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J Hepatol. 2014 Aug;61(2):252-9. doi: 10.1016/j.jhep.2014.03.035. Epub 2014 Apr 5.

Effect of recombinant Factor VIIa on outcome of acute variceal bleeding: an individual patient based meta-analysis of two controlled trials.

Author information

Gastrounit, Medical Division, Hvidovre Hospital, University of Copenhagen, Denmark. Electronic address:
Gastroenterology Unit, Ospedale V Cervello, Palermo, Italy.
Department of Biostatistics, University of Copenhagen, Denmark.
Division of Gastroenterology 3, IRCCS Cà' Granda Ospedale Maggiore Policlinico Foundation, Milano, Italy.
Service d'Hépatologie INSERM U773, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, Clichy, France.
Department of Hepatogastroenterology, La Pitié-Salpêtrière Hospital, Paris, France.
Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clinic - Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), University of Barcelona, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain.



Two randomized controlled studies have evaluated the effect of recombinant Factor VIIa (rFVIIa) on variceal bleeding in cirrhosis without showing significant benefit. The aim of the present study was to perform a meta-analysis of the two trials on individual patient data with special focus on high risk patients.


The primary outcome measure was the effect of rFVIIa on a composite five day endpoint: failure to control bleeding, 5-day rebleeding or death. Analysis was based on intention to treat. High risk was defined as active bleeding on endoscopy while under vasoactive drug infusion and Child-Pugh score >8.


497 patients were eligible for the meta-analysis; 308 (62%) had active variceal bleeding at endoscopy (oozing or spurting) and 283 of these had a Child-Pugh score >8. Analysis on the composite endpoint in all patients with bleeding from oesophageal varices did not show any beneficial treatment effect. However, failure rate for the primary composite end-point was significantly lower in treated patients with active bleeding at endoscopy (17%) compared to placebo (26%, p=0.049). This difference was highly significant in patients with Child-Pugh score >8 and active bleeding at endoscopy (rFVIIa 16%, placebo 27%; p=0.023). No significant treatment effect was found at 42 days. Five thromboembolic events occurred in rFVIIa treated patients compared to none in placebo treated patients.


The current meta-analysis shows a beneficial effect of rFVIIa on the primary composite endpoint of control of acute bleeding, prevention of rebleeding day 1-5 and 5-day mortality in patients with advanced cirrhosis and active bleeding from oesophageal varices at endoscopy. A major drawback of the treatment is a potential increased risk of arterial thrombo-embolic events. This treatment might be considered in patients with lack of control of bleeding after standard treatment.


Acute variceal bleeding; Factor rVIIa; Meta-analysis; Outcome; Treatment

[Indexed for MEDLINE]

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