Page 196 - Haematologica-April 2018

L. Green et al.
The main objectives of this study were to: (i) describe the burden of major hemorrhage associated with all avail- able OAC in terms of proportion of bleeds which are intracranial, in-hospital case-fatality and morbidity, and duration of hospitalization; (ii) identify risk factors for fatality; (iii) compare characteristics of major hemorrhage between patients treated with warfarin and DOAC for the subgroups anticoagulated for atrial fibrillation or venous thromboembolism, the clinical conditions for which DOAC are indicated.
Methods
Study design
The ORANGE (ORal ANticoagulant aGEnt-associated bleed- ing events reporting system) study was a prospective cohort study that collected information from multiple UK hospitals on the presentation and clinical outcomes of patients who were admitted for a major bleeding episode while on OAC therapy. Ethics approval was obtained for the study from the National Health Service, Health Research Authority (East of England-
Table 2. Bleeding characteristics and outcomes. Total patients
All intracranial hemorrhage Subdural/epidural Intracerebrala Subarachnoidb
All gastrointestinal bleeds
UpperC
Lower
Other bleeds
Visceral
Genitourinary
Musculoskeletal
Miscellaneous (e.g. intra-ocular, puncture and surgical sites)
Provocation of bleeding
Spontaneous
Trauma (excluding fall) Surgery or procedure Fall
Unclassifiedd
Outcomes up to 30 days
Died in hospital
Discharged from hospital Still inpatient at 30 days
Lost to follow-up
Transferred to other hospital
Not submitted
Case fatality by groups
Overall
Age, years
<65 65-74 75-84 85+
Type of oral anticoagulant Warfarin
Direct oral anticoagulant
Site of bleed
All intracranial
All gastrointestinal Other
Number (%)
2,192 (100)
963 (44) 386 (18) 474 (22) 103 (5)
712 (32) 443 (20) 269 (12)
517 (24) 131 (6) 87 (4) 224 (10) 75 (4)
1,434 (65) 200 (9) 105 (5) 432 (20) 21 (1)
446 (20)
1,413 (64) 273 (12)
47 (2)
13 (1)
Followed-up, N
2,132
274 400 840 618
1,719 413
923 704 505
Days to event, median[IQR]
3 [1-8]
7 [3-13]
2 [1-8]
Died (%)
446 (21)
25 (9) 62 (16) 197 (23) 162 (26)
358 (21) 88 (21)
302 33) 91 (13) 53 11)
740
aIncludes 32 with additional bleeds in other sites.bIncludes 17 with additional subdural bleed.cIncludes 18 with additional lower gastrointestinal bleed.dReported as "unknown" or "not available".
haematologica | 2018; 103(4)