Safety of Recombinant Activated Factor VII in Patients With Warfarin-Associated Hemorrhages of the Central Nervous System

Abstract

Background and Purpose-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. Conclusion-The risk of thromboembolic events in patients who received recombinant Factor VIIa for anticoagulationassociated 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. (Stroke.

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

“…Compared to a large case series by Robinson and colleagues, where 101 patients treated with variable doses of rFVIIa for warfarin-associated hemorrhages of the brain and spinal canal had no cardiac thromboembolic events [19], we found a much higher incidence of cardiac thromboembolic events following wICH regardless of rFVIIa use. Differences in location of hemorrhages, methods use for cardiac thromboembolism screening, and differences in rFVIIa dosage likely have contributed to the difference in results between our study and the study by Robinson et al Our results on rFVIIa-related extra-cardiac thromboembolism are more consistent with that reported by Robison et al (DVT 10%, ischemic stroke 3%) and by the FAST study (DVT 4-5%, PE 1%, ischemic stroke 3-6%).…”

Prophylactic Activated Recombinant Factor VII in Liver Resection and Liver Transplantation: Systematic Review and Meta-Analysis

“…The intervention did not increase the risk for thromboembolic events. An increased risk has been reported elsewhere, although this observation could reflect the specific characteristic of the clinical setting [17], [26].…”

Rapid Anticoagulation Reversal With Prothrombin Complex Concentrate Before Emergency Brain Tumor Surgery

“…The 4-factor PCC Beriplex P/N was introduced at our institution when reports on its efficacy for safe anticoagulant reversal emerged. 19 The use of recombinantactivated factor VII has also been used to urgently restore hemostasis in anticoagulated patients, 20 and especially in the United States where 4-factor PCC were not available until recently, the use of recombinant factor VII is included in reversal protocols. 21 Recombinant factor VIIa is associated with high thromboembolic risks 22 and furthermore, its costs clearly exceed the expenses for PCC.…”