Recurrent VTE during the at-risk period in women with and without concomitant hormonal therapy
| Characteristic . | No hormone use . | All hormonal therapies . | Estrogen-containing therapy . | Progestin-only therapy . | ||||
|---|---|---|---|---|---|---|---|---|
| Events/patient-years . | %/year (95% CI) . | Events/patient-years . | %/year (95% CI) . | Events/patient-years . | %/year (95% CI) . | Events/patient-years . | %/year (95% CI) . | |
| All patients | 38/811.0 | 4.7 (3.3-6.4) | 7/187.5 | 3.7 (1.5-7.7) | 4/109.5 | 3.7 (1.0-9.4) | 3/78.0 | 3.8 (0.8-11.2) |
| Age | ||||||||
| <40 years | 19/287.7 | 6.6 (4.0-10.3) | 2/107.4 | 1.9 (0.2-6.7) | 1/57.1 | 1.8 (0.0-9.8) | 1/50.3 | 2.0 (0.1-11.1) |
| ≥40 years | 19/523.4 | 3.6 (2.2-5.7) | 5/80.0 | 6.3 (2.0-14.6) | 3/52.3 | 5.7 (1.2-16.8) | 2/27.7 | 7.2 (0.9-26.1) |
| Time period after randomization | ||||||||
| Days 1-30 | 27/121.0 | 22.3 (14.7-32.5) | 5/28.3 | 17.7 (5.7-41.2) | 4/21.1 | 19.0 (5.2-48.5) | 1/7.2 | 13.9 (0.4-77.4) |
| Days 31-90 | 7/229.9 | 3.1 (1.2-6.3) | 1/56.5 | 1.8 (0.0-9.9) | 0/34.6 | 0.0 (0.0-10.7) | 1/21.9 | 4.6 (0.1-25.4) |
| Days 91-180 | 3/300.1 | 1.0 (0.2-2.9) | 1/73.8 | 1.4 (0.0-7.6) | 0/39.1 | 0.0 (0.0-9.4) | 1/34.7 | 2.9 (0.1-16.1) |
| Days 181-end | 1/160.0 | 0.6 (0.0-3.5) | 0/28.9 | 0.0 (0.0-12.8) | 0/14.7 | 0.0 (0.0-25.1) | 0/14.2 | 0.0 (0.0-26.0) |
| History of DVT/PE before index event | ||||||||
| Yes | 4/162.3 | 2.5 (0.7-6.3) | 0/18.7 | 0.0 (0.0-19.7) | 0/5.8 | 0.0 (0.0-63.1) | 0/12.9 | 0.0 (0.0-28.6) |
| No | 34/648.7 | 5.2 (3.6-7.3) | 7/168.7 | 4.2 (1.7-8.6) | 4/103.6 | 3.9 (1.1-9.9) | 3/65.1 | 4.6 (1.0-13.5) |
| Presentation of index event | ||||||||
| DVT | 21/342.4 | 6.1 (3.8-9.4) | 4/69.6 | 5.7 (1.6-14.7) | 3/48.5 | 6.2 (1.3-18.1) | 1/21.2 | 4.7 (0.1-26.3) |
| PE ± DVT | 17/468.6.4 | 3.6 (2.1-5.8) | 3/117.8 | 2.6 (0.5-7.4) | 1/61.0 | 1.6 (0.0-9.1) | 2/56.8 | 3.5 (0.4-12.7) |
| Prior use of hormonal therapy | ||||||||
| Yes | 13/200.0 | 6.5 (3.5-11.1) | 7/162.0 | 4.3 (1.7-8.9) | 4/103.1 | 3.9 (1.1-9.9) | 3/58.8 | 5.1 (1.1-14.9) |
| No | 25/611.0 | 4.1 (2.7-6.0) | 0/25.5 | 0.0 (0.0-14.5) | 0/6.3 | 0.0 (0.0,58.2) | 0/19.2 | 0.0 (0.0-19.3) |
| Randomized treatment | ||||||||
| Rivaroxaban | 21/390.2 | 5.4 (3.3-8.2) | 3/98.1 | 3.1 (0.6-8.9) | 1/56.2 | 1.8 (0.1-9.9) | 2/41.9 | 4.8 (0.6-17.2) |
| Enoxaparin/VKA | 17/420.8 | 4.0 (2.4-6.5) | 4/89.4 | 4.5 (1.2-11.5) | 3/53.3 | 5.6 (1.2-16.5) | 1/36.1 | 2.8 (0.1-15.4) |
