VTE-related outcomes during anticoagulation and after its discontinuation, according to IT testing, and patient groups of interest
| Patient Population . | Thrombophilia Status . | Number of Patients . | Duration of AC Therapy (Months) Median, IQR . | Recurrent VTE on AC (Events/100 PY) . | Recurrent VTE after AC Discontinuation (Events/100 PY) . | Major Bleeding Events (Events/100 PY) . | Mortality (Events/100 PY) . | VTE-related mortality (Events/100 PY) . | Bleeding-related mortality (Events/100 PY) . | Cancer-related mortality (Events/100 PY) . | Notes . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Patients with VTE provoked by recent surgery | Patients not tested for IT | 9018 | 4.70 (3.15-7.69) | 3.18 (2.73-3.67) | 5.46 (4.78-6.20) | 3.58 (3.22-3.97) | 10.8 (10.2-11.5) | 0.62 (0.48-0.79) | 0.46 (0.34-0.61) | 4.22 (3.83-4.63) | |
| Tested patients (all) | 2075 | 6.41 (4.01-11.0)∗ | 3.72 (2.92-4.69) | 4.63 (3.78-5.62) | 1.21 (0.91-1.58)∗ | 1.79 (1.42-2.22)∗ | 0.07 (0.02-0.19)∗ | 0.07 (0.02-0.19)∗ | 0.93 (0.67-1.25)∗ | ||
| Negative thrombophilia | 1314 | 6.23 (3.91-9.63)∗ | 3.91 (2.82-5.29) | 3.42 (2.57-4.48)† | 1.28 (0.90-1.78)∗ | 1.64 (1.20-2.18)∗ | 0.04 (0.00-0.19)∗ | 0.08 (0.01-0.25)† | 0.84 (0.54-1.25)∗ | ||
| All positive thrombophilia | 761 | 7.00 (4.21-12.6)∗ | 3.51 (2.41-4.95) | 7.25 (5.42-9.50) | 1.10 (0.67-1.70)∗ | 2.03 (1.43-2.80)∗ | 0.12 (0.02-0.39)† | 0.06 (0.00-0.29)† | 1.07 (0.66-1.66)∗ | ||
| Patients with VTE provoked by immobilization ≥4 d | Patients not tested for IT | 19 199 | 4.47 (3.02-7.59) | 3.57 (3.24-3.94) | 8.38 (7.65-9.16) | 5.31 (4.98-5.67) | 25.3 (24.5-26.0) | 1.98 (1.78-2.19) | 1.15 (1.00-1.32) | 5.95 (5.60-6.32) | |
| Tested patients (all) | 3762 | 6.14 (3.61-11.1)∗ | 2.67 (2.15-3.29)‡ | 6.36 (5.48-7.35)† | 1.52 (1.24-1.85)∗ | 3.65 (3.21-4.14)∗ | 0.16 (0.08-0.28)∗ | 0.19 (0.10-0.32)∗ | 0.90 (0.69-1.16)∗ | ||
| Negative thrombophilia | 2449 | 5.82 (3.52-9.03)∗ | 2.26 (1.64-3.03)† | 6.09 (5.06-7.27)† | 1.54 (1.19-1.97)∗ | 3.53 (2.98-4.15)∗ | 0.13 (0.05-0.28)∗ | 0.15 (0.06-0.31)∗ | 0.85 (0.60-1.17)∗ | ||
| All positive thrombophilia | 1313 | 7.03 (4.09-13.4)∗ | 3.25 (2.38-4.33) | 6.95 (5.38-8.83) | 1.48 (1.05-2.04)∗ | 3.86 (3.13-4.70)∗ | 0.21 (0.08-0.46)∗ | 0.25 (0.10-0.52)∗ | 1.00 (0.65-1.46)∗ | ||
