Baseline patient characteristics and treatments
| Characteristic/treatment . | All patients (N = 981) . | No bleeding (N = 756) . | Major bleeding (N = 100) . | Clinically relevant nonmajor bleeding (N = 125) . |
|---|---|---|---|---|
| n (%) or median (interquartile range)∗ . | ||||
| Age, y | 75 (69; 81) | 74 (69; 80) | 77 (70; 81) | 78 (71; 84) |
| Male sex | 524 (53) | 405 (54) | 51 (51) | 68 (54) |
| Localization of index VTE | ||||
| PE ± DVT | 682 (70) | 508 (67) | 77 (77) | 97 (78) |
| DVT only | 299 (30) | 248 (33) | 23 (23) | 28 (22) |
| Type of index VTE | ||||
| Provoked | 212 (22) | 160 (21) | 20 (20) | 32 (26) |
| Unprovoked† | 594 (61) | 466 (62) | 54 (54) | 74 (59) |
| Active cancer-related‡ | 175 (18) | 130 (17) | 26 (26) | 19 (15) |
| Arterial hypertension | 631 (64) | 483 (64) | 65 (65) | 83 (66) |
| Cardiac disease§ | 240 (24) | 167 (22) | 36 (36) | 37 (30) |
| Cerebrovascular disease‖ | 91 (9) | 65 (9) | 10 (10) | 16 (13) |
| Diabetes mellitus | 152 (15) | 114 (15) | 13 (13) | 25 (20) |
| Chronic renal disease¶ | 184 (19) | 133 (18) | 26 (26) | 25 (20) |
| Chronic liver disease# | 14 (1) | 10 (1) | 3 (3) | 1 (1) |
| History of major bleeding∗∗ | 95 (10) | 67 (9) | 11 (11) | 17 (14) |
| Recent surgery†† | 148 (15) | 113 (15) | 20 (20) | 15 (12) |
| Low physical activity‡‡ | 360 (37) | 251 (33) | 53 (53) | 56 (45) |
| High risk of fallsa | 450 (46) | 316 (42) | 54 (54) | 80 (64) |
| Anemiab | 382 (39) | 280 (37) | 53 (53) | 49 (39) |
| Thrombocytopeniac | 139 (14) | 102 (13) | 13 (13) | 24 (19) |
| Antiplatelet/NSAID therapyd | 377 (38) | 266 (35) | 49 (49) | 62 (50) |
| AC prior to index VTE | 51 (5) | 36 (5) | 7 (7) | 8 (6) |
| Initial parenteral AC | ||||
| LMWH | 465 (47) | 364 (48) | 40 (40) | 61 (49) |
| Unfractionated heparin | 332 (34) | 247 (33) | 38 (38) | 47 (38) |
| Fondaparinux | 158 (16) | 126 (17) | 16 (16) | 16 (13) |
| Danaparoid | 1 (0) | 0 (0) | 1 (1) | 0 (0) |
| No parenteral AC | 25 (3) | 19 (3) | 5 (5) | 1 (1) |
| Initial VKA therapy | 861 (88) | 668 (88) | 81 (81) | 112 (90) |
| Thrombolysise | 30 (3) | 23 (3) | 4 (4) | 3 (2) |
| Inferior vena cava filter | 10 (1) | 8 (1) | 0 (0) | 2 (2) |
| Characteristic/treatment . | All patients (N = 981) . | No bleeding (N = 756) . | Major bleeding (N = 100) . | Clinically relevant nonmajor bleeding (N = 125) . |
|---|---|---|---|---|
| n (%) or median (interquartile range)∗ . | ||||
| Age, y | 75 (69; 81) | 74 (69; 80) | 77 (70; 81) | 78 (71; 84) |
| Male sex | 524 (53) | 405 (54) | 51 (51) | 68 (54) |
| Localization of index VTE | ||||
| PE ± DVT | 682 (70) | 508 (67) | 77 (77) | 97 (78) |
| DVT only | 299 (30) | 248 (33) | 23 (23) | 28 (22) |
| Type of index VTE | ||||
| Provoked | 212 (22) | 160 (21) | 20 (20) | 32 (26) |
| Unprovoked† | 594 (61) | 466 (62) | 54 (54) | 74 (59) |
| Active cancer-related‡ | 175 (18) | 130 (17) | 26 (26) | 19 (15) |
| Arterial hypertension | 631 (64) | 483 (64) | 65 (65) | 83 (66) |
| Cardiac disease§ | 240 (24) | 167 (22) | 36 (36) | 37 (30) |
| Cerebrovascular disease‖ | 91 (9) | 65 (9) | 10 (10) | 16 (13) |
| Diabetes mellitus | 152 (15) | 114 (15) | 13 (13) | 25 (20) |
| Chronic renal disease¶ | 184 (19) | 133 (18) | 26 (26) | 25 (20) |
| Chronic liver disease# | 14 (1) | 10 (1) | 3 (3) | 1 (1) |
| History of major bleeding∗∗ | 95 (10) | 67 (9) | 11 (11) | 17 (14) |
| Recent surgery†† | 148 (15) | 113 (15) | 20 (20) | 15 (12) |
| Low physical activity‡‡ | 360 (37) | 251 (33) | 53 (53) | 56 (45) |
| High risk of fallsa | 450 (46) | 316 (42) | 54 (54) | 80 (64) |
| Anemiab | 382 (39) | 280 (37) | 53 (53) | 49 (39) |
| Thrombocytopeniac | 139 (14) | 102 (13) | 13 (13) | 24 (19) |
| Antiplatelet/NSAID therapyd | 377 (38) | 266 (35) | 49 (49) | 62 (50) |
| AC prior to index VTE | 51 (5) | 36 (5) | 7 (7) | 8 (6) |
| Initial parenteral AC | ||||
| LMWH | 465 (47) | 364 (48) | 40 (40) | 61 (49) |
| Unfractionated heparin | 332 (34) | 247 (33) | 38 (38) | 47 (38) |
| Fondaparinux | 158 (16) | 126 (17) | 16 (16) | 16 (13) |
| Danaparoid | 1 (0) | 0 (0) | 1 (1) | 0 (0) |
| No parenteral AC | 25 (3) | 19 (3) | 5 (5) | 1 (1) |
| Initial VKA therapy | 861 (88) | 668 (88) | 81 (81) | 112 (90) |
| Thrombolysise | 30 (3) | 23 (3) | 4 (4) | 3 (2) |
| Inferior vena cava filter | 10 (1) | 8 (1) | 0 (0) | 2 (2) |
AC, anticoagulant; DVT, deep vein thrombosis; LMWH, low-molecular-weight heparin; NSAID, nonsteroidal antiinflammatory drug; PE, pulmonary embolism.
Patients with both major and clinically relevant nonmajor bleeding are shown in the major bleeding category.
Values were missing for history of major bleeding (0.1%), low physical activity (0.3%), high risk of falls 0.2%), anemia (6.3%), and thrombocytopenia (6.3%).
Absence of major surgery, estrogen therapy, immobilization, or active cancer during the last 3 months before the index VTE.
VTE in a patient with solid or hematologic cancer requiring chemotherapy, radiotherapy, surgery, or palliative care during last 3 months.
Systolic or diastolic heart failure, left or right heart failure, forward or backward heart failure, left ventricular ejection fraction <40%, acute heart failure during the last 3 months, a myocardial infarction with or without ST elevation during the last 3 months, or history of coronary heart disease.
Ischemic or hemorrhagic stroke with hemiparesis, hemiplegia, or paraplegia.
Diabetic or hypertensive nephropathy, chronic glomerulonephritis or interstitial nephritis, myeloma-related nephropathy, or cystic kidney disease.
Liver cirrhosis, chronic hepatitis, chronic liver failure, or hemochromatosis.
Any bleeding that led to a hospital stay or transfusions.
Surgery requiring general or spinal anesthesia during the last 3 months.
Mostly lying/sitting activity or avoidance to climb stairs/carry light weight.
Self-reported fall during the previous year or any problem with gait, balance, or mobility.
Serum hemoglobin <13 g/dL in men or <12 g/dL in women.
Platelet count <150 g/L.
Aspirin, clopidogrel, prasugrel, aspirin/dipyridamole, or nonsteroidal antiinflammatory drugs.
Catheter-directed or systemic thrombolysis.