Recombinant activated factor VII in cardiac surgery: a meta-analysis.

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. Design: Meta-analysis. Setting: Hospitals. Participants: 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). Interventions: Four of the 5 studies used rFVII in refractory blood loss. Doses varied between 17 and 70 g/kg (repeatable) and 90 g/kg for a single dose. Measurements and Main 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 effect0.90]). 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.