Associated risk of recombinant activated factor VIIa application

Area of Science:

• Cardiology
• Hematology
• Pharmacology

Background:

• Recombinant activated factor VII (rFVIIa) is approved for hemophilia bleeding.
• Off-label use of rFVIIa has been reported for hemostatic effects.
• This study evaluates thromboembolic events in patients receiving rFVIIa therapy.

Purpose of the Study:

• To assess thromboembolic adverse events and side effects.
• To evaluate the safety profile of rFVIIa in a large cohort of cardiac surgical patients.
• To investigate the potential risks associated with off-label rFVIIa use.

Main Methods:

• Retrospective study of 143 cardiac surgical patients treated with rFVIIa between January 2009 and March 2011.
• rFVIIa administered as a last therapeutic option for severe bleeding.
• Analysis of administered blood products, need for re-thoracotomy, mortality, and thrombotic complications.

Main Results:

• 16% of patients experienced thrombotic complications, including mesenteric infarction (n=9), stroke/TIA (n=3), and myocardial infarction (n=3).
• In-hospital mortality was 36%.
• 55% of patients required re-thoracotomy despite maximal procoagulant therapy.

Conclusions:

• Direct causality between rFVIIa and thrombotic events is difficult to establish due to confounding therapies.
• A suspicion exists that rFVIIa administration may increase the rate of mesenteric infarctions.
• Further investigation is warranted to clarify the safety and risks of rFVIIa in this patient population.