Estimates of VTE recurrence and bleeding incidence relevant to hormone-related VTE
| Clinical context . | Study type . | Absolute risk estimates . | Comments . | References . |
|---|---|---|---|---|
| VTE recurrence risk | ||||
| Women (all ages, various VTE types) • Stopped anticoagulants | Individual patient data meta-analysis including data (n = 1268) | VTE recurrence: 5.3% (95% CI, 4.1-6.7) after 1 year 9.1% (95% CI, 7.3-11.3) after 3 years | In this study hormone-related VTE were grouped with unprovoked VTE. | 37 |
| Women with a first hormonal- contraceptive–related VTE, • Stopped anticoagulants • Stopped hormonal contraceptives | Two systematic reviews and meta-analyses (n = 3 112 and n = 1537) | VTE recurrence: 1.3 (95% CI, 0.7-2.4) and 1.2 (95% CI, 0.9-1.6) per 100 person-years | Several studies in these systematic reviews overlapped. | 25,26 |
| Women with a first VTE • Stopped anticoagulant therapy (VKA) • Started or continued hormonal contraceptives | Cohort study (n = 650) | VTE recurrence: 4.8 (95% CI, 2.3-8.9) per 100 person-years, vs 1.5 (95% CI, 1.1-2.3) among those who did not use combined hormonal contraceptives | Similar results for women using only combined hormonal contraceptives during the first VTE and those who had an additional otherwise provoking factor (eg, surgery, cast, immobility, etc). | 11 |
| Women and men (all ages) with a provoked VTE by a nonsurgical risk factor • Stopped anticoagulant therapy | Systematic review of cohort studies (n = 509) | VTE recurrence: 4.2 (95% CI, 2.8-5.6) per 100 person-years | Estimate can be used to approximate VTE recurrence risk after a pregnancy-related VTE, no direct data available in this group. | 38 |
| Bleeding risk | ||||
| Women and men (all ages, unprovoked VTE) • During extended oral anticoagulant therapy with DOAC | Systematic review and meta-analyses (n = 7220) | Major bleeding: 1.1 events (95% CI, 0.7-1.6 events) per 100 person-years | No data on reduced-dose strategy. No data on heavy menstrual bleeding. | 39 |
| Women and men (all ages, unprovoked VTE) • After stopping anticoagulant therapy | Systematic review and meta-analyses (n = 8740) | Major bleeding: 0.4 events (95% CI, 0.2-0.5) per 100 person- years | 40 | |
| Clinical context . | Study type . | Absolute risk estimates . | Comments . | References . |
|---|---|---|---|---|
| VTE recurrence risk | ||||
| Women (all ages, various VTE types) • Stopped anticoagulants | Individual patient data meta-analysis including data (n = 1268) | VTE recurrence: 5.3% (95% CI, 4.1-6.7) after 1 year 9.1% (95% CI, 7.3-11.3) after 3 years | In this study hormone-related VTE were grouped with unprovoked VTE. | 37 |
| Women with a first hormonal- contraceptive–related VTE, • Stopped anticoagulants • Stopped hormonal contraceptives | Two systematic reviews and meta-analyses (n = 3 112 and n = 1537) | VTE recurrence: 1.3 (95% CI, 0.7-2.4) and 1.2 (95% CI, 0.9-1.6) per 100 person-years | Several studies in these systematic reviews overlapped. | 25,26 |
| Women with a first VTE • Stopped anticoagulant therapy (VKA) • Started or continued hormonal contraceptives | Cohort study (n = 650) | VTE recurrence: 4.8 (95% CI, 2.3-8.9) per 100 person-years, vs 1.5 (95% CI, 1.1-2.3) among those who did not use combined hormonal contraceptives | Similar results for women using only combined hormonal contraceptives during the first VTE and those who had an additional otherwise provoking factor (eg, surgery, cast, immobility, etc). | 11 |
| Women and men (all ages) with a provoked VTE by a nonsurgical risk factor • Stopped anticoagulant therapy | Systematic review of cohort studies (n = 509) | VTE recurrence: 4.2 (95% CI, 2.8-5.6) per 100 person-years | Estimate can be used to approximate VTE recurrence risk after a pregnancy-related VTE, no direct data available in this group. | 38 |
| Bleeding risk | ||||
| Women and men (all ages, unprovoked VTE) • During extended oral anticoagulant therapy with DOAC | Systematic review and meta-analyses (n = 7220) | Major bleeding: 1.1 events (95% CI, 0.7-1.6 events) per 100 person-years | No data on reduced-dose strategy. No data on heavy menstrual bleeding. | 39 |
| Women and men (all ages, unprovoked VTE) • After stopping anticoagulant therapy | Systematic review and meta-analyses (n = 8740) | Major bleeding: 0.4 events (95% CI, 0.2-0.5) per 100 person- years | 40 | |