title: Recombinant activated factor VII in cardiac surgery: a meta-analysis.
abstract: OBJECTIVE
  Perioperative microvascular bleeding is associated with increased morbidity and mortality and could be reduced by hemostatic drugs such as recombinant activated factor VII (rFVIIa). Few trials have investigated rFVIIa and each individually lacked power to detect a beneficial effect on transfusion of blood products or thromboembolic side effects.
  
  
  METHODS
  Meta-analysis.
  
  
  METHODS
  Hospitals.
  
  
  METHODS
  The authors performed a meta-analysis of 5 clinical trials (1 randomized, 3 propensity matched, and 1 case matched) that included 298 patients and indicated major clinical outcome (survival and thromboembolic events).
  
  
  METHODS
  Four of the 5 studies used rFVII in refractory blood loss. Doses varied between 17 and 70 microg/kg (repeatable) and 90 microg/kg for a single dose.
  
  
  RESULTS
  The authors observed a nonsignificant reduction in the rate of surgical re-exploration (10/76 [13%] in the rFVIIa group v 42/74 [57%] in the control group, odds ratio [OR] = 0.25 [0.01-7.01], p for effect = 0.42), with a trend toward an increase in the rate of perioperative stroke (8/150 [5%] in the rFVIIa v 2/148 [1.4%] in the control arm, OR = 3.17 [0.83-12.10], p = 0.09) and no effect on mortality that was similar in the 2 groups (22/150 [15%] in the rFVIIa group and 22/148 [15%] in the control group [OR = 0.96 (0.50-1.86), p for effect=0.90]).
  
  
  CONCLUSIONS
  This analysis suggests that the hemostatic properties of rFVIIa could reduce the rate of surgical reexploration after cardiac surgery even if an increase of hazardous side effects (eg, perioperative stroke) could not be excluded. Because meta-analyses are hypothesis generating, this issue should be investigated further in large randomized controlled trials.
authors.affiliation: Department of Cardiothoracic Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italia.
authors.forename: Alberto
authors.initials: A
authors.lastname: Zangrillo
authors.forename: Anna
authors.initials: A
authors.lastname: Mizzi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Biondi-Zoccai
authors.forename: Elena
authors.initials: E
authors.lastname: Bignami
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Calabrò
authors.forename: Federico
authors.initials: F
authors.lastname: Pappalardo
authors.forename: Elisa
authors.initials: E
authors.lastname: Dedola
authors.forename: Luigi
authors.initials: L
authors.lastname: Tritapepe
authors.forename: Giovanni
authors.initials: G
authors.lastname: Marino
authors.forename: Giovanni
authors.initials: G
authors.lastname: Landoni
mesh_terms: D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D002986:Clinical Trials as Topic / Q000379:methods; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D009203:Myocardial Infarction / Q000139:chemically induced / Q000209:etiology; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D020521:Stroke / Q000139:chemically induced / Q000209:etiology
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa