Details of thrombophilia conditions 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) . | |
| Thrombophilia conditions, n (%)∗ | ||||||||
| FVL | 0 | 0 | 0 | 18 (46.2) | 8 (34.8) | 26 (41.9) | 0 | 35 (33.0) |
| PT mutation | 0 | 0 | 0 | 9 (23.1) | 3 (13.0) | 12 (19.4) | 0 | 18 (17.0) |
| Antithrombin deficiency | 0 | 0 | 0 | 6 (15.4) | 3 (13.0) | 9 (14.5) | 0 | 21 (19.8) |
| Protein C/S deficiency | 0 | 0 | 0 | 7 (17.9) | 7 (30.4) | 14 (22.6) | 0 | 26 (24.5) |
| APLA/LA | 0 | 0 | 0 | 4 (10.3) | 7 (30.4) | 11 (17.7) | 0 | 21 (19.8) |
| Thrombophilia conditions in detail, n (%) | ||||||||
| Major thrombophilia∗ | 0 | 0 | 0 | 20 (51.3) | 17 (73.9) | 37 (59.7) | 0 | 73 (68.9) |
| FVL (homozygous) | 0 | 0 | 0 | 1 (5.0) | 0 | 1 (2.7) | 0 | 5 (6.8) |
| PT mutation (homozygous) | 0 | 0 | 0 | 1 (5.0) | 0 | 1 (2.7) | 0 | 4 (5.5) |
| FVL (heterozygous) + PT mutations (heterozygous) | 0 | 0 | 0 | 3 (15.0) | 2 (11.8) | 5 (13.5) | 0 | 6 (8.2) |
| Protein C/S deficiency | 0 | 0 | 0 | 7 (35.0) | 7 (41.2) | 14 (37.8) | 0 | 26 (35.6) |
| Antithrombin deficiency | 0 | 0 | 0 | 6 (30.0) | 3 (17.6) | 99 (24.3) | 0 | 21 (28.8) |
| APLA and/or LA | 0 | 0 | 0 | 4 (20.0) | 7 (41.2) | 11 (29.7) | 0 | 21 (28.8) |
| Combined† (including other mutations and conditions‡) | 0 | 0 | 0 | 4 (20.0) | 2 (11.8) | 6 (16.2) | 0 | 11 (15.1) |
| Minor thrombophilia∗ | 0 | 0 | 0 | 19 (48.7) | 6 (4.3) | 25 (40.3) | 0 | 33 (31.1) |
| FVL (heterozygous) | 0 | 0 | 0 | 11 (57.9) | 5 (83.3) | 16 (64.0) | 0 | 15 (45.5) |
| PT mutation (heterozygous or unknown) | 0 | 0 | 0 | 3 (15.8) | 1 (16.7) | 4 (16.0) | 0 | 5 (15.2) |
| Other mutations and conditions‡ with unclear thrombophilic significance | 0 | 0 | 0 | 5 (26.3) | 1 (16.7) | 6 (24.0) | 0 | 13 (39.4) |
| MTHFR mutation | 0 | 0 | 0 | 4 (21.1) | 1 (16.7) | 5 (20.0) | 0 | 11 (33.3) |
| PAI-1 mutation | 0 | 0 | 0 | 2 (10.5) | 0 | 2 (8.0) | 0 | 3 (9.1) |
| FGB mutation | 0 | 0 | 0 | 3 (15.8) | 0 | 3 (12.0) | 0 | 2 (6.1) |
| ACE mutation | 0 | 0 | 0 | 1 (5.3) | 0 | 1 (4.0) | 0 | 0 |
| MTR mutation | 0 | 0 | 0 | 1 (5.3) | 0 | 1 (4.0) | 0 | 0 |
| GPIA/GPIIIA | 0 | 0 | 0 | 1 (5.3) | 0 | 1 (4.0) | 0 | 1 (3.0) |
| Dyslipidemia | 0 | 0 | 0 | 1 (5.3) | 0 | 1 (4.0) | 0 | 0 |
| Thrombocytopathy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.0) |
| Fibrinolysis enzyme activity abnormality | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.0) |
| Combined‡ | 0 | 0 | 0 | 5 (26.3) | 1 (16.7) | 6 (24.0) | 0 | 13 (39.4) |
| . | 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) . | |
| Thrombophilia conditions, n (%)∗ | ||||||||
