Key result
In patients with VKA-associated intracerebral hemorrhage, no reversal was associated with higher 30-day case fatality compared to combined FFP and PCC (61.7% vs 27.8%; HR 2.540, 95% CI 1.784-3.616).
Why the study?
Does the choice of reversal strategy (FFP, PCC, both, or neither) affect 30-day case fatality in patients with vitamin K antagonist-associated intracerebral hemorrhage?
Cohort (n=1,547)
Yes
Does the choice of reversal strategy (FFP, PCC, both, or neither) affect 30-day case fatality in patients with vitamin K antagonist-associated intracerebral hemorrhage?
Hazard Ratio: 2.54 (95% CI 1.784–3.616)
Absolute Event Rate: 61.7% vs 27.8%
p-value: p=<0.001
In patients with VKA-associated intracerebral hemorrhage, combining FFP and PCC may be associated with lower 30-day case fatality compared to either treatment alone or no reversal.
May support combination reversal in VKA-ICH; leaves open need for RCTs to confirm survival benefit.
OBJECTIVE: There is little evidence to guide treatment strategies for intracerebral hemorrhage on vitamin K antagonists (VKA-ICH). Treatments utilized in clinical practice include fresh frozen plasma (FFP) and prothrombin complex concentrate (PCC). Our aim was to compare case fatality with different reversal strategies. METHODS: We pooled individual ICH patient data from 16 stroke registries in 9 countries (n = 10 282), of whom 1,797 (17%) were on VKA. After excluding 250 patients with international normalized ratio < 1.3 and/or missing data required for analysis, we compared all-cause 30-day case fatality using Cox regression. RESULTS: We included 1,547 patients treated with FFP (n = 377, 24%), PCC (n = 585, 38%), both (n = 131, 9%), or neither (n = 454, 29%). The crude case fatality and adjusted hazard ratio (HR) were highest with no reversal (61.7%, HR = 2.540, 95% confidence interval [CI] = 1.784-3.616, p < 0.001), followed by FFP alone (45.6%, HR = 1.344, 95% CI = 0.934-1.934, p = 0.112), then PCC alone (37.3%, HR = 1.445, 95% CI = 1.014-2.058, p = 0.041), compared to reversal with both FFP and PCC (27.8%, reference). Outcomes with PCC versus FFP were similar (HR = 1.075, 95% CI = 0.874-1.323, p = 0.492); 4-factor PCC (n = 441) was associated with higher case fatality compared to 3-factor PCC (n = 144, HR = 1.441, 95% CI = 1.041-1.995, p = 0.027). INTERPRETATION: The combination of FFP and PCC might be associated with the lowest case fatality in reversal of VKA-ICH, and FFP may be equivalent to PCC. Randomized controlled trials with functional outcomes are needed to establish the most effective treatment.
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Parry‐Jones et al. (2015) conducted a cohort in intracerebral hemorrhage on vitamin K antagonists (n=1,547). No reversal vs. Combined FFP and PCC was evaluated on all-cause 30-day case fatality (HR 2.540, 95% CI 1.784-3.616, p=<0.001). In patients with VKA-associated intracerebral hemorrhage, no reversal was associated with higher 30-day case fatality compared to combined FFP and PCC (61.7% vs 27.8%; HR 2.540, 95% CI 1.784-3.616).
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