Baseline characteristics of included studies
| . | Sindet-Pedersen et al,8 2018 . | Lutsey et al,14 2019 . | Bott-Kitslaar,9 2018 . | Dawwas et al,10 2019 . | Howe et al,11 2018 . |
|---|---|---|---|---|---|
| Source type | Journal article | Journal article | Journal article | Journal article | Journal article |
| Study design | Retrospective, multicenter registry | Retrospective, market scan data warehouse | Prospective, single-center trial (Mayo Thrombophilia Clinic Registry), observational | Retrospective cohort analysis, market scan and Medicare supplement claims 2014-2016 | Retrospective review, single VA center |
| Mean age, y | 70 A* | 60.4 A | 62.4 A | 61.5 A | 73 A |
| 67 R* | 56.4 R | 58.5 R | 56.5 R | 68 R | |
| Female sex, % | 50.8 A | 50.3 A | 38.7 A | 50.6 A | 2 A |
| 45.3 R | 49.2 R | 48 R | 49.5 R | 4.4 R | |
| Mean weight, kg | NS | NS | 87.6 A | NS | NS |
| 91.3 R | |||||
| Medications, % | 23.6 A | 7 A | 23.8 A | 7.3 A | NS |
| Antiplatelet agents | 18.3 R | 5.1 R | 21.8 R | 4.2 R | |
| Comorbidities, % | 14 A | 17 A | 47 A | 17.7 A | NS |
| Malignancy | 11.4 R | 16.1 R | 39.9 R | 18.9 R | |
| Chronic kidney | 3.9 A | 13.2 A | 2.3 A† | 17.1 A | NS |
| 2.7 R | 7.1 R | 0 R† | 8.5 R | ||
| Total duration of study, mo | 29 | 58 | 24 | 24 | |
| Study groups (total no. of patients in each group) | 2 groups | 2 groups | 2 groups | 2 groups | 2 groups |
| A (1504) | A (6786) | A (302) | A (3091) | A (89) | |
| R (6683) | R (30 982) | R (298) | R (12 163) | R (173) | |
| Primary outcome | All-cause mortality, recurrent VTE, hospitalized bleeding | Hospitalized bleeding | VTE recurrence, major bleeding events | VTE recurrence, major bleeding events | Overall bleeding rates |
| Secondary outcome | Intracranial and gastrointestinal bleeding | CRNMB, and composite of major bleeding and CRNMB | Minor bleeding events | Time to bleeding and location of bleeding | |
| Recurrent VTE, % | 1.71 A | NS | 2.32 A | 0.81 A | NS |
| 1.76 R | 2.01 R | 2.09 R | |||
| Major bleeding, % | 1.17 A | 0.74 A | 3.64 A | 0.91 A | 0.56 A |
| 1.28 R | 1.15 R | 3.20 R | 1.55 R | 1.99 R | |
| Nonmajor/minor bleeding, % | NS | NS | 2.32 A | 5.37 A | 0.28 |
| 6.71 R | 8.90 R | 1.77 R | |||
| Study outcomes reported at | Average 6 mo | 3 mo and 6 mo | 3 mo and overall as 100 per year incidence | <3 mo and >3 mo and 100 person-year | At 3 mo and 100 person-year |
| Major outcomes reported as | Incidence reported as percent events, ARR between 2 groups | Adjusted HR for 100 person-year incidence, number of events at 3 mo | No. of events at <3 mo and >3 mo, HR for the same and also for 100 person-year incidence | No. of events at 3 mo and 100 person-year incidence |
| . | Sindet-Pedersen et al,8 2018 . | Lutsey et al,14 2019 . | Bott-Kitslaar,9 2018 . | Dawwas et al,10 2019 . | Howe et al,11 2018 . |
|---|---|---|---|---|---|
| Source type | Journal article | Journal article | Journal article | Journal article | Journal article |
| Study design | Retrospective, multicenter registry | Retrospective, market scan data warehouse | Prospective, single-center trial (Mayo Thrombophilia Clinic Registry), observational | Retrospective cohort analysis, market scan and Medicare supplement claims 2014-2016 | Retrospective review, single VA center |
| Mean age, y | 70 A* | 60.4 A | 62.4 A | 61.5 A | 73 A |
| 67 R* | 56.4 R | 58.5 R | 56.5 R | 68 R | |
| Female sex, % | 50.8 A | 50.3 A | 38.7 A | 50.6 A | 2 A |
| 45.3 R | 49.2 R | 48 R | 49.5 R | 4.4 R | |
| Mean weight, kg | NS | NS | 87.6 A | NS | NS |
| 91.3 R | |||||
| Medications, % | 23.6 A | 7 A | 23.8 A | 7.3 A | NS |
| Antiplatelet agents | 18.3 R | 5.1 R | 21.8 R | 4.2 R | |
| Comorbidities, % | 14 A | 17 A | 47 A | 17.7 A | NS |
| Malignancy | 11.4 R | 16.1 R | 39.9 R | 18.9 R | |
| Chronic kidney | 3.9 A | 13.2 A | 2.3 A† | 17.1 A | NS |
| 2.7 R | 7.1 R | 0 R† | 8.5 R | ||
| Total duration of study, mo | 29 | 58 | 24 | 24 | |
| Study groups (total no. of patients in each group) | 2 groups | 2 groups | 2 groups | 2 groups | 2 groups |
| A (1504) | A (6786) | A (302) | A (3091) | A (89) | |
| R (6683) | R (30 982) | R (298) | R (12 163) | R (173) | |
| Primary outcome | All-cause mortality, recurrent VTE, hospitalized bleeding | Hospitalized bleeding | VTE recurrence, major bleeding events | VTE recurrence, major bleeding events | Overall bleeding rates |
| Secondary outcome | Intracranial and gastrointestinal bleeding | CRNMB, and composite of major bleeding and CRNMB | Minor bleeding events | Time to bleeding and location of bleeding | |
| Recurrent VTE, % | 1.71 A | NS | 2.32 A | 0.81 A | NS |
| 1.76 R | 2.01 R | 2.09 R | |||
| Major bleeding, % | 1.17 A | 0.74 A | 3.64 A | 0.91 A | 0.56 A |
| 1.28 R | 1.15 R | 3.20 R | 1.55 R | 1.99 R | |
| Nonmajor/minor bleeding, % | NS | NS | 2.32 A | 5.37 A | 0.28 |
| 6.71 R | 8.90 R | 1.77 R | |||
| Study outcomes reported at | Average 6 mo | 3 mo and 6 mo | 3 mo and overall as 100 per year incidence | <3 mo and >3 mo and 100 person-year | At 3 mo and 100 person-year |
| Major outcomes reported as | Incidence reported as percent events, ARR between 2 groups | Adjusted HR for 100 person-year incidence, number of events at 3 mo | No. of events at <3 mo and >3 mo, HR for the same and also for 100 person-year incidence | No. of events at 3 mo and 100 person-year incidence |