Safety of recombinant activated factor VII in patients with warfarin-associated hemorrhages of the central nervous system.
OBJECTIVE
Recombinant Factor VIIa decreases hematoma growth after spontaneous intracerebral hemorrhage (ICH) and rapidly decreases international normalized ratios in patients on warfarin but is also associated with an increased risk for thromboembolic complications. In this study, we assessed the risk of thromboembolic events in patients receiving recombinant Factor VIIa after ICH associated with warfarin treatment.


METHODS
We reviewed the medical charts, laboratory data, and radiological findings of consecutive patients with anticoagulation-related hemorrhages of the central nervous system who received recombinant Factor VIIa at Mayo Clinic Rochester and Mayo Clinic Florida between 2002 and 2009. The primary end point was the frequency of new thromboembolic events, including myocardial infarction, deep vein thrombosis, ischemic stroke, and pulmonary embolism.


RESULTS
We identified 101 patients; 54% had ICH and 30% subdural hematomas. The most common indications for anticoagulation were atrial fibrillation, deep vein thrombosis, and prosthetic valve. Thirteen patients (12.8%) had new thromboembolic events (10 deep vein thromboses and 3 ischemic strokes) within 90 days after recombinant Factor VIIa administration. Eight of these adverse events occurred within 2 weeks of treatment. In patients with ICH, the rate of thromboembolic complications was 5% and all events were venous.


CONCLUSIONS
The risk of thromboembolic events in patients who received recombinant Factor VIIa for anticoagulation-associated ICH was not higher than that seen in patients treated for spontaneous ICH in the Factor Seven for Acute Hemorrhagic Stroke (FAST) trial. Spontaneous deep vein thrombosis was the most common complication in our series.
Department of Neurology, Mayo Clinic, Rochester, Minn 55905, USA.
Maisha T
MT
Robinson
Alejandro A
AA
Rabinstein
James F
JF
Meschia
William D
WD
Freeman
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002493:Central Nervous System Diseases / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control; D002543:Cerebral Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology* / Q000517:prevention & control; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D046748:Hematoma, Epidural, Spinal / Q000139:chemically induced* / Q000453:epidemiology* / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D014859:Warfarin / Q000009:adverse effects*
D011994:Recombinant Proteins; D014859:Warfarin; C103587:recombinant FVIIa; D015942:Factor VIIa