| Patients with VTE provoked by estrogen use | Patients not tested for IT | 3466 | 5.22 (3.22-8.54) | 2.55 (1.96-3.26) | 4.61 (3.60-5.83) | 2.12 (1.70-2.62) | 8.89 (7.99-9.86) | 0.46 (0.28-0.71) | 0.31 (0.17-0.52) | 4.25 (3.65-4.94) | |
| Tested patients (all) | 2365 | 6.54 (4.17-11.3)∗ | 1.56 (1.08-2.17)‡ | 2.35 (1.80-3.03)∗ | 0.59 (0.40-0.84)∗ | 0.58 (0.39-0.84)∗ | 0.04 (0.01-0.14)∗ | - | 0.32 (0.19-0.52)∗ | ||
| Negative thrombophilia | 1448 | 6.37 (4.01-9.76)∗ | 1.36 (0.79-2.20)‡ | 2.31 (1.63-3.17)∗ | 0.83 (0.53-1.23)∗ | 0.59 (0.35-0.94)∗ | 0.04 (0.00-0.18)∗ | - | 0.30 (0.14-0.56)∗ | ||
| All positive thrombophilia | 917 | 7.03 (4.57-12.4)∗ | 1.78 (1.07-2.79) | 2.43 (1.56-3.62)† | 0.26 (0.10-0.58)∗ | 0.57 (0.30-0.99)∗ | 0.05 (0.00-0.26)† | - | 0.36 (0.16-0.72)∗ | ||
| Patients with VTE provoked by pregnancy or postpartum | Patients not tested for IT | 676 | 4.67 (3.22-7.20) | 3.28 (1.72-5.70) | 2.53 (1.23-4.63) | 1.29 (0.63-2.38) | 0.99 (0.43-1.97) | 0.14 (0.01-0.70) | 0.14 (0.01-0.70) | 0.14 (0.01-0.70) | |
| Tested patients (all) | 608 | 6.47 (4.17-9.84)∗ | 3.02 (1.75-4.87) | 1.13 (0.55-2.07) | 0.53 (0.23-1.05) | 0.08 (0.00-0.37)† | - | - | 0.08 (0.00-0.37) | ||
| Negative thrombophilia | 313 | 6.34 (4.01-8.77)∗ | 2.95 (1.20-6.14) | 0.23 (0.01-1.11)† | 0.46 (0.12-1.26) | - | - | - | - | ||
| All positive thrombophilia | 295 | 6.64 (4.21-11.1)∗ | 3.07 (1.50-5.63) | 2.27 (1.05-4.31) | 0.60 (0.19-1.45) | 0.15 (0.01-0.73)‡ | - | - | 0.15 (0.01-0.73) | ||
| Unprovoked VTE | Patients not tested for IT | 40 190 | 6.11 (3.42-11.4) | 2.34 (2.18-2.51) | 9.73 (9.22-10.3) | 2.10 (1.97-2.23) | 5.82 (5.61-6.04) | 0.51 (0.45-0.57) | 0.36 (0.31-0.41) | 0.47 (0.41-0.54) | |
| Tested patients (all) | 11 945 | 8.10 (5.22-15.1)∗ | 2.24 (2.00-2.49) | 8.83 (8.22-9.48)‡ | 0.93 (0.81-1.06)∗ | 1.01 (0.90-1.15)∗ | 0.06 (0.03-0.09)∗ | 0.06 (0.04-0.10)∗ | 0.11 (0.08-0.16)∗ | ||
| Negative thrombophilia | 6959 | 7.59 (5.16-13.6)∗ | 2.19 (1.88-2.54) | 8.23 (7.49-9.02)† | 1.02 (0.86-1.20)∗ | 0.99 (0.83-1.16)∗ | 0.06 (0.03-0.11)∗ | 0.06 (0.03-0.11)∗ | 0.13 (0.08-0.20)∗ | ||
| All positive thrombophilia | 4986 | 9.05 (5.39-18.2)∗ | 2.29 (1.95-2.67) | 9.90 (8.83-11.07) | 0.81 (0.65-1.00)∗ | 1.05 (0.87-1.26)∗ | 0.06 (0.02-0.12)∗ | 0.07 (0.03-0.14)∗ | 0.09 (0.05-0.17)∗ | ||
| Patients with splanchnic vein thrombosis | Patients not tested for IT | 611 | 4.67 (2.92-9.33) | 3.26 (1.81-5.43) | 7.39 (4.11-12.32) | 7.85 (5.78-10.5) | 26.6 (22.7-31.0) | 0.17 (0.01-0.84) | 1.52 (0.74-2.80) | 14.7 (11.9-18.1) | |
