Thrombophiliad | 150 (0.0%) | 47 (31.3%) | 30 (30.6%) | 17 (32.7%) | 0.794 | 35 (29.7%) | 12 (37.5%) | 0.396 |
 Active smoker at baseline | 150 (0.0%) | 45 (30.0%) | 25 (25.5%) | 20 (38.5%) | 0.099 | 30 (25.4%) | 15 (46.9%) | 0.019 |
Anticoagulation at baseline | ||||||||
 VKA | 150 (0.0%) | 70 (46.7%) | 68 (69.4%) | 2 (3.9%) | <0.0001 | 55 (46.6%) | 15 (46.9%) | 0.979 |
 Low molecular weight heparin (LMWH) | 150 (0.0%) | 14 (9.3%) | 11 (11.2%) | 3 (5.8%) | 0.381 | 14 (11.9%) | 0 (0.0%) | 0.041 |
 Low dose aspirin (LDA) | 150 (0.0%) | 37 (24.7%) | 24 (24.5%) | 13 (25.0%) | 0.945 | 29 (24.6%) | 8 (25.0%) | 0.961 |
 None | 150 (0.0%) | 54 (36.0%) | 17 (17.4%) | 37 (71.2%) | <0.0001 | 43 (36.4%) | 11 (34.4%) | 0.829 |
Disease-defining autoantibodies | ||||||||
 aPTT-LA (s) | 150 (0.0%) | 87.4 [70.1-117.5] | 90.2 [72.5-118.1] | 82.8 [64.9-115.6] | 0.165 | 85.9 [69.0-109.3] | 115.0 [74.4-132.5] | 0.040 |
 aPTT-LA ratioe | 150 (0.0%) | 2.6 [2.1-3.4] | 2.6 [2.1-3.5] | 2.4 [1.9-3.9] | 0.165 | 2.5 [2.0-3.2] | 3.4 [2.2-3.9] | 0.041 |
 aβ2-GPI IgM (MPL) | 148 (1.3%) | 5.6 [2.8-15.7] | 5.1 [2.5-14.6] | 7.1 [3.0-26.7] | 0.197 | 5.3 [2.6-15.5] | 7.1 [3.2-17.1] | 0.412 |
 aβ2-GPI IgG (GPL) | 149 (0.7%) | 9.8 [2.3-50.0] | 18.9 [3.1-68.5] | 5.5 [1.7-17.0] | 0.005 | 9.4 [2.3-48.6] | 16.3 [2.6-81.0] | 0.522 |
 aCL IgM (MPL) | 150 (0.0%) | 9.1 [3.7-23.0] | 7.6 [3.4-16.2] | 13.1 [5.1-32.3] | 0.001 | 8.7 [3.5-21.1] | 10.6 [5.5-25.5] | 0.286 |
 aCL IgG (GPL) | 150 (0.0%) | 19.1 [6.3-71.7] | 35.1 [8.9-99.9] | 10.8 [5.5-29.9] | 0.037 | 18.4 [6.0-65.9] | 26.6 [7.0-111.9] | 0.236 |
 LA alone | 150 (0.0%) | 42 (28.4%) | 23 (23.7%) | 19 (37.3%) | 0.082 | 34 (29.3%) | 8 (25.0%) | 0.632 |
 LA + aβ2-GPI (ISTH cut-off)f | 148 (1.3%) | 105 (71.0%) | 73 (75.3%) | 32 (62.8%) | 0.111 | 81 (69.8%) | 24 (75.0%) | 0.568 |
 LA + aCL (ISTH cut-off)f | 150 (0.0%) | 67 (44.7%) | 51 (52.0%) | 16 (30.8%) | 0.013 | 50 (42.4%) | 17 (53.1%) | 0.278 |
 Triple positivity (ISTH cut-off)f | 148 (1.3%) | 64 (43.2%) | 49 (50.5%) | 15 (29.4%) | 0.014 | 47 (40.5%) | 17 (53.1%) | 0.202 |
 Triple positivity (Padova cut-off)f | 148 (1.3%) | 87 (58.8%) | 59 (60.8%) | 28 (54.9%) | 0.487 | 66 (56.9%) | 21 (65.6%) | 0.375 |
 Triple positivity (local cut-off)f | 148 (1.3%) | 93 (62.8%) | 64 (66.0%) | 29 (56.9%) | 0.275 | 72 (62.1%) | 21 (65.6%) | 0.712 |
LA-related autoantibodies | ||||||||
 Domain I abs (CU) | 144 (6.0%) | 30.3 [2.5-256.0] | 64.3 [4.1-498.2] | 5.9 [1.5-59.9] | 0.002 | 30.8 [3.2-245.3] | 24.8 [1.5-265.4] | 0.580 |
 Anti-protein Z IgM | 144 (4.0%) | 6.0 [4.1-9.1] | 5.5 [3.8-8.8] | 6.3 [4.6-9.6] | 0.210 | 5.9 [4.1-9.3] | 6.0 [4.4-8.9] | 0.651 |
 Anti-protein Z IgG | 144 (4.0%) | 3.4 [2.6-5.7] | 3.4 [2.6-6.0] | 3.3 [2.5-5.6] | 0.584 | 3.4 [2.6-5.6] | 3.4 [2.4-6.0] | 0.888 |
 Antiprothrombin IgM | 146 (2.7%) | 5.4 [3.2-10.1] | 5.2 [2.6-8.5] | 6.5 [3.7-13.3] | 0.031 | 5.4 [3.2-9.5] | 7.5 [3.6-11.0] | 0.331 |
 Antiprothrombin IgG | 146 (2.7%) | 4.5 [2.1-8.7] | 5.2 [1.7-11.2] | 4.1 [2.9-6.3] | 0.407 | 4.3 [2.0-8.7] | 5.8 [2.3-9.6] | 0.514 |
 Annexin A5 ratio (%) | 143 (4.7%) | 205 [175-250] | 193 [164-240] | 239 [186-258] | 0.001 | 218 [176-254] | 186 [164-239] | 0.164 |
Selected laboratory parameters | ||||||||
 C-reactive protein (mg/dL) | 148 (1.3%) | 0.1 [0.0-0.8] | 0.2 [0.0-1.0] | 0.1 [0.0-0.4] | 0.087 | 0.1 [0.0-0.7] | 0.4 [0.0-0.8] | 0.721 |
 Triglycerides (mg/dL) | 148 (1.3%) | 107 [82-153] | 110 [87-155] | 103 [70-150] | 0.354 | 106 [82-145] | 131 [82-191] | 0.197 |
 Cholesterol (mg/dL) | 149 (0.7%) | 196 [174-225] | 191 [168-221] | 203 [178-232] | 0.239 | 193 [172-221] | 202 [180-233] | 0.257 |
 HDL/LDL ratio | 144 (4.0%) | 0.45 [0.35-0.61] | 0.44 [0.35-0.60] | 0.49 [0.35-0.67] | 0.498 | 0.46 [0.35-0.63] | 0.43 [0.35-0.57] | 0.533 |
 Homocysteine (μmol/L) | 142 (5.3%) | 9.8 [8.4-13.7] | 9.7 [8.4-13.8] | 10.8 [8.6-13.0] | 0.484 | 9.8 [8.5-12.8] | 10.1 [8.2-15.5] | 0.519 |
 Fibrinogen (mg/dL) | 150 (0.0%) | 377 [318-430] | 390 [320-456] | 357 [297-399] | 0.011 | 370 [313-430] | 396 [355-442] | 0.169 |