Key result
Procoagulant therapy with rFVIIa and 3-factor PCC increased the percentage of patients reaching an INR < 1.3 compared to control (73.8% vs 43.2%, P=0.004), without significant mortality benefit.
Why the study?
Do procoagulants (rFVIIa, rFVIIa + 3-factor PCC, or 4-factor PCC) improve clinical outcomes or INR reversal in warfarin patients with intracranial hemorrhage compared with no procoagulant?
Cohort (n=197)
Do procoagulants (rFVIIa, rFVIIa + 3-factor PCC, or 4-factor PCC) improve clinical outcomes or INR reversal in warfarin patients with intracranial hemorrhage compared with no procoagulant?
Absolute Event Rate: 73.8% vs 43.2%
p-value: p=0.004
In warfarin patients with intracranial hemorrhage, the use of procoagulants improved INR reversal but did not significantly improve mortality and was associated with thromboembolic complications, suggesting the need for judicious use.
No reversal strategy showed superiority in this observational analysis; leaves open optimal procoagulant choice for warfarin-related ICH.
: When patients on anticoagulation present with intracranial bleeding, stopping the bleeding is paramount. Despite the availability of multiple options to reverse anticoagulation, no study has directly compared the effectiveness of the procoagulants recombinant activated factor VII (rFVIIa), the rFVIIa and 3-factor prothrombin complex concentrate (PCC) combination, and 4-factor PCC on improving patient outcomes compared with a control. This study examined the medical records of 197 warfarin patients with intracranial hemorrhage, an initial international normalized ratio (INR) greater than 1.5, and who received rFVIIa (26), the combination (84), 4-PCC (50), or no procoagulant, the control group (37). Mortality, length of stay, location discharged, change in INR prior to and postdrug administration, plasma use, and number of thromboembolic complications were used to assess effectiveness. Although INR decreased in all groups (1.31 rFVIIa vs. 2.04 combination vs. 1.41 4-PCC vs. 1.20 control, P = 0.07), the combination group had the greatest percentage to reach an INR of less than 1.3 (46.2 vs. 73.8 vs. 58.0 vs. 43.2%, P = 0.004). The combination and control groups experienced a high, though nonsignificant, number of thromboembolic complications (5.6 vs. 19.0 vs. 7.7 vs. 12.9%, P = 0.533). The rFVIIa group used the most plasma and had the longest length of stay. Mortality did not differ significantly among groups. Although the combination improved INR compared with control, this had a high number of complications. Judicious use of procoagulants is recommended due to their expense and lack of significant improvement in outcomes compared with control.
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DeLoughery et al. (2017) conducted a cohort in Intracranial hemorrhage in patients on warfarin (n=197). Procoagulants (rFVIIa, rFVIIa + 3-factor PCC, or 4-factor PCC) vs. No procoagulant was evaluated on Percentage to reach an INR of less than 1.3 (p=0.004). Procoagulant therapy with rFVIIa and 3-factor PCC increased the percentage of patients reaching an INR < 1.3 compared to control (73.8% vs 43.2%, P=0.004), without significant mortality benefit.
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