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The most important complication of long-term oral anticoagulants (OAC) is intracerebral hemorrhage (ICH), which is associated with poor prognosis and high hospital mortality
.
Since the introduction of direct-acting oral anticoagulants (DOACs), the proportion of OAC patients treated with vitamin K antagonists is declining, and DOACs are being used preferentially, partly because the risk of ICH is halved compared with vitamin K antagonists
However, until recently, DOACs lacked a specific antidote for anticoagulant reversal when major bleeding occurred, and prothrombin complex concentrates (PCCs) were widely used as a specific antidote for warfarin
.
Idarucizumab and andexanet alfa represent specific antidote for the hemostatic treatment of DOAC-related bleeding and have shown promising results in previous trials
.
Real-world data from dabigatran related strokes show that in addition to excellent hemostatic effects, idarucizumab has clinical benefits
Although real-world data on the use of PCC in massive bleeding in DOAC patients taking factor Xa inhibitors (fXi) have been published, andexanet alfa is still needed to treat the hemostatic effects and hemostatic effects of andexanet alfa in ICH patients related to taking fXi-intake (fXi-ICH).
Real-world data on clinical results
.
In view of conflicting reports on the hemostatic effects of PCC in the treatment of fXi-ICH, a head-to-head comparison of andexanet alfa with PCC in terms of radiology and clinical results will be valuable
.
Although the ongoing ANNEXA-I trial (Andexanet Alfa, a new anticoagulant for factor Xa inhibitors) addresses this issue in a randomized prospective study design, the recently published case series and unadjusted The registration data provided limited comparative data, and the comparison did not adjust for confounding factors such as baseline hematoma volume
We explored whether the use of andexanet alfa treatment is related to the reduction of hematoma enlargement (HE) rate and the improvement of clinical outcomes in patients with traumatic fXi-ICH compared with conventional care including PCC
Patients with non-traumatic ICH who received apixaban or rivaroxaban within 18 hours of admission were included
.
Patients with secondary ICH or who did not meet the inclusion criteria of the ANNEXA-4 trial were excluded
Apixaban
They compared ANNEXA-4 patients receiving andexanet alfa hemostatic therapy with RETRACE-II patients, who received conventional treatment, mainly given prothrombin complex concentrate
.
The main result is the ratio of HE, which is defined as a relative increase of ≥35%
They found that: in total, 182 factor Xa inhibitor-related ICH patients (85 received andexanet alfa and 97 received routine care) were selected for analysis
.
There were no relevant differences in demographic or clinical characteristics between the two groups
.
11 (14%) of 80 andexanet alfa patients developed thrombosis , and 21 (36%) of 67 routine care patients developed thrombosis (adjusted relative risk, 0.
40 [95% CI, 0.
20-0.
78 ]; P=0.
005), the average overall hematoma volume change was reduced by 7 ml
thrombus
There were no statistically significant differences in hospital mortality or functional outcomes
.
The sensitivity analysis only included routine care patients receiving prothrombin complex concentrate, and the results were consistent
.
There are no statistically significant differences in hospital mortality or functional outcomes
The significance of this study lies in the findings: Compared with conventional care, andexanet alfa is associated with a lower HE rate of traumatic factor Xa inhibitor-related ICH, however, it did not translate into significantly improved clinical results
.
Comparative trials are needed to confirm the benefits of limiting HE, and to explore the clinical results of different patient subgroups and treatment time
.
Original Source:
Huttner HB, Gerner ST, Kuramatsu JB, et al.
Hematoma Expansion and Clinical Outcomes in Patients With Factor-Xa Inhibitor--Related Atraumatic Intracerebral Hemorrhage Treated Within the ANNEXA-4 Trial Versus Real-World Usual Care .
Stroke.
Published online October 14, 2021:STROKEAHA.
121.
034572.
doi:10.
1161/STROKEAHA.
121.
034572