| FVL | 0 | 0 | 0 | 18 (46.2) | 8 (34.8) | 26 (41.9) | 0 | 35 (33.0) |
| PT mutation | 0 | 0 | 0 | 9 (23.1) | 3 (13.0) | 12 (19.4) | 0 | 18 (17.0) |
| Antithrombin deficiency | 0 | 0 | 0 | 6 (15.4) | 3 (13.0) | 9 (14.5) | 0 | 21 (19.8) |
| Protein C/S deficiency | 0 | 0 | 0 | 7 (17.9) | 7 (30.4) | 14 (22.6) | 0 | 26 (24.5) |
| APLA/LA | 0 | 0 | 0 | 4 (10.3) | 7 (30.4) | 11 (17.7) | 0 | 21 (19.8) |
| Thrombophilia conditions in detail, n (%) | ||||||||
| Major thrombophilia∗ | 0 | 0 | 0 | 20 (51.3) | 17 (73.9) | 37 (59.7) | 0 | 73 (68.9) |
| FVL (homozygous) | 0 | 0 | 0 | 1 (5.0) | 0 | 1 (2.7) | 0 | 5 (6.8) |
| PT mutation (homozygous) | 0 | 0 | 0 | 1 (5.0) | 0 | 1 (2.7) | 0 | 4 (5.5) |
| FVL (heterozygous) + PT mutations (heterozygous) | 0 | 0 | 0 | 3 (15.0) | 2 (11.8) | 5 (13.5) | 0 | 6 (8.2) |
| Protein C/S deficiency | 0 | 0 | 0 | 7 (35.0) | 7 (41.2) | 14 (37.8) | 0 | 26 (35.6) |
| Antithrombin deficiency | 0 | 0 | 0 | 6 (30.0) | 3 (17.6) | 99 (24.3) | 0 | 21 (28.8) |
| APLA and/or LA | 0 | 0 | 0 | 4 (20.0) | 7 (41.2) | 11 (29.7) | 0 | 21 (28.8) |
| Combined† (including other mutations and conditions‡) | 0 | 0 | 0 | 4 (20.0) | 2 (11.8) | 6 (16.2) | 0 | 11 (15.1) |
| Minor thrombophilia∗ | 0 | 0 | 0 | 19 (48.7) | 6 (4.3) | 25 (40.3) | 0 | 33 (31.1) |
| FVL (heterozygous) | 0 | 0 | 0 | 11 (57.9) | 5 (83.3) | 16 (64.0) | 0 | 15 (45.5) |
| PT mutation (heterozygous or unknown) | 0 | 0 | 0 | 3 (15.8) | 1 (16.7) | 4 (16.0) | 0 | 5 (15.2) |
| Other mutations and conditions‡ with unclear thrombophilic significance | 0 | 0 | 0 | 5 (26.3) | 1 (16.7) | 6 (24.0) | 0 | 13 (39.4) |
| MTHFR mutation | 0 | 0 | 0 | 4 (21.1) | 1 (16.7) | 5 (20.0) | 0 | 11 (33.3) |
| PAI-1 mutation | 0 | 0 | 0 | 2 (10.5) | 0 | 2 (8.0) | 0 | 3 (9.1) |
| FGB mutation | 0 | 0 | 0 | 3 (15.8) | 0 | 3 (12.0) | 0 | 2 (6.1) |
| ACE mutation | 0 | 0 | 0 | 1 (5.3) | 0 | 1 (4.0) | 0 | 0 |
| MTR mutation | 0 | 0 | 0 | 1 (5.3) | 0 | 1 (4.0) | 0 | 0 |
| GPIA/GPIIIA | 0 | 0 | 0 | 1 (5.3) | 0 | 1 (4.0) | 0 | 1 (3.0) |
| Dyslipidemia | 0 | 0 | 0 | 1 (5.3) | 0 | 1 (4.0) | 0 | 0 |
| Thrombocytopathy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.0) |
| Fibrinolysis enzyme activity abnormality | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.0) |
| Combined‡ | 0 | 0 | 0 | 5 (26.3) | 1 (16.7) | 6 (24.0) | 0 | 13 (39.4) |
ACE, angiotensin I-converting enzyme; FGB, fibrinogen β chain; GPIA, glycoprotein Ia; GPIIIA, glycoprotein IIIa; MTHFR, methylenetetrahydrofolate reductase; MTR, methionine synthase reductase; PAI-1, plasminogen activator inhibitor 1.
