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Table 1 Main characteristics of the cohort

From: Guideline-concordant administration of prothrombin complex concentrate and vitamin K is associated with decreased mortality in patients with severe bleeding under vitamin K antagonist treatment (EPAHK study)

Variable All patients (N = 822) Alive (N = 712) Dead (N = 110) P
Age (yrs) 77 ± 11 77 ± 11 80 ± 9 0.020
  ≤65 129 (16%) 119 (17%) 10 (9%) 0.033
  66 to 75 144 (17%) 131 (18%) 13 (12%)  
  76 to 85 368 (45%) 310 (44%) 58 (53%)  
  >85 181 (22%) 152 (21%) 29 (26%)  
Men 468 (57%) 408 (57%) 60 (55%) 0.587
Women 354 (43%) 304 (43%) 50 (45%)  
Type of VKA treatment     
  Fluindione 631 (77%) 535 (75%) 96 (87%) 0.005
  Acenocoumarol 99 (12%) 91 (13%) 8 (7%) 0.098
  Warfarin 85 (10%) 80 (11%) 5 (5%) 0.032
  Missing data 7 6 1  
Indication for VKA treatment*     
  Atrial fibrillation 555 (68%) 470 (66%) 85 (78%) 0.013
  Venous thromboembolic disease 156 (19%) 143 (20%) 13 (12%) 0.043
  Prosthetic heart valve 102 (12%) 89 (13%) 13 (12%) 0.850
  Others 79 (10%) 66 (9%) 13 (12%) 0.386
Duration of VKA treatment     
  <1 year 137 (17%) 124 (18%) 13 (13%) 0.223
  1 to 5 years 236 (30%) 207 (30%) 29 (29%) 0.846
  >5 years 426 (53%) 367 (52%) 59 (58%) 0.272
  Missing data 23 14 9  
Antiplatelet treatment** 153 (19%) 132 (19%) 21 (19%) 0.895
  Aspirin 125 (15%) 107 (15%) 18 (16%) 0.688
  Clopidogrel 34 (4%) 31 (4%) 3 (3%) 0.694
  Missing data 1 1 0  
History of severe hemorrhage** 103 (13%) 93 (13%) 10 (10%) 0.331
Missing data 10 3 7  
Type of hemorrhage     
  Intracranial 262 (32%) 176 (25%) 86 (78%) <0.001
  Gastrointestinal 264 (32%) 253 (36%) 11 (10%) <0.001
  Deep-muscle hematomas 107 (13%) 103 (15%) 4 (4%) <0.001
  “Other”*** 189 (23%) 180 (25%) 9 (8%) <0.001
  Missing data 0 0 0  
SAP (mmHg) 135 ± 36 131 ± 33 154 ± 47 <0.001
SAP     
  Hypertension >140 mmHg 334 (41%) 263 (37%) 71 (66%) <0.001
  Normotension 90 to 140 mmHg 411 (50%) 386 (54%) 25 (23%) <0.001
  Hypotension <90 mmHg 74 (9%) 62 (9%) 12 (11%) <0.001
  Missing data 3 1 2  
GCS 15 [15] 15 [15] 9 [4-15] <0.001
GCS     
  >13 684 (84%) 648 (92%) 36 (33%) <0.001
  9 to 13 65 (8%) 45 (6%) 20 (19%) <0.001
  ≤8 64 (8%) 12 (2%) 52 (48%) <0.001
  Missing data 9 7 2  
Admission INR 4.7 ± 3.4 4.7 ± 3.5 4.4 ± 2.7 0.236
  Normal (≤1.5) 45 (5%) 40 (6%) 5 (5%) 0.385
  Therapeutic (>1.5 to 4) 394 (48%) 341 (48%) 53 (48%)  
  Supratherapeutic (>4) 345 (42%) 300 (42%) 45 (41%)  
  Missing value 38 (5%) 31 (4%) 7 (6%)  
VKA reversal treatment     
  No guideline-concordant     
  Level 0 361 (44%) 299 (42%) 62 (56%) 0.06
  Level 1 103 (13%) 92 (13%) 11 (10%)  
  Level 2 34 (4%) 32 (5%) 2 (2%)  
  Guideline-concordant     
  Level 3 90 (11%) 85 (12%) 5 (5%)  
  Level 4 217 (26%) 190 (27%) 27 (25%)  
VKA reversal treatment     
  Not guideline-concordant (Levels 0 + 1 + 2) 509 (62%) 432 (61%) 77 (70%) 0.06
  Guideline-concordant (Levels 3 + 4) 313 (38%) 280 (39%) 33 (30%)  
  1. Data are mean ± SD, median [25th to 75th percentiles], or number (percentage). P- values refer to comparison between alive and dead patients at Day 7.
  2. INR, international normalized ratio; SAP, systolic arterial blood pressure; GCS, Glasgow coma scale; VKA, vitamin K antagonist.
  3. *The sum is higher than 100% because two indications can be established for the same patient.
  4. **Patients with no antiplatelet treatment or no history of severe hemorrhage are deducted from the presented results.
  5. ***“Other” types include hemopericardium (N = 1), hemothorax (N = 15), vascular bound (N = 4), emergency procedures (N = 126) and shock or red blood cells transfusion for epistaxis (N = 55), hematuria (N = 34) or wound of the scalp (N = 4).