Twenty-two RCTs were included in the review (n=3,184). All trials were reported to have adequate randomisation and allocation concealment. Follow-up ranged from six hours to 90 days.
The requirement for additional red blood cell transfusion was significantly lower in the rFVIIa group than the placebo group (OR 0.54, 95% CI 0.34 to 0.86, I2=49.5%; 11 trials). Mortality was lower in the rFVIIa group, but this did not reach statistical significance. Thromboembolic events were higher in the treatment group compared to placebo, but this was not statistically significant. A statistically significant increase in myocardial infarction rate was reported in the treatment group compared to placebo (2.8% versus 1%; p<0.01).
Subgroup analyses revealed that transfusion requirements were significantly reduced if rFVIIa dose was ≤90υg/kg (OR 0.42, 95% CI 0.19 to 0.93), treatment was administered once (OR 0.33, 95% CI 0.11 to 0.96) and administered therapeutically (OR 0.54, 95% CI 0.34 to 0.86) or prophylactically (OR 0.50, 95% CI 0.25 to 0.99).
Sensitivity analyses did not materially alter the main findings.