Patients’ characteristics
| Clinical parameters | All | No bleeding | IR bleeding (non-adj.) | Adj. minor bleeding | Adj. major bleeding | Adj. bleeding (fatal/n.fatal) | Adj. bleeding ACM |
| N | 3339 | 1389 | 965 | 361 | 387 | 985 | 1156 |
| Age (years) | 57 (0.2) | 55 (0.3) | 57 (0.3) | 58 (0.5) | 61 (0.5) | 59 (0.3) | 59 (0.3) |
| Men (%) | 82 | 86 | 82 | 72 | 77 | 77 | 76 |
| Ancestry (white,%) | 88 | 88 | 88 | 89 | 88 | 89 | 89 |
| BMI (kg/m2) | 28 (0.1) | 28 (0.1) | 28 (0.1) | 27 (0.3) | 27 (0.2) | 27 (0.1) | 27 (0.1) |
| History of AP (%) | 56 | 51 | 56 | 59 | 65 | 61 | 61 |
| History of hypertension (%) | 38 | 35 | 41 | 38 | 46 | 40 | 41 |
| History of diabetes mellitus (%) | 13 | 13 | 12 | 13 | 17 | 15 | 17 |
| Invasive treatment arm (%) | 50 | 45 | 49 | 57 | 63 | 60 | 57 |
| Platelet count (×109/L)* | 285 (1.8) | 280 (2.1) | 291 (4.5) | 286 (4.8) | 284 (4.0) | 286 (2.6) | 286 (2.4) |
| Intravenous rt-PA dose (mg/first 6 hour) | 107 (0.3) | 106 (0.5) | 108 (0.7) | 106 (1.0) | 108 (1.0) | 107 (0.6) | 106 (0.6) |
| P rt-PA 50 min (nanogram/mL)† | 1745 (28.9) | 1667 (42.8) | 1750 (61.4) | 1780 (70.9) | 1924 (81.6) | 1850 (48.7) | 1899 (50.7) |
| Plasminogen 50 min (NP %)† | 68 (0.4) | 70 (0.7) | 67 (0.8) | 64 (1.3) | 64 (1.2) | 65 (0.8) | 65 (0.8) |
| Fibrinogen 8 hours (mg/dL)‡ | 185 (1.9) | 195 (2.9) | 185 (3.4) | 170 (5.4) | 170 (5.5) | 173 (3.4) | 175 (3.2) |
| FDP 8 hours (μg/mL)‡ | 292 (16.7) | 233 (23.1) | 260 (21.9) | 373 (63.4) | 455 (61.6) | 400 (39.4) | 398 (35.9) |
| Heparin dose (U/day)§ | 20 532 (98.6) | 21 107 (145.0) | 20 359 (170.1) | 19 098 (295.0) | 19 768 (369.3) | 19 895 (202.0) | 19 334 (201.1) |
| Aspirin dose (mg/day)§ | 217 (2.8) | 211 (3.1) | 214 (5.2) | 223 (9.5) | 240 (11.8) | 230 (6.6) | 227 (6.0) |
| CKmax (times URL) | 13 (0.2) | 12 (0.3) | 14 (0.4) | 15 (0.7) | 16 (1.3) | 16 (0.6) | 16 (0.5) |
| Maximum CK (IU/L)¶ | 55 890 | 20 000 | 17 050 | 22 560 | 55 890 | 55 890 | 55 890 |
Patients by bleeding category, respectively all patients; patients without bleeding; patients with IR, non-adjudicated (adj.) bleeding; patients with adjudicated minor, major and total adjudicated non-surgery-related fatal or non-fatal (n.fatal) bleeding events (primary outcome); and combined adjudicated bleeding events and all-cause mortality (ACM) (secondary outcome). Data are rounded means (standard errors), unless indicated otherwise. CKmax, maximum CK level per patient (mean), expressed as times the upper reference limit (URL, n=3327); Maximum CK refers to highest CK measured per group.
*At baseline, n=2860.
†P rt-PA n=1660, plasminogen n=1484.
‡At 8 hours after treatment initiation, fibrinogen n=1695, FDP n=1670.
§Mean dose during hospitalisation.
¶CK peak value.
AP, angina pectoris; BMI, body mass index; CK, Creatine kinase; FDP, fibrin(ogen) degradation product; IR, investigator reported; NP, % of normal pool; (P) rt-PA, (Plasma) recombinant tissue-type plasminogen activator; URL, upper reference limit.