A Cochrane review included 29 studies with a total of 4 290 subjects; 28 were placebo-controlled, double-blind RCTs and one compared different doses of rFVIIa. Sixteen trials involving 1 361 participants examined the prophylactic use of rFVIIa. There was no evidence of mortality benefit (RR 1.04, 95% CI 0.55 to 1.97). There was decreased blood loss (MD -297 mL, 95% CI -416 to -178) and decreased red cell transfusion requirements (MD -261 mL, 95% CI -367 to -154) with rFVIIa treatment; however these values were likely overestimated due to the inability to incorporate data from trials showing no difference of rFVIIa treatment compared to placebo. There was a trend in favour of rFVIIa in the number of participants transfused (RR 0.85, 95% CI 0.72 to 1.01), but there was a trend against rFVIIa with respect to thromboembolic adverse events (RR 1.35, 95% CI 0.82 to 2.25).
Thirteen trials involving 2 929 participants examined the therapeutic use of rFVIIa. There were no outcomes where any observed advantage, or disadvantage, of rFVIIa over placebo could not have been observed by chance alone. There was a trend in favour of rFVIIa for reducing mortality (RR 0.91, 95% CI 0.78 to 1.06). However, there was a trend against rFVIIa for increased thromboembolic adverse events (RR 1.14, 95% CI 0.89 to 1.47).
Comment: The quality of evidence is downgraded by study limitations (unclear allocation concealment).