Thromboembolic risks of recombinant factor VIIa Use in warfarin-associated intracranial hemorrhage: a case–control studyReportar como inadecuado

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BMC Neurology

, 12:158

Cerebrovascular disease and stroke


BackgroundRecombinant factor VIIa rFVIIa may be used for rapid hemostasis in life-threatening hemorrhage. In warfarin-associated intracerebral hemorrhage wICH, FVIIa use is controversial and may carry significant thromboembolic risks. We compared incidence of baseline thromboembolic risk factors and thromboembolism rates in wICH patients treated with additional rFVIIa to those treated with standard therapy of fresh frozen plasma FFP and vitamin K alone.

MethodsWe identified 45 consecutive wICH patients treated with additional rFVIIa over 5-year period, and 34 consecutive wICH patients treated with standard therapy alone as comparison group. We compared the incidence of post-hemorrhage cardiac and extra-cardiac thromboembolic complications between two treatment groups, and used logistic regression to adjust for significant confounders such as baseline thromboembolic risk factors. We performed secondary analysis comparing the quantity of FFP transfused between two treatment cohorts.

ResultsBoth rFVIIa-treated and standard therapy-treated wICH patients had a high prevalence of pre-existing thromboembolic diseases including atrial fibrillation 73% vs 68%, deep venous thrombosis DVT or pulmonary embolism PE 22% vs 18%, coronary artery disease CAD 38% vs 32%, and abnormal electrocardiogram EKG 78% vs 85%. Troponin elevation following wICH was prevalent in both groups 47% vs 41%. Clinically significant myocardial infarction MI, defined as troponin > 1.0 ng-dL, occurred in 13% of rFVIIa-treated and 6% of standard therapy-treated patients p=0.52. Past history of CAD p=0.0061 and baseline abnormal EKG p=0.02 were independently associated with clinically significant MI following wICH while rFVIIa use was not. The incidences of DVT-PE 2% vs 9%; p=0.18 and ischemic stroke 2% vs 0%; p=0.38 were similar between two treatment groups. Recombinant FVIIa-treated patients had lower mean INR at 3 p=0.0001 and 6 hours p<0.0001 and received fewer units of FFP transfusion 3 vs 5; p=0.003.

ConclusionsPre-existing thromboembolic risk factors as well as post-hemorrhage troponin elevation are prevalent in wICH patients. Clinically significant MI occurs in up to 13% of wICH patients. rFVIIa use was not associated with increased incidence of clinically significant MI or other venous or arterial thromboembolic events in this wICH cohort.

KeywordsActivated recombinant factor VII Intracerebral hemorrhage Thromboembolism Warfarin AbbreviationsAFAtrial fibrillation

CADCoronary artery disease

DVTDeep venous thrombosis


FASTFactor Seven for Acute Hemorrhagic Stroke study

FFPFresh frozen plasma

IPHIntra-parenchymal hemorrhage

PCCProthrombin complex concentrate

PEPulmonary embolism

rFVIIaRecombinant factor VIIa

SAHSubarachnoid hemorrhage

STEMIST-elevation myocardial infarction

SDHSubdural hemorrhage

TIATransient ischemic attack

wICHWarfarin-associated intracerebral hemorrhage.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2377-12-158 contains supplementary material, which is available to authorized users.

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