| Tested patients (all) | 287 | 8.41 (3.75-20.4)∗ | 2.25 (1.10-4.12) | 1.00 (0.17-3.31)† | 1.48 (0.72-2.72)∗ | 1.13 (0.50-2.24)∗ | - | 0.16 (0.01-0.80)† | 0.32 (0.05-1.07)∗ | ||
| Negative thrombophilia | 171 | 6.18 (3.52-16.4)‡ | 2.66 (0.97-5.89) | 1.56 (0.26-5.16)‡ | 0.93 (0.24-2.52)∗ | 0.61 (0.10-2.01)∗ | - | - | 0.61 (0.10-2.01)∗ | ||
| All positive thrombophilia | 116 | 12.0 (4.11-28.8)∗ | 1.88 (0.60-4.54) | - | 2.12 (0.86-4.41)∗ | 1.73 (0.64-3.85)∗ | - | 0.35 (0.02-1.71) | - | ||
| Patients with cerebral sinus vein thrombosis | Patients not tested for IT | 162 | 5.22 (3.24-10.1) | 1.55 (0.26-5.11) | 2.56 (0.43-8.47) | 3.91 (1.82-7.42) | 8.62 (5.27-13.4) | 0.48 (0.02-2.36) | 0.96 (0.16-3.16) | 2.87 (1.16-5.97) | |
| Tested patients (all) | 130 | 9.00 (5.32-15.8)∗ | 1.12 (0.19-3.70) | 1.76 (0.30-5.82) | 1.37 (0.44-3.31) | 2.35 (1.03-4.65)† | - | 0.67 (0.11-2.22) | 1.68 (0.62-3.72) | ||
| Negative thrombophilia | 70 | 10.2 (4.58-15.9)† | 1.20 (0.06-5.94) | 3.06 (0.51-10.10) | 2.03 (0.52-5.51) | 2.60 (0.83-6.26)‡ | - | 0.65 (0.03-3.20) | 1.95 (0.50-5.30) | ||
| All positive thrombophilia | 60 | 8.18 (5.82-14.9)† | 1.05 (0.05-5.17) | - | 0.70 (0.03-3.43) | 2.09 (0.53-5.68)‡ | - | 0.70 (0.03-3.43) | 1.39 (0.23-4.59) |
| Patient Population . | Thrombophilia Status . | Number of Patients . | Duration of AC Therapy (Months) Median, IQR . | Recurrent VTE on AC (Events/100 PY) . | Recurrent VTE after AC Discontinuation (Events/100 PY) . | Major Bleeding Events (Events/100 PY) . | Mortality (Events/100 PY) . | VTE-related mortality (Events/100 PY) . | Bleeding-related mortality (Events/100 PY) . | Cancer-related mortality (Events/100 PY) . | Notes . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Patients with VTE provoked by recent surgery | Patients not tested for IT | 9018 | 4.70 (3.15-7.69) | 3.18 (2.73-3.67) | 5.46 (4.78-6.20) | 3.58 (3.22-3.97) | 10.8 (10.2-11.5) | 0.62 (0.48-0.79) | 0.46 (0.34-0.61) | 4.22 (3.83-4.63) | |
| Tested patients (all) | 2075 | 6.41 (4.01-11.0)∗ | 3.72 (2.92-4.69) | 4.63 (3.78-5.62) | 1.21 (0.91-1.58)∗ | 1.79 (1.42-2.22)∗ | 0.07 (0.02-0.19)∗ | 0.07 (0.02-0.19)∗ | 0.93 (0.67-1.25)∗ | ||
| Negative thrombophilia | 1314 | 6.23 (3.91-9.63)∗ | 3.91 (2.82-5.29) | 3.42 (2.57-4.48)† | 1.28 (0.90-1.78)∗ | 1.64 (1.20-2.18)∗ | 0.04 (0.00-0.19)∗ | 0.08 (0.01-0.25)† | 0.84 (0.54-1.25)∗ | ||
| All positive thrombophilia | 761 | 7.00 (4.21-12.6)∗ | 3.51 (2.41-4.95) | 7.25 (5.42-9.50) | 1.10 (0.67-1.70)∗ | 2.03 (1.43-2.80)∗ | 0.12 (0.02-0.39)† | 0.06 (0.00-0.29)† | 1.07 (0.66-1.66)∗ | ||
| Patients with VTE provoked by immobilization ≥4 d | Patients not tested for IT | 19 199 | 4.47 (3.02-7.59) | 3.57 (3.24-3.94) | 8.38 (7.65-9.16) | 5.31 (4.98-5.67) | 25.3 (24.5-26.0) | 1.98 (1.78-2.19) | 1.15 (1.00-1.32) | 5.95 (5.60-6.32) | |
| Tested patients (all) | 3762 | 6.14 (3.61-11.1)∗ | 2.67 (2.15-3.29)‡ | 6.36 (5.48-7.35)† | 1.52 (1.24-1.85)∗ | 3.65 (3.21-4.14)∗ | 0.16 (0.08-0.28)∗ | 0.19 (0.10-0.32)∗ | 0.90 (0.69-1.16)∗ | ||
| Negative thrombophilia | 2449 | 5.82 (3.52-9.03)∗ | 2.26 (1.64-3.03)† | 6.09 (5.06-7.27)† | 1.54 (1.19-1.97)∗ | 3.53 (2.98-4.15)∗ | 0.13 (0.05-0.28)∗ | 0.15 (0.06-0.31)∗ | 0.85 (0.60-1.17)∗ | ||
| All positive thrombophilia | 1313 | 7.03 (4.09-13.4)∗ | 3.25 (2.38-4.33) | 6.95 (5.38-8.83) | 1.48 (1.05-2.04)∗ | 3.86 (3.13-4.70)∗ | 0.21 (0.08-0.46)∗ | 0.25 (0.10-0.52)∗ | 1.00 (0.65-1.46)∗ | ||
| Patients with VTE provoked by estrogen use | Patients not tested for IT | 3466 | 5.22 (3.22-8.54) | 2.55 (1.96-3.26) | 4.61 (3.60-5.83) | 2.12 (1.70-2.62) | 8.89 (7.99-9.86) | 0.46 (0.28-0.71) | 0.31 (0.17-0.52) | 4.25 (3.65-4.94) | |
| Tested patients (all) | 2365 | 6.54 (4.17-11.3)∗ | 1.56 (1.08-2.17)‡ | 2.35 (1.80-3.03)∗ | 0.59 (0.40-0.84)∗ | 0.58 (0.39-0.84)∗ | 0.04 (0.01-0.14)∗ | - | 0.32 (0.19-0.52)∗ | ||
| Negative thrombophilia | 1448 | 6.37 (4.01-9.76)∗ | 1.36 (0.79-2.20)‡ | 2.31 (1.63-3.17)∗ | 0.83 (0.53-1.23)∗ | 0.59 (0.35-0.94)∗ | 0.04 (0.00-0.18)∗ | - | 0.30 (0.14-0.56)∗ | ||
| All positive thrombophilia | 917 | 7.03 (4.57-12.4)∗ | 1.78 (1.07-2.79) | 2.43 (1.56-3.62)† | 0.26 (0.10-0.58)∗ | 0.57 (0.30-0.99)∗ | 0.05 (0.00-0.26)† | - | 0.36 (0.16-0.72)∗ | ||
| Patients with VTE provoked by pregnancy or postpartum | Patients not tested for IT | 676 | 4.67 (3.22-7.20) | 3.28 (1.72-5.70) | 2.53 (1.23-4.63) | 1.29 (0.63-2.38) | 0.99 (0.43-1.97) | 0.14 (0.01-0.70) | 0.14 (0.01-0.70) | 0.14 (0.01-0.70) | |
| Tested patients (all) | 608 | 6.47 (4.17-9.84)∗ | 3.02 (1.75-4.87) | 1.13 (0.55-2.07) | 0.53 (0.23-1.05) | 0.08 (0.00-0.37)† | - | - | 0.08 (0.00-0.37) | ||
| Negative thrombophilia | 313 | 6.34 (4.01-8.77)∗ | 2.95 (1.20-6.14) | 0.23 (0.01-1.11)† | 0.46 (0.12-1.26) | - | - | - | - | ||
