Table 1.
Descriptive Characteristics of Cases Reporting CSVV Associated with DOACs in FAERS or Published Literature from Approval of each DOAC through March 16, 2018 (n=50)a,b
| Selected Characteristics | Dabigatran (n=9) | Rivaroxaban (n=26) | Apixaban (n=14) | Edoxaban (n=1) |
|---|---|---|---|---|
| FDA approval date | 10/19/2010 | 07/11/2011 | 12/28/2012 | 01/08/2015 |
| Age (years)c | n=8 | n=25 | n=14 | |
| Mean | 69 | 65 | 73 | - |
| Median age, years (range) | 70 (54–78) | 68 (28–87) | 76 (49–90) | - |
| Sex | ||||
| Male | 6 | 10 | 9 | 1 |
| Female | 3 | 16 | 5 | - |
| Reported reason for use | ||||
| Atrial fibrillation | 8 | 14 | 10 | 1 |
| Venous thromboembolism | 1 | 10 | 4 | - |
| Not reported | - | 2 | - | - |
| Time-to-onset (days) | ||||
| Median (range) | 10 (2–23) | 12 (1–120) | 10 (1–547) | 7 |
| Biopsy confirmed | 7 | 18 | 7 | 1 |
| Physician diagnosed | 2 | 8 | 7 | - |
| Dechallenge/Rechallenge | ||||
| Positive dechallenge | 9 | 26 | 13 | 1 |
| Rechallenge | 1 | 3 | - | - |
| Not reported | - | - | 1 | - |
| Type of CSVV | ||||
| Leukocytoclastic | 8 | 15 | 8 | - |
| Henoch-Schonlein | - | 4 | - | - |
| Not specifiedd | 1 | 7 | 6 | 1 |
| Clinical Interventione | ||||
| Discontinuation of offending DOAC | 9 | 25 | 13 | 1 |
| Treatment with corticosteroids | 6 | 17 | 3 | 1 |
| Offending anticoagulant substitutione | ||||
| Another DOAC | 4 | 3 | 2 | 1 |
| Vitamin K antagonist | 2 | 5 | 1 | - |
| Low molecular weight heparin | 1 | 5 | 2 | - |
| Not reported | 2 | 13 | 9 | - |
| Serious Outcomese,f | ||||
| Hospitalization | 8 | 19 | 9 | 1 |
| Life threatening | - | 1 | 1 | - |
| Other serious | 1 | 11 | 12 | - |
| Causality Assessment | ||||
| Probable | 7 | 18 | 7 | 1 |
| Possible | 2 | 8 | 7 | - |
Literature search was conducted through September 20, 2019.
Betrixaban the newest approved DOAC was not included in this study due to its limited market uptake.
Refers to the cases in which age information was reported.
Include non-specific types of CSVV (e.g., vasculitis/ulcerative/necrotic vasculitis).
More than one clinical intervention, outcome, or DOAC may have been reported per case.
Per 21 CFR 314.80, the regulatory definition of serious is any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, and other serious important medical events.