Table 1.
Baseline characteristics and in-hospital management of 2754 study patients according to the occurrence or not of early major bleeding.
| All Study Patients (n = 2754) |
Missing Values (%) | Patients without Major Bleeding (n = 2672) |
Patients with Major Bleeding (n = 82) |
p Value | |
|---|---|---|---|---|---|
| Age, year | 67.3 ± 17.4 | 0 | 67.2 ± 17.4 | 70.2 ± 14.4 | 0.12 |
| Female sex (%) | 1414 (51.3) | 0 | 1362 (50.1) | 52 (63.4) | 0.03 |
| BMI, kg/m2 | 27.4 ± 5.9 | 0.2 | 27.4 ± 5.9 | 27.8 ± 7.4 | 0.59 |
| Comorbidities (%) | |||||
| Hypertension | 1300 (47.2) | 0.1 | 1258 (47.1) | 42 (51.2) | 0.45 |
| Diabetes mellitus | 366 (13.3) | 0.2 | 354 (13.2) | 12 (14.6) | 0.71 |
| Chronic pulmonary disease | 236 (8.6) | 0.3 | 23 (8.6) | 5 (6.1) | 0.41 |
| Coronary artery disease | 378 (13.7) | 0.2 | 365 (13.7) | 13 (15.5) | 0.56 |
| Active cancer a | 507 (18.4) | 0.1 | 490 (18.3) | 17 (20.7) | 0.58 |
| Prior stroke | 166 (6.0) | 0.1 | 157 (5.9) | 9 (11.0) | 0.09 |
| Prior VTE | 654 (23.8) | 0 | 631 (23.6) | 23 (3.5) | 0.35 |
| Prior bleeding | 42 (1.5) | 0.3 | 38 (1.4) | 4 (4.9) | 0.07 |
| Recent surgery b | 192 (7.0) | 0.2 | 181 (6.8) | 11 (13.4) | 0.02 |
| Concomitant medication usage predisposing to bleeding c | 112 (4.1) | 0.1 | 102 (3.8) | 10 (12.2) | 0.008 |
| Antiplatelet therapy | 93 (3.4) | - | 17 (0.6) | 3 (3.7) | - |
| Anticoagulant | 20 (0.7) | - | 86 (3.2) | 7 (8.5) | - |
| Low-risk for long-term recurrence | 702 (25.6) | 0.3 | 678 (25.4) | 24 (29.3) | 0.42 |
| Associated DVT | 1120 (40.7) | 1.1 | 1082 (40.5) | 38 (46.3) | 0.30 |
| Clinical characteristics | |||||
| HR at admission, bpm | 89.9 ± 19.1 | 0.6 | 89.8 ± 19.1 | 94.1 ± 9.8 | 0.04 |
| SBP at admission, mmHg | 137.7 ± 23.6 | 0.1 | 138.0 ± 23.4 | 131.6 ± 24.0 | 0.01 |
| SaO2 at admission, % | 93.4 ± 5.6 | 1.1 | 93.5 ± 5.3 | 90.4 ± 9.9 | <0.001 |
| Biological data | |||||
| Hemoglobin (g/dL) | 13.3 ± 2.9 | 1.0 | 13.4 ± 2.8 | 11.1 ± 2.8 | <0.001 |
| eGRFCKD-EPI, mmol/L | 75.9 ± 24.9 | 0.9 | 76.3 ± 24.9 | 62.2 ± 24.9 | <0.001 |
| Positive troponin | 981 (35.6) | 0.9 | 938 (35.1) | 43 (52.4) | 0.002 |
| Echo data | |||||
| RV dysfunction | 911 (33.1) | 1.1 | 871 (32.6) | 40 (48.8) | 0.003 |
| sPESI (median, Q1–Q3) | 2 (1–3) | 0.9 | 2 (1–3) | 3 (2–3) | 0.009 |
| ESC-defined risk PE category (%) | <0.001 | ||||
| Low-risk | 443 (16.1) | - | 438 (16.4) | 5 (6.1) | |
| Intermediate-low risk | 1594 (57.9) | - | 1550 (58.0) | 44 (53.7) | |
| Intermediate-high risk | 584 (21.2) | - | 563 (21.1) | 21 (25.6) | |
| High-risk | 133 (4.8) | - | 121 (4.5) | 12 (14.6) | |
| Bleeding scores (median, Q1–Q3) | |||||
| VTE-BLEED score | 2.5 (1.5–3.5) | - | 2.5 1 (1.5–3.5) | 3.0 (2.5–4.5) | <0.001 |
| RIETE score | 3 (2–4) | - | 1 (0–2) | 3.5 (3–4.5) | <0.001 |
| ORBIT score | 1 (0–2) | - | 1 (0–2) | 2 (1–3) | <0.001 |
| HAEMORR2HAGES score | 1 (0–1) | - | 1 (0–2) | 2 (1–2) | <0.001 |
| ATRIA score | 1 (0–3) | - | 1 (0–3) | 3 (2–5) | |
| HAS-BLED score | 1 (0–1) | - | 1 (0–1) | 1 (1–2) | 0.01 |
| In-hospital treatments (%) | |||||
| Anticoagulation | |||||
| UFH | 603 (21.9) | - | 559 (20.9) | 44 (53.7) | <0.001 |
| LMWH/fondaparinux | 1538 (42.3) | - | 1501(56.2) | 39 (44.0) | <0.001 |
| DOAC | 613 (22.2) | - | 612 (22.9) | 1 (1.2) | <0.001 |
| Reperfusion therapy | |||||
| Thrombolysis | 107 (3.9) | - | 98 (3.7) | 9 (11.0) | <0.001 |
| Surgical embolectomy | 13 (0.5) | - | 7 (0.3) | 6 (7.3) | <0.001 |
| ECMO | 17 (0.6) | - | 9 (0.3) | 8 (9.8) | <0.001 |
| Inferior vena cava filter | 9 (0.3) | - | 7 (0.3) | 2 (2.4) | <0.001 |
BMI: body mass index; VTE: venous thromboembolism; DVT: deep vein thrombosis; HR: heart rate; b.p.m: beat per minute; SBP: systolic blood pressure; Sa: oxygen saturation; eGRFCKD-EPI: estimated glomerular function by using the Chronic Kidney Disease Epidemiology Collaboration equation; RV: right ventricle; sPESI: simplified Pulmonary Embolism Severity Index; UFH: unfractionated heparin; LMWH: low molecular weight heparin; DOAC: direct oral anticoagulant; ECMO: extra-corporeal membrane oxygenation. a Active or anti-tumor therapy within the last 6 months, or metastatic state according to the 2019 European Society of Cardiology guidelines. b Within the past 4 weeks. c Antiplatelet therapy, non-steroidal anti-inflammatory drug. VTE-BLEED score: Venous Thrombo-Embolism Bleed; RIETE: Registro informatizado de la enfermedad tromboembólica en España; Computerized Registry of Patients with Venous Thromboembolism; ORBIT: Outcomes Registry for Better Informed Treatment; HAEMORR2HAGES score: Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke; ATRIA score: Anticoagulation and Risk Factors in Atrial Fibrillation; HAS-BLED score: Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol; ESC-defined risk PE category: pulmonary embolism risk category according to the guidelines of the European Society of Cardiology.