| Characteristic . | No hormone use . | All hormonal therapies . | Estrogen-containing therapy . | Progestin-only therapy . | ||||
|---|---|---|---|---|---|---|---|---|
| Events/patient-years . | %/year (95% CI) . | Events/patient-years . | %/year (95% CI) . | Events/patient-years . | %/year (95% CI) . | Events/patient-years . | %/year (95% CI) . | |
| All patients | 38/811.0 | 4.7 (3.3-6.4) | 7/187.5 | 3.7 (1.5-7.7) | 4/109.5 | 3.7 (1.0-9.4) | 3/78.0 | 3.8 (0.8-11.2) |
| Age | ||||||||
| <40 years | 19/287.7 | 6.6 (4.0-10.3) | 2/107.4 | 1.9 (0.2-6.7) | 1/57.1 | 1.8 (0.0-9.8) | 1/50.3 | 2.0 (0.1-11.1) |
| ≥40 years | 19/523.4 | 3.6 (2.2-5.7) | 5/80.0 | 6.3 (2.0-14.6) | 3/52.3 | 5.7 (1.2-16.8) | 2/27.7 | 7.2 (0.9-26.1) |
| Time period after randomization | ||||||||
| Days 1-30 | 27/121.0 | 22.3 (14.7-32.5) | 5/28.3 | 17.7 (5.7-41.2) | 4/21.1 | 19.0 (5.2-48.5) | 1/7.2 | 13.9 (0.4-77.4) |
| Days 31-90 | 7/229.9 | 3.1 (1.2-6.3) | 1/56.5 | 1.8 (0.0-9.9) | 0/34.6 | 0.0 (0.0-10.7) | 1/21.9 | 4.6 (0.1-25.4) |
| Days 91-180 | 3/300.1 | 1.0 (0.2-2.9) | 1/73.8 | 1.4 (0.0-7.6) | 0/39.1 | 0.0 (0.0-9.4) | 1/34.7 | 2.9 (0.1-16.1) |
| Days 181-end | 1/160.0 | 0.6 (0.0-3.5) | 0/28.9 | 0.0 (0.0-12.8) | 0/14.7 | 0.0 (0.0-25.1) | 0/14.2 | 0.0 (0.0-26.0) |
| History of DVT/PE before index event | ||||||||
| Yes | 4/162.3 | 2.5 (0.7-6.3) | 0/18.7 | 0.0 (0.0-19.7) | 0/5.8 | 0.0 (0.0-63.1) | 0/12.9 | 0.0 (0.0-28.6) |
| No | 34/648.7 | 5.2 (3.6-7.3) | 7/168.7 | 4.2 (1.7-8.6) | 4/103.6 | 3.9 (1.1-9.9) | 3/65.1 | 4.6 (1.0-13.5) |
| Presentation of index event | ||||||||
| DVT | 21/342.4 | 6.1 (3.8-9.4) | 4/69.6 | 5.7 (1.6-14.7) | 3/48.5 | 6.2 (1.3-18.1) | 1/21.2 | 4.7 (0.1-26.3) |
| PE ± DVT | 17/468.6.4 | 3.6 (2.1-5.8) | 3/117.8 | 2.6 (0.5-7.4) | 1/61.0 | 1.6 (0.0-9.1) | 2/56.8 | 3.5 (0.4-12.7) |
| Prior use of hormonal therapy | ||||||||
| Yes | 13/200.0 | 6.5 (3.5-11.1) | 7/162.0 | 4.3 (1.7-8.9) | 4/103.1 | 3.9 (1.1-9.9) | 3/58.8 | 5.1 (1.1-14.9) |
| No | 25/611.0 | 4.1 (2.7-6.0) | 0/25.5 | 0.0 (0.0-14.5) | 0/6.3 | 0.0 (0.0,58.2) | 0/19.2 | 0.0 (0.0-19.3) |
| Randomized treatment | ||||||||
| Rivaroxaban | 21/390.2 | 5.4 (3.3-8.2) | 3/98.1 | 3.1 (0.6-8.9) | 1/56.2 | 1.8 (0.1-9.9) | 2/41.9 | 4.8 (0.6-17.2) |
| Enoxaparin/VKA | 17/420.8 | 4.0 (2.4-6.5) | 4/89.4 | 4.5 (1.2-11.5) | 3/53.3 | 5.6 (1.2-16.5) | 1/36.1 | 2.8 (0.1-15.4) |