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Reversal of Warfarin-Induced Excessive Anticoagulation with Recombinant Human Factor VIIa Concentrate

Ruby Anne E. Deveras, MD, and Craig M. Kessler, MD

3 December 2002 | Volume 137 Issue 11 | Pages 884-888

Background: Bleeding associated with warfarin anticoagulation correlates directly to duration and degree of international normalized ratio (INR) elevation above the therapeutic range. Safe and rapid reversal of excessive anticoagulation is occasionally needed to treat or avoid hemorrhagic complications.

Objective: To evaluate the efficacy and safety of human recombinant factor VIIa (rFVIIa) concentrate in persons requiring rapid reversal of the effects of warfarin.

Design: Uncontrolled case series.

Setting: Academic medical center.

Patients: 13 patients with critically increased INRs requiring immediate reversal of warfarin-induced anticoagulation.

Measurements: Prothrombin time and INR were measured before and after administration of varying doses of rFVIIa.

Results: Critically prolonged INR and bleeding complications were treated successively and rapidly in all patients, regardless of rFVIIa dose (range, 15 to 90 µg/kg of body weight). Indications for use of rFVIIa included an INR greater than 10 in high-risk persons (n = 5), clinical hemorrhage (n = 4), and diagnostic or therapeutic procedures (n = 4).

Conclusion: Safe, rapid, and effective administration of rFVIIa corrects critically prolonged INRs and can avert or reverse bleeding associated with warfarin anticoagulation.

Editors' Notes Context Traditional treatments (fresh-frozen plasma, prothrombin complex concentrate) for rapid reversal of excessive anticoagulation from warfarin are limited by inconvenience and potentially serious side effects. Contribution This prospective case series showed that a single infusion of human recombinant factor VIIa concentrate (rFVIIa) immediately reduced international normalized ratios without adverse effects in 13 patients who needed rapid reversal of excessive warfarin-induced anticoagulation for various reasons. Cautions Before changing treatment policy on the basis of these preliminary findings, physicians should watch for controlled studies that compare outcomes, side effects, and costs in patients treated with rFVIIa versus traditional therapies. –The Editors

 

Author and Article Information

From Georgetown University Medical Center, Washington, DC.

Potential Financial Conflicts of Interest:Consultancies: R.A.E. Deveras, C.M. Kessler. Honoraria: C.M. Kessler.

Requests for Single Reprints: Ruby Anne E. Deveras, MD, Division of Hematology and Oncology, Georgetown University Medical Center, 3800 Reservoir Road NW, Washington, DC 20007-2197; e-mail, rad{at}georgetown.edu.

Current Author Addresses: Drs. Deveras and Kessler: Division of Hematology and Oncology, Georgetown University Medical Center, Lombardi Cancer Center, 3800 Reservoir Road NW, Washington, DC 20007-2197.

Author Contributions: Conception and design: R.A.E. Deveras.

Analysis and interpretation of the data: R.A.E. Deveras, C.M. Kessler.

Drafting of the article: R.A.E. Deveras.

Critical revision of the article for important intellectual content: C.M. Kessler.

Final approval of the article: C.M. Kessler.

Provision of study materials or patients: C.M. Kessler.

Collection and assembly of data: R.A.E. Deveras.

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