Title:Recombinant Activated Factor VII (Eptacog Alfa Activated, NovoSeven®) in Patients with Rare Congenital Bleeding Disorders. A Systematic Review on its Use in Surgical Procedures
Volume: 23
Issue: 7
Author(s): Matteo Nicola Dario Di Minno, Pasquale Ambrosino, Veronika Myasoedova*, Manuela Amato, Itala Ventre, Elena Tremoli and Alessandro Di Minno
Affiliation:
- Unit of Atherosclerosis Prevention, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan,Italy
Keywords:
Glanzmann's thrombasthenia, factor VII deficiency, recombinant activated factor VII, NovoSeven.
Abstract: In the absence of definite guidelines in the area, we have carried a systemic review to provide a thorough
overview concerning the efficacy and safety of recombinant activated factor VII (rFVIIa, NovoSeven®,
Novo Nordisk A/S, Bagsværd, Denmark) in patients with Glanzmann’s thrombasthenia (GT) and FVII deficiency,
undergoing surgical procedures. PubMed, Web of Science, Scopus and EMBASE databases was employed
for the search. Three multicenter registries were identified: the Glanzmann’s Thrombasthenia Registry
(GTR), the Seven Treatment Evaluation Registry (STER), and a German post-marketing surveillance registry (the
WIRK study). In addition, data from 10 case-series and/or single-center experiences have been summarized. We
have found that the following; perioperatively, the hemostatic effectiveness of rFVIIa was high in GT patients
and in those with FVII deficiency undergoing both minor and major surgical procedures. Moreover, in all studies,
rFVIIa was well tolerated. Thus, the current evidence shows an optimal perioperative safety/efficacy profile of
rFVIIa in the setting of these rare bleeding disorders, and provides the rationale for further studies aimed at
evaluating the optimal perioperative anti-hemorrhagic prophylaxis with rFVIIa in GT and in FVII deficient patients.