Patients may be counted in >1 category.
For acute VTE treatment study, combined for “major thrombophilia”: APLA/LA + other mutations and conditions, MTHFR (n = 1); APLA/LA + other mutations and conditions, PAI-1, MTHFR, MTR (n = 1); antithrombin deficiency + other mutations and conditions, MTHFR (n = 1); antithrombin deficiency + PT mutation (heterozygous) + other mutations and conditions, PAI-1, thrombospondins, ACE (n = 1); protein C/S deficiency + other mutations and condition, PAI-1 (n = 1); protein C/S deficiency + PT mutation (heterozygous) + other mutations and conditions, MTHFR, FGB, PAI-1 (n = 1). Combined “minor thrombophilia”: FVL (heterozygous) + other mutations and conditions, MTHFR (n = 1); other mutations and conditions, dyslipidemia (n = 1); other mutations and conditions, FGB, MTHFR, PAI-1, GPIA, GPIIIA, ACE (n = 1); other mutations and conditions, FGB, PAI-1, MTHFR (n = 1); other mutations and conditions, FGB, MTHFR, MTR (n = 1); other mutations and conditions, MTHFR (n = 1). For secondary VTE prevention study, combined for “major thrombophilia”: APLA/LA + other mutations and conditions, MTHFR (n = 1); APLA//LA + other mutations and conditions, MTHFR, integrin A2 pathology (n = 1); APLA/LA + other mutations and conditions, PAI-1, GPIA, GPIIIA (n = 1); antithrombin deficiency + other mutations and conditions, factor XII deficiency (n = 1); antithrombin deficiency + other mutations and conditions, MTHFR (n = 2); FVL (heterozygous) + PT mutation (heterozygous) + other mutations and conditions, MTHFR (n = 1); FVL (homozygous) + other mutations and conditions, MTHFR (n = 1); protein C/S deficiency + other mutations and conditions, MTHFR (n = 2); protein C/S deficiency + other mutations and conditions, sustained elevated factor VIII level (n = 1). Combined for “minor thrombophilia”: FVL (heterozygous) + other mutations and conditions, MTHFR (n = 1); FVL (heterozygous) + other mutations and conditions, thrombocytopathy (n = 1); other mutations and conditions, FGB + GPIA (n = 1); other mutations and conditions, MTHFR (n = 7); other mutations and conditions, MTHFR + PAI 4G polymorphism + FGB (n = 1); other mutations and conditions, MTHFR + PAI 4G/5G polymorphism (n = 1); other mutations and conditions, MTHFR + PAI-1 + fibrinolysis enzyme activity abnormality (n = 1).
Other mutations and conditions with indefinite thrombophilic significance: MTHFR, PAI-1, sustained elevated factor VIII level, factor XII deficiency, ACE mutation,53 thrombospondin mutations, MTR mutation,54 GPIA, GPIIIA, integrin A2 pathology, thrombocytopathy, FGB mutation, and fibrinolysis enzyme activity abnormality.