| All positive thrombophilia | 295 | 6.64 (4.21-11.1)∗ | 3.07 (1.50-5.63) | 2.27 (1.05-4.31) | 0.60 (0.19-1.45) | 0.15 (0.01-0.73)‡ | - | - | 0.15 (0.01-0.73) | ||
| Unprovoked VTE | Patients not tested for IT | 40 190 | 6.11 (3.42-11.4) | 2.34 (2.18-2.51) | 9.73 (9.22-10.3) | 2.10 (1.97-2.23) | 5.82 (5.61-6.04) | 0.51 (0.45-0.57) | 0.36 (0.31-0.41) | 0.47 (0.41-0.54) | |
| Tested patients (all) | 11 945 | 8.10 (5.22-15.1)∗ | 2.24 (2.00-2.49) | 8.83 (8.22-9.48)‡ | 0.93 (0.81-1.06)∗ | 1.01 (0.90-1.15)∗ | 0.06 (0.03-0.09)∗ | 0.06 (0.04-0.10)∗ | 0.11 (0.08-0.16)∗ | ||
| Negative thrombophilia | 6959 | 7.59 (5.16-13.6)∗ | 2.19 (1.88-2.54) | 8.23 (7.49-9.02)† | 1.02 (0.86-1.20)∗ | 0.99 (0.83-1.16)∗ | 0.06 (0.03-0.11)∗ | 0.06 (0.03-0.11)∗ | 0.13 (0.08-0.20)∗ | ||
| All positive thrombophilia | 4986 | 9.05 (5.39-18.2)∗ | 2.29 (1.95-2.67) | 9.90 (8.83-11.07) | 0.81 (0.65-1.00)∗ | 1.05 (0.87-1.26)∗ | 0.06 (0.02-0.12)∗ | 0.07 (0.03-0.14)∗ | 0.09 (0.05-0.17)∗ | ||
| Patients with splanchnic vein thrombosis | Patients not tested for IT | 611 | 4.67 (2.92-9.33) | 3.26 (1.81-5.43) | 7.39 (4.11-12.32) | 7.85 (5.78-10.5) | 26.6 (22.7-31.0) | 0.17 (0.01-0.84) | 1.52 (0.74-2.80) | 14.7 (11.9-18.1) | |
| Tested patients (all) | 287 | 8.41 (3.75-20.4)∗ | 2.25 (1.10-4.12) | 1.00 (0.17-3.31)† | 1.48 (0.72-2.72)∗ | 1.13 (0.50-2.24)∗ | - | 0.16 (0.01-0.80)† | 0.32 (0.05-1.07)∗ | ||
| Negative thrombophilia | 171 | 6.18 (3.52-16.4)‡ | 2.66 (0.97-5.89) | 1.56 (0.26-5.16)‡ | 0.93 (0.24-2.52)∗ | 0.61 (0.10-2.01)∗ | - | - | 0.61 (0.10-2.01)∗ | ||
| All positive thrombophilia | 116 | 12.0 (4.11-28.8)∗ | 1.88 (0.60-4.54) | - | 2.12 (0.86-4.41)∗ | 1.73 (0.64-3.85)∗ | - | 0.35 (0.02-1.71) | - | ||
| Patients with cerebral sinus vein thrombosis | Patients not tested for IT | 162 | 5.22 (3.24-10.1) | 1.55 (0.26-5.11) | 2.56 (0.43-8.47) | 3.91 (1.82-7.42) | 8.62 (5.27-13.4) | 0.48 (0.02-2.36) | 0.96 (0.16-3.16) | 2.87 (1.16-5.97) | |
| Tested patients (all) | 130 | 9.00 (5.32-15.8)∗ | 1.12 (0.19-3.70) | 1.76 (0.30-5.82) | 1.37 (0.44-3.31) | 2.35 (1.03-4.65)† | - | 0.67 (0.11-2.22) | 1.68 (0.62-3.72) | ||
| Negative thrombophilia | 70 | 10.2 (4.58-15.9)† | 1.20 (0.06-5.94) | 3.06 (0.51-10.10) | 2.03 (0.52-5.51) | 2.60 (0.83-6.26)‡ | - | 0.65 (0.03-3.20) | 1.95 (0.50-5.30) | ||
| All positive thrombophilia | 60 | 8.18 (5.82-14.9)† | 1.05 (0.05-5.17) | - | 0.70 (0.03-3.43) | 2.09 (0.53-5.68)‡ | - | 0.70 (0.03-3.43) | 1.39 (0.23-4.59) |