Medical history by study, treatment, and thrombophilia status
| . | Acute VTE treatment study (DIVERSITY) . | Secondary VTE prevention study . | ||||||
|---|---|---|---|---|---|---|---|---|
| Thrombophilia negative/unknown . | Thrombophilia documented . | Thrombophilia negative/unknown . | Thrombophilia documented . | |||||
| Dabigatran (N = 138) . | SOC (N = 67) . | Total (N = 205) . | Dabigatran (N = 39) . | SOC (N = 23) . | Total (N = 62) . | Total (N = 107) . | Total (N = 106) . | |
| Patients with medical history collected, n (%) | 137 (100) | 67 (100) | 204 (100) | 39 (100) | 23 (100) | 62 (100) | 106 (100) | 104 (100) |
| History of previous VTE other than index VTE, n (%) | 9 (6.6) | 7 (10.4) | 16 (7.8) | 5 (12.8) | 7 (30.4) | 12 (19.4) | 21 (19.8) | 18 (17.3) |
| 1 confirmed previous VTE | 8 (5.8) | 6 (9.0) | 14 (6.9) | 5 (12.8) | 6 (26.1) | 11 (17.7) | 6 (5.7) | 5 (4.8) |
| 2 confirmed previous VTEs | 1 (0.7) | 1 (1.5) | 2 (1.0) | 0 | 1 (4.3) | 1 (1.6) | 10 (9.4) | 10 (9.6) |
| ≥3 confirmed previous VTEs | 0 | 0 | 0 | 0 | 0 | 0 | 5 (4.7) | 3 (2.9) |
| Previous VTE unprovoked∗ | 7 (5.1) | 2 (3.0) | 9 (4.4) | 3 (7.7) | 3 (13.0) | 6 (9.7) | 14 (13.2) | 13 (12.5) |
| Previous VTE provoked∗ | 2 (1.5) | 5 (7.5) | 7 (3.4) | 2 (5.1) | 4 (17.4) | 6 (9.7) | 9 (8.5) | 5 (4.8) |
| PTS, n (%) | NA | NA | NA | NA | NA | NA | 12 (11.3)† | 24 (23.1) |
| Other medical history, n (%) | ||||||||
| Solid organ cancer | 8 (5.8) | 0 | 8 (3.9) | 0 | 0 | 0 | 4 (3.8) | 0 |
| Hematologic cancer | 10 (7.3) | 2 (3.0) | 12 (5.9) | 0 | 0 | 0 | 11 (10.4) | 1 (1.0) |
| Congenital heart disease | 20 (14.6) | 26 (38.8) | 46 (22.5) | 1 (2.6) | 1 (4.3) | 2 (3.2) | 14 (13.2) | 3 (2.9) |
| Hypertension | 1 (0.7) | 1 (1.5) | 2 (1.0) | 0 | 0 | 0 | 2 (1.9) | 1 (1.0) |
| Diabetes mellitus | 3 (2.2) | 1 (1.5) | 4 (2.0) | 1 (2.6) | 0 | 1 (1.6) | 0 | 0 |
| Heart failure | 6 (4.4) | 16 (23.9) | 22 (10.8) | 0 | 0 | 0 | 5 (4.7) | 0 |
| Stroke or transient ischemic attack | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.0) |
| Liver disease (currently not active) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.9) | 0 |
| Major or clinically relevant bleeding event | 1 (0.7) | 0 | 1 (0.5) | 0 | 0 | 0 | 0 | 1 (1.0) |
| Medical circumstances that increase risk of thrombosis, n (%) | ||||||||
| Recent immobilization‡ | 16 (11.7) | 6 (9.0) | 22 (10.8) | 6 (15.4) | 3 (13.0) | 9 (14.5) | 7 (6.6) | 1 (1.0) |
| Presence of central venous line/catheter | 37 (27.0) | 23 (34.3) | 60 (29.4) | 3 (7.7) | 1 (4.3) | 4 (6.5) | 11 (10.4) | 0 |
| Presence of other venous/arterial catheter | 9 (6.6) | 2 (3.0) | 11 (5.4) | 1 (2.6) | 0 | 1 (1.6) | 3 (2.8) | 1 (1.0) |
| Total parenteral nutrition dependency | 1 (0.7) | 0 | 1 (0.5) | 0 | 0 | 0 | 1 (0.9) | 0 |
| Other medical circumstances that increase risk of thrombosis§ | 25 (18.2) | 22 (32.8) | 47 (23.0) | 14 (35.9) | 2 (8.7) | 16 (25.8) | NA | NA |
| Other conditions requiring secondary VTE prophylaxis | ||||||||
| Recurrent unprovoked VTE | NA | NA | NA | NA | NA | NA | 24 (22.4) | 6 (5.7) |
| Structural venous abnormality‖ | 12 (8.8) | 7 (10.4) | 19 (9.3) | 2 (5.1) | 2 (8.7) | 4 (6.5) | 19 (17.8) | 10 (9.4) |
| Other¶ | NA | NA | NA | NA | NA | NA | 71 (66.4) | 32 (30.2) |
| . | Acute VTE treatment study (DIVERSITY) . | Secondary VTE prevention study . | ||||||
|---|---|---|---|---|---|---|---|---|
| Thrombophilia negative/unknown . | Thrombophilia documented . | Thrombophilia negative/unknown . | Thrombophilia documented . | |||||
| Dabigatran (N = 138) . | SOC (N = 67) . | Total (N = 205) . | Dabigatran (N = 39) . | SOC (N = 23) . | Total (N = 62) . | Total (N = 107) . | Total (N = 106) . | |
| Patients with medical history collected, n (%) | 137 (100) | 67 (100) | 204 (100) | 39 (100) | 23 (100) | 62 (100) | 106 (100) | 104 (100) |
| History of previous VTE other than index VTE, n (%) | 9 (6.6) | 7 (10.4) | 16 (7.8) | 5 (12.8) | 7 (30.4) | 12 (19.4) | 21 (19.8) | 18 (17.3) |
| 1 confirmed previous VTE | 8 (5.8) | 6 (9.0) | 14 (6.9) | 5 (12.8) | 6 (26.1) | 11 (17.7) | 6 (5.7) | 5 (4.8) |
| 2 confirmed previous VTEs | 1 (0.7) | 1 (1.5) | 2 (1.0) | 0 | 1 (4.3) | 1 (1.6) | 10 (9.4) | 10 (9.6) |
| ≥3 confirmed previous VTEs | 0 | 0 | 0 | 0 | 0 | 0 | 5 (4.7) | 3 (2.9) |
| Previous VTE unprovoked∗ | 7 (5.1) | 2 (3.0) | 9 (4.4) | 3 (7.7) | 3 (13.0) | 6 (9.7) | 14 (13.2) | 13 (12.5) |
| Previous VTE provoked∗ | 2 (1.5) | 5 (7.5) | 7 (3.4) | 2 (5.1) | 4 (17.4) | 6 (9.7) | 9 (8.5) | 5 (4.8) |
| PTS, n (%) | NA | NA | NA | NA | NA | NA | 12 (11.3)† | 24 (23.1) |
| Other medical history, n (%) | ||||||||
| Solid organ cancer | 8 (5.8) | 0 | 8 (3.9) | 0 | 0 | 0 | 4 (3.8) | 0 |
| Hematologic cancer | 10 (7.3) | 2 (3.0) | 12 (5.9) | 0 | 0 | 0 | 11 (10.4) | 1 (1.0) |
| Congenital heart disease | 20 (14.6) | 26 (38.8) | 46 (22.5) | 1 (2.6) | 1 (4.3) | 2 (3.2) | 14 (13.2) | 3 (2.9) |
| Hypertension | 1 (0.7) | 1 (1.5) | 2 (1.0) | 0 | 0 | 0 | 2 (1.9) | 1 (1.0) |
| Diabetes mellitus | 3 (2.2) | 1 (1.5) | 4 (2.0) | 1 (2.6) | 0 | 1 (1.6) | 0 | 0 |
| Heart failure | 6 (4.4) | 16 (23.9) | 22 (10.8) | 0 | 0 | 0 | 5 (4.7) | 0 |
| Stroke or transient ischemic attack | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.0) |
| Liver disease (currently not active) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0.9) | 0 |
| Major or clinically relevant bleeding event | 1 (0.7) | 0 | 1 (0.5) | 0 | 0 | 0 | 0 | 1 (1.0) |
| Medical circumstances that increase risk of thrombosis, n (%) | ||||||||
| Recent immobilization‡ | 16 (11.7) | 6 (9.0) | 22 (10.8) | 6 (15.4) | 3 (13.0) | 9 (14.5) | 7 (6.6) | 1 (1.0) |
| Presence of central venous line/catheter | 37 (27.0) | 23 (34.3) | 60 (29.4) | 3 (7.7) | 1 (4.3) | 4 (6.5) | 11 (10.4) | 0 |
| Presence of other venous/arterial catheter | 9 (6.6) | 2 (3.0) | 11 (5.4) | 1 (2.6) | 0 | 1 (1.6) | 3 (2.8) | 1 (1.0) |
| Total parenteral nutrition dependency | 1 (0.7) | 0 | 1 (0.5) | 0 | 0 | 0 | 1 (0.9) | 0 |
| Other medical circumstances that increase risk of thrombosis§ | 25 (18.2) | 22 (32.8) | 47 (23.0) | 14 (35.9) | 2 (8.7) | 16 (25.8) | NA | NA |
| Other conditions requiring secondary VTE prophylaxis | ||||||||
| Recurrent unprovoked VTE | NA | NA | NA | NA | NA | NA | 24 (22.4) | 6 (5.7) |
| Structural venous abnormality‖ | 12 (8.8) | 7 (10.4) | 19 (9.3) | 2 (5.1) | 2 (8.7) | 4 (6.5) | 19 (17.8) | 10 (9.4) |
| Other¶ | NA | NA | NA | NA | NA | NA | 71 (66.4) | 32 (30.2) |
Patients may be counted in >1 category.
One missing value.
Illness requiring bed rest, or paralysis.
Other medical circumstances that increase risk of thrombosis include congenital heart disease (both operated and not operated), cancer, and systemic inflammatory conditions (eg, systemic lupus erythematosus, inflammatory bowel disease).
Structural venous abnormalities may have been thoracic outlet syndrome, inferior vena cava atresia, May-Thurner syndrome; Klippel-Trenaunay syndrome; or CLOVES (congenital lipomatous overgrowth, vascular malformations, epidermal nevis, spinal/skeletal anomalies/scoliosis) syndrome or arteriovenous/venous malformation.
“Other conditions requiring secondary VTE prophylaxis” includes a variety of medical conditions with unclear thrombophilic significance considered to be conditions requiring secondary VTE prophylaxis in accordance with local VTE treatment/prophylactic protocols and comprise residual/unresolved DVT or sinus vein thrombosis, recurrent provoked VTE, strong family history of PE, and implantable medical devices other than central venous or arterial catheters (eg, ports, esndocardial electrodes). Most of these are conditions requiring secondary VTE prophylaxis only in combination with categories or VTE risk factors listed in other rubrics of the table, that is, medical circumstances that increase risk of thrombosis or thrombophilic conditions.