Table 2 Primary and secondary endpoints
|  | Raw cohort (n = 7135) | Propensity score matched cohort (n = 1324) | ||||||
|---|---|---|---|---|---|---|---|---|
Indobufen group (n = 689) | Aspirin group (n = 6446) | HR (95% CI) | P | Indobufen group (n = 662) | Aspirin group (n = 662) | HR (95% CI) | P | |
Primary endpoints | ||||||||
 MACCE | 45 (6.5%) | 406 (6.3%) | 1.04 (0.76, 1.41) | 0.812 | 43 (6.5%) | 43 (6.5%) | 0.99 (0.65, 1.52) | 0.978 |
 BARC type 2, 3, or 5 bleeding | 21 (3.0%) | 418 (6.5%) | 0.46 (0.30, 0.72) | 0.001 | 20 (3.0%) | 79 (11.9%) | 0.24 (0.15, 0.40) |  < 0.001 |
Secondary endpoints | ||||||||
 Cardiovascular death, nonfatal MI, stent thrombosis, or nonfatal ischemic stroke | 19 (2.8%) | 130 (2.0%) | 1.37 (0.85, 2.22) | 0.199 | 17 (2.6%) | 16 (2.4%) | 1.06 (0.54, 2.10) | 0.862 |
 All-cause death | 11 (1.6%) | 53 (0.8%) | 1.95 (1.02, 3.73) | 0.044 | 10 (1.5%) | 5 (0.8%) | 2.01 (0.69, 5.87) | 0.204 |
 Cardiovascular death | 5 (0.7%) | 26 (0.4%) | 1.80 (0.69, 4.70) | 0.227 | 4 (0.6%) | 4 (0.6%) | 1.00 (0.25, 4.01) | 0.998 |
 Nonfatal MI | 3 (0.4%) | 56 (0.9%) | 0.50 (0.16, 1.60) | 0.244 | 3 (0.5%) | 7 (1.1%) | 0.43 (0.11, 1.66) | 0.220 |
 Repeated revascularization | 29 (4.2%) | 316 (4.9%) | 0.86 (0.59, 1.26) | 0.435 | 29 (4.4%) | 33 (5.0%) | 0.88 (0.53, 1.44) | 0.604 |
 Stent thrombosis | 2 (0.3%) | 20 (0.3%) | 0.94 (0.22, 4.00) | 0.928 | 2 (0.3%) | 2 (0.3%) | 1.00 (0.14, 7.10) | 1.000 |
 Nonfatal ischemic stroke | 4 (0.6%) | 21 (0.3%) | 1.79 (0.61, 5.21) | 0.286 | 3 (0.5%) | 4 (0.6%) | 0.75 (0.17, 3.36) | 0.707 |
 NACE | 65 (9.4%) | 781 (12.1%) | 0.76 (0.59, 0.98) | 0.035 | 62 (9.4%) | 113 (17.1%) | 0.52 (0.38, 0.70) |  < 0.001 |
 BARC defined bleeding | ||||||||
  Type 1 | 60 (8.7%) | 612 (9.5%) | 0.91 (0.70, 1.19) | 0.488 | 52 (7.9%) | 106 (16.0%) | 0.47 (0.34, 0.65) |  < 0.001 |
  Type 2 | 11 (1.6%) | 266 (4.1%) | 0.38 (0.21, 0.70) | 0.002 | 10 (1.5%) | 47 (7.1%) | 0.21 (0.11, 0.41) |  < 0.001 |
  Type 3 | 10 (1.5%) | 145 (2.3%) | 0.64 (0.34, 1.22) | 0.176 | 10 (1.5%) | 28 (4.2%) | 0.35 (0.17, 0.73) | 0.005 |
  Type 5 | 0 (0.0%) | 7 (0.1%) | / | 0.387* | 0 (0.0%) | 4 (0.6%) | / | 0.045* |
  Minor (type 1 or 2) | 71 (10.3%) | 878 (13.6%) | 0.74 (0.58, 0.95) | 0.016 | 62 (9.4%) | 153 (23.1%) | 0.37 (0.28, 0.50) |  < 0.001 |
  Major (type 3 or 5) | 10 (1.5%) | 152 (2.4%) | 0.61 (0.32, 1.16) | 0.133 | 10 (1.5%) | 32 (4.8%) | 0.31 (0.15, 0.63) | 0.001 |
  Bleeding site | ||||||||
   Subcutaneous | 30 (4.4%) | 403 (6.3%) | 0.72 (0.52, 0.99) | 0.046 | 27 (4.1%) | 64 (9.7%) | 0.43 (0.30, 0.62) |  < 0.001 |
   Gastrointestinal | 37 (5.4%) | 500 (7.8%) | 0.54 (0.39, 0.75) | 0.023 | 33 (5.0%) | 82 (12.4%) | 0.34 (0.17, 0.68) |  < 0.001 |
   Urogenital | 3 (0.4%) | 31 (0.5%) | 0.98 (0.17, 5.65) | 0.868 | 2 (0.3%) | 8 (1.2%) | 0.79 (0.47, 1.33) | 0.107 |
   Intracranial | 0 (0.0%) | 4 (0.4%) | / | 0.513* | 0 (0.0%) | 1 (0.2%) | / | 0.317* |
   Other | 11 (1.6%) | 92 (1.4%) | 0.97 (0.23, 4.10) | 0.930 | 10 (1.5%) | 30 (4.5%) | 0.32 (0.14, 0.73) | 0.001 |
 TIMI defined bleeding | ||||||||
  Minimal | 70 (10.2%) | 893 (13.9%) | 0.72 (0.56, 0.92) | 0.008 | 61 (9.2%) | 156 (23.6%) | 0.36 (0.27, 0.48) |  < 0.001 |
  Minor | 7 (1.0%) | 107 (1.7%) | 0.61 (0.28, 1.31) | 0.206 | 7 (1.1%) | 22 (3.3%) | 0.32 (0.14, 0.74) | 0.008 |
  Major | 4 (0.6%) | 30 (0.5%) | 1.25 (0.44, 3.54) | 0.677 | 4 (0.6%) | 7 (1.1%) | 0.57 (0.17, 1.94) | 0.368 |
 GUSTO defined bleeding | ||||||||
  Minor | 72 (10.4%) | 883 (13.7%) | 0.75 (0.59, 0.95) | 0.018 | 63 (9.5%) | 153 (23.1%) | 0.38 (0.28, 0.51) |  < 0.001 |
  Moderate | 3 (0.4%) | 98 (1.5%) | 0.29 (0.09, 0.90) | 0.032 | 3 (0.5%) | 21 (3.2%) | 0.14 (0.04, 0.47) | 0.002 |
  Severe or life-threatening | 6 (0.9%) | 49 (0.8%) | 1.15 (0.49, 2.67) | 0.753 | 6 (0.9%) | 11 (1.7%) | 0.54 (0.20, 1.47) | 